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Internal Auditors
Training Programme
on
Quality Management System
ISO/TS 16949 : 2002
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PRINCIPLES OF AUDITING
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PRINCIPLES OF AUDITINGDictionary definition of audit
“Audit (noun)
An examination of accounts by one or more duly authorised persons.”
“Audit (verb)
To examine by reference to vendors.”
ISO 8402 definition of quality audits
“A systematic and independent examination to determine whether quality activities comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.”
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AUDITOR (ISO 10011)
“A person who has the qualification and is
authorised to perform all or any part of a quality
system audit.”
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TYPE OF AUDITSAudits may be described using a number of different terms INTERNAL versus EXTERNAL
1ST PARTY2ND PARTY3RD PARTYSince we come across these terms frequently, when discussing different types of audits, it is important to understand how they are used.
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INTERNAL AUDIT
An audit that is performed on an
organisation by or on behalf of itself is
commonly called an internal audit. The
actual auditors may be internal
employees, or may be contracted auditors
to perform the auditing services.
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EXTERNAL AUDIT
An audit that is performed on an organisation by or on behalf of a separate organisation is commonly referred to as an external audit. There may be several different kinds of external audits, depending on the nature of the client and the purpose of the audit.
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1ST PARTY AUDITA 1st party audit is another term used for
‘internal audits’. Where an orgnisation commissions an audit of itself, for its own internal purposes. Satisfies the ‘EMS Audit’ clause of ISO 14001. May be performed by external auditors or internal auditors, but never by 2nd or 3rd party auditors.
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2ND PARTY AUDITA 2nd Party Audit is one type of external
audit, where an organisation is audited by an outside, external organisation for the purposes of the outside organisation. Common examples would include a supplier audit (an audit by a potential customer performed on a potential supplier), an an audit of a potential financial partner (joint venture or purchase etc.)
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3RD PARTY AUDITA 3rd party audit is a specific type of
external audit that is done for the purpose of objectively verifying the auditee’s circumstances. An ISO 14001 certification audit is the most common example of a 3rd party verification audit.
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Client Auditor Auditee
1st party audit
Internal Internal or External
Internal
2nd party audit
External External Internal
3rd party audit
Internal External Internal
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WHY IS AUDITING NECESSARY ?
a. To determine conformity or non-conformity of the quality system elements with specified requirements.
b. To determine the effectiveness of the implemented quality system in meeting specified quality objectives.
c. To afford an opportunity to improve the quality system.
d. To provide managers with information.
Quality audits are an essential element of the Quality Assurance function. The general objectives of quality audits are –
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a. As a routine examination of the organisation quality system to verify that it continues to meet requirements.
b. As a consequence of particular circumstances such as variation in the product quality, organisational modifications or to follow up corrective actions from a previous audit.
c. For evaluation of the organisation’s quality system against quality systems standards.
Internal quality systems audit should be initiated :
Audits may also be needed for meeting regulatory requirements.
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THE AUDIT LIFE CYCLE
1) PLANNING.
2) CONDUCTING THE AUDIT.
3) ANALYSIS OF RESULTS.
4) REPORTS AND CORRECTIVE ACTION (INCLUDING
FOLLOW-UP AUDITS).
A quality systems audit can be broken down into four basic phases :
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AUDIT PLANNING
1) What type of audit ?
2) Gather preliminary information.
3) Develop check lists.
4) Who will perform audit ?
5) Arrange time of audit.
6) Examine previous audit results.
7) Talk to other departments.
8) Prepare audit plan.
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AUDIT CHECK LISTS
Check lists can beBased on recognised quality standards.Developed around departments operating system.Based on company standards and procedures.Based on product/customer requirements.
Check lists act asA guide.An aide memoire.Provider of continuity.A record of audit coverage.
An extremely powerful audit tool, if used correctly :
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AUDITOR QUALITIES1) Confident.2) Diplomat.3) Good listener.4) Constructive.5) Objective.6) Analytical.7) Familiar with Quality System.8) Professional.
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VERIFY THAT THE DEFINED SYSTEM
ELEMENTS EXIST AND ARE IMPLEMENTED
AUDITORS TASK
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COLLECTING EVIDENCE
BY
CONDUCTING INTERVIEWS
EXAMINATION OF DOCUMENTS/ PRODUCTS
OBSERVATION OF ACTIVITIES
OBSERVATION OF CONDITIONS/ HOUSE KEEPING
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CRITICAL SUCCESS FACTORS
INTERVIEW THE RIGHT PEOPLE
BE WELL PREPARED
LET THE INTERVIEWEE RELAX
ADJUST STYLE TO SUIT
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A BAD AUDITOR
IS ONE
WHO
CULTIVATES
ONE-WAY COMMUNICATION
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AUDITORS
MUST LEARN
TO LISTEN
WITH THE MIND
AS WELL AS
THE EARS
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POINTS TO REMEMBER
Talk to the person who does the job
Don’t talk down
Talk the language of the auditee
Speak clearly
Rephrase the question if not understood
Don’t confuse – pose one question at a time
Come back if information is not immediately available
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AUDITOR SHOULD ENSURE
• WHAT HE IS LOOKING FOR ?
• WHAT IS HE LOOKING AT ?
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AUDIT PROCESS
• BE OPEN.
• DISCUSS.
• CLARIFY.
• GET FACTS.
• HELP.
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VERIFICATION
• RANDOM BASIS.
• CHOSEN BY THE AUDITOR.
• PERMISSION SOUGHT.
• ESTABLISH AND AGREE FACTS.
• REMAIN DISINTERESTED.
• REMAIN POLITE.
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TIME WASTERS
INTRODUCTION AND PRESENTATIONS.
A WALK ROUND – THE LONG WAY.
COFFEE, TEA, LUNCH.
THE RED HERRING.
THE UNIMPORTANT WAY.
TOP BRASS.
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TO RECORD A NON-CONFORMANCE THE FOLLOWING INFORMATION IS NECESSARY :
1. THE FACTS FOUND/OBSERVED.
2. WHERE THE FACTS WERE FOUND.
3. WHY IT IS A NON-CONFORMANCE.
4. WHO WAS INVOLVED (OPTIONAL)
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A SIGNIFICANT NON-COMPLIANCE WITH A QUALITY SYSTEM REQUIREMENT.OR
A FAILURE OF, OR COMPLETE OMISSION OF A QUALITY SYSTEM REQUIREMENT.ORA SIGNIFICANT NUMBER OF MINOR NON-CONFORMITIES CONCERNING THE SAME QUALITY SYSTEM REQUIREMENT.
MAJOR NON-CONFORMITY
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AN ISOLATED INCIDENT OF A FAILURE TO
COMPLY WITH A PROCEDURE OR QUALITY
SYSTEM REQUIREMENTS.
MINOR NON-CONFORMITY
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IF ADEQUATE NOTES ARE NOT TAKEN IT WILL BE VERY DIFFICULT TO RECALL WHAT HAS BEEN OBSERVED.
Do not trust your memory, write down information as you go.
Do not clutter your mind with trivia.
Use your check list and record on it if you wish.
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REMEMBER TO LISTEN TO WHAT IS SAID
AND OBSERVE AT ALL TIMES, ANALYSE
AND RECORDED WHAT IS IMPORTANT.
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INTERNAL AUDIT REQUIREMENT
– ISO/TS 16949 - 2002
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8.2.2 Internal audit
The organisation shall conduct internal audits at planned intervals to determine whether the quality management system
a) Conforms to the planned arrangements (see7.1) to the requirements of this International Standard and to the quality management system requirements established by the organisation, and
b) Is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined.
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Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
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8.2.2.1 Quality management system audit
The organisation shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.
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8.2.2.2 Manufacturing process audit
The organisation shall audit each manufacturing process to determine its effectiveness.
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8.2.2.3 Product audit
The organisation shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging, labeling, at a defined frequency.
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8.2.2.4 Internal audit plans
Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.
When internal / external non conformities or customer complaints occur, the audit frequency shall be appropriately increased.
NOTE Specific checklists should be used for each audit.
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8.2.2.5 Internal auditor qualification
The organisation shall have internal auditors who are qualified to audit the requirements of this Technical Specification (see 6.2.2.2).
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INTERNAL AUDIT
(ISO/TS 16949 – 2002)
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Auditing for conformance with planned arrangements
Planned Arrangements are the
agreed criteria and these are the
intentions of management as expressed
by the quality policy, quality objectives
and particular requirements for products.
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Clause 7.1 refers to clause 4.1 and therefore, the audit should verify that in designing the management system, the organization has identified all the necessary processes, determined their sequence and interaction, the criteria and methods for effective operation and control, provided the necessary information and resources and installed the necessary monitoring, measurement analysis and improvement processes.
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Planned intervals - Any time interval and as the quality policy is unlikely to change very much in a five-year period, annual audits may not detect any significant variations. Quality objectives also may change once a year and so quarterly audits may not detect any significant change. However, product requirements vary with every new product. Intervals of audit need to be set relative to changes in polices, objectives and products rather than a set frequency.
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The audits should be designed to verify that the system is capable of – Implementing the agreed policies (a
policy audit)Enabling the organization to achieve
the agreed objectives (a strategic audit)Enabling the organization to meet the
specific product requirements (a project or product audit).
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• Whom is it important – the customer, the managing director, the public or immediate superior ?
• Importance of the activity upon the effect of non-compliance with the planned arrangements.
• Minor decision in the planning or design phase could result in major problems.
Importance of the Process
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The audit criteria are the standards for the performance being audited. They may include policies, procedures, regulations or requirements The scope of the audit is a definition of what the audit is to cover including the areas, locations, shifts, processes, departments etc.
Defining audit criteria, scope, frequency and methods
Contd…..
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Selection of Auditors
Should be selected on the basis of their
objectivity and impartiality – such that their
association with the work being audited
should not influence their judgment.
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Auditors can be from the same department as the activities being audited, provided they do not perform the activities being audited.
Separate independent quality audit departments could be set staffed with trained auditors.
Audits could be carried out by competent personal at any level.
Retaining Impartiality
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Audit procedures
This means that the who, when, where, what,
why and the how of planning, conducting
and reporting audits should be defined and
documented. The methods of maintaining
audit records following the audit should also
be defined and documented
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The audit procedures should cover the following -Preparing the annual audit programme.The selection of auditors and team
leader if necessary.Planning particular type of audits.Conducting the audit.Recording observations.Determining corrective actions.Reporting audit findings.Implementing corrective actions.Confirming the effectiveness of
corrective actions.Contd…..
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The forms on which you plan the audit.The forms on which you record the
observations and corrective actions.Any warning notices you send out of
impending audits, overdue corrective actions and escalation actions.
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Audit Planning
The detail plan for each audit include
dates, what is to be audited, against what
requirements and by whom. Overall
plans are best presented as programme
chargs and detail plan as check lists.
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Although checklists may be considered a plan, in the context of an audit they should be considered only as an aid to allow the auditor to follow trails that may lead to discovery of pertinent facts. The checklist should represent minimum aspects indicating -• Those activities that were compliant• Those activities that did not comply.• Those activities that were not checked.• Those activities where there were
opportunities for improvement.
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Taking Action
Management responsible for the area audited are those who have the authority to cause change.
Action without undue delay means that management are expected to act before the detected problem impacts subsequent results.
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Eliminating non-conformities and their causes means that managers should –
• Take remedial action to correct the particular non-conformity.
• Search for other examples of non-conformity and establish how widespread the problem is.
• Establish the route cause of the non-conformity and prevent its recurrence.
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The auditor needs to be sure that a failure to act will in fact impact performance of the processes or the system.
Therefore, auditor to explain the impact of the detected non-conformity within the audit report – possibly by using a classification convention from critical to minor.
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Follow up AuditsAn action taken after the audit to verify that agreed actions from the audit have been completed as planned.
Follow-up audits may be carried out immediately after the planned completion date for the actions or at some other agreed time. However, unless the audit is carried out relatively close to the agreed completion date, it will not be possible to ascertain if the action was carried out without undue delay.
Contd…..
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The auditor who carries out the follow-up audit need not be the same that carried out the internal audit. In fact there is some merit in using different auditors in order to calibrate the auditors. When all the agreed non-conformities have been eliminated the audit report can be closed. The audit remains incomplete until all actions have been verified as being completed.
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Product Audit
• On-site verification activity used to –
• verify conformance to specified product requirements (e.g., design requirements, engineering specifications),
• ensure that quality objectives are met,• verify that these requirements are met.
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Manufacturing Process Audit• On-site verification activity used to –
• verify conformance to specified requirements, such as control plan, work instructions,
• ensure that quality objectives are met,• verify that specified requirements for
process capability/ performance are met,• assess the effectiveness of activities and
related results.
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63
ISO/TS 16949 – 2002
REQUIREMENTS AND
CHECKLISTS
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64
The organisation shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.The organisation shall
4. QUALITY MANAGEMENT SYSTEM
4.1 General requirements
a) identify the processes needed for the quality management system and their application throughout the organisation (see 1.2),
b) determine the sequence and interaction of these processes,
Contd.
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c) determine criteria and methods needed to ensure that both the operation and control of these process are effective.
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organisation in accordance with the requirements of this International Standard.
Contd.
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NOTE : Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realisation and measurement
Where an organisation chooses to outsource any process that affects product conformity with requirements, the organisation shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
Contd.
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Clause No 4.1 e & f Monitoring measuring and
analysing the processes and implementing actions necessary to achieve planned results and continual improvement of the processes.
ALL
Controlling of outsourced processes that can affect product conformity with requirements.
PM, DM, QA
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4.1.1 General Requirements - Supplemental
Ensuring control over outsourced processes shall not absolve the organisation of the responsibility of conformity to all customer requirements.
NOTE : See also 7.4.1 and 7.4.1.3
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4.2 Documentation requirements4.2.1 General
The quality management system documentation shall includea) documented statements of a quality policy and
quality objectives,b) a quality manual,c) documented procedures required by this
International Standard ,d) documents needed by the organisation to ensure
the effective planning, operation and control of its processes, and
e) records required by this International Standard(see 4.2.4).
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NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
NOTE 2 The extent of the quality management system documentation can differ from one organisation to another due to a) the size of organisation and type of activities,b) the complexity of processes and their interactions, andc) the competence of personnel.NOTE 3 The documentation can be in any form or type of medium.
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4.2.2 Quality manual
The organisation shall establish and maintain a quality manual that includesa) the scope of the quality management system, including the details of and justification for any exclusions (see 1.2),b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system.
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4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls neededa) to approve documents for adequacy prior to issue,b) to review and update as necessary and re-approve documents.c) to ensure that changes and the current revision status of documents are identified,d) to ensure that relevant versions of applicable documents are available at points of use,
Contd.
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e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
Contd.
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Clause No 4.2.3
List of controlled documents alongwith their latest revision status.
ALL
Issue record of documents
Availability of pertinent documents at its point of use.
Withdrawal of obsolete documents
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.
4.2.3.1 Engineering specificationsThe organisation shall have a process to assure the timely review, distribution and implementation of all customer engineering standards / specifications and changes based on customer required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks.
The organisation shall maintain a record of the date on which each change is implemented in production.
Implementation shall include updated documents.
NOTE A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.
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Clause No 4.2.3.1 Timely review, distribution and
implementation of all customer engineering standards/ specification and changes based on customer required schedule.
PED
Review should be as soon as possible and not exceeding two working weeks
PED
Record of the date on which each change is implemented in production including updating of documents.
PED
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4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
NOTE 1 “Disposition” above includes disposal.
NOTE 2 “Records” also include customer -specified records.
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Clause No 4.2.4
Legibility, readily identifiability and retrievability of records
ALL
Retaining updated record of customer production part approval (PPA) if the changes in the standards/ specifications effect PPA documents i.e., Control Plan, FMEA etc.
PED
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4.2.4.1 Records retention
The control of records shall satisfy regulatory and customer requirements.
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5 MANAGEMENT RESPONSIBILITY
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organisation the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews,and
e) ensuring the availability of resources.
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5.1.1 Process efficiency
Top management shall monitor the product realisation processes and the support processes to assure their effectiveness and efficiency.
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Clause No 5.1.1 Review by top management of
the product realisation processes and the support processes to assure their effectiveness and efficiency.
MR
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5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
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5.3 Quality policy
Top management shall ensure that the quality policya) is appropriate to the purpose of the organisation,b) includes a commitment to comply with requirements
and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organisation, and
e) is reviewed for continuing suitability.
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Clause No 5.3 Communication and understanding
of the quality policy within the organisation.
ALL
Reviewing of continuing suitability of Quality Policy.
MR
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5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a) are established at relevant functions and levels within the organisation. The quality objectives shall be measurable and consistent with the quality policy.
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Clause No 5.4.1 Establishment of quality
objectives at all levels.
ALL
Development of action plan and road map for each objective
Measuring, monitoring and analysing the results against the road map of each objectives and implementing actions necessary to achieve the planned results
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5.4.1.1 Quality objectives- supplemental
Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.
NOTE Quality objectives should address customer expectations and be achievable within a defined time period.
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5.4.2 Quality management systems planning
Top management shall ensure that a) the planning of the quality management system is
carried out in order to meet the requirements given in 4.1, as well as the quality objectives, andb) the integrity of the quality management system is
maintained when changes to the quality management system are planned and implemented.
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5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management shall ensure that the responsibilities and authorities are defined and communicated within the organisation.
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5.5.1.1 Responsibility for quality
Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.
Personnel responsible for product quality shall have the authority to stop production to correct quality problems.
Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.
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5.5.2 Management representativeTop management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement, and
c) ensuring the promotion of awareness of customer requirements throughout the organisation.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
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Clause No 5.5.2 Promoting of awareness of
customer requirement throughout the organisation.
MR
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5.5.2.1 Customer representative
Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.
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5.5.3 Internal communication
Top management shall ensure that appropriate communication processes are established within the organisation and that communication takes place regarding the effectiveness of the quality management system.
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5.6 Management review5.6.1 General
Top management shall review the organisation’s quality management system, at planned intervals, to ensure its continuing suitability,adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
Records from management reviews shall be maintained (see 4.2.4).
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Clause No 5.6.1 Maintaining records from
management review MR
Management review includes all requirements of the Quality Management System and its performance trends
MR
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5.6.1.1 Quality management system performance
These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process.Part of the management reviews shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality(see 8.4.1 and 8.5.1).These results shall be recorded to provide, as a minimum, evidence of the achievement of - the quality objectives specified in the buisness plan, and- customer satisfaction with product supplied.
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Clause No 5.6.1.1 Recording the results of review
of customer satisfaction of the product
MR
Part of the management review includes :
MR
o monitoring of quality objectives.o regular reporting and evaluation of
the cost of the poor quality.o quality objectives specified in the
Business Plan.o customer satisfaction with product
supplied :
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5.6.2 Review input
The input to management review shall include information ona) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement.
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5.6.2.1 Review input- Supplemental
Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment.
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Clause No 5.6.2 and 5.6.2.1 Management review includes : MR
o Results of audits o Customer feedbacko Process performance and product
conformity.o Status of preventive and corrective
action o Follow up actions previous management
reviees.o Changes that could effect the quality
management system.o Recommendation for improvement.o Analysis of actual and potential field
failures and their impact on quality, safety or the environment.
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5.6.3 Review output
The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
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Clause No 5.6.3 The management review output
includes : MR
o improvement of the effectiveness of the quality management system and its processes.
o improvement of product related to customer requirements, and
o resource needs.
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6 RESOURCE MANAGEMENT
6.1 Provision of resources
The organisation shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
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6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
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Clause No 6.2.1 The personnel performing work
effecting product quality are competent on the basis of appropriate education, training, skills and experience.
ALL
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6.2.2 Competence, awareness and training
The organisation shall a) determine the necessary competence for personnel
performing work affecting product quality,b) provide training or take other actions to satisfy
these needs,c) evaluate the effectiveness of the actions taken,d) ensure that its personnel are aware of the relevance
and importance of their activities and how they contribute to the achievements of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
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Clause No 6.2.2 Determining the necessary competence
for personnel performing work affecting product quality
HRD
• Providing training or taking other actions to satisfy the competency needs.
HRD
• Evaluating the effectiveness of the training and other actions taken.
HRD
• Ensuring that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
ALL
• Maintaining records of education, training, skills and experience.
HRD
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6.2.2.1 Product design skills
The organisation shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.
Applicable tools and techniques shall be identified by the organisation.
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6.2.2.2 Training
The organisation shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements..
NOTE 1 This applies to all employees having an affect on quality at all levels of the organisation.
NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.
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Clause No 6.2.2.2 Identifying training needs and
achieving competence of all personnel performing activities affecting product quality
HRD
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6.2.2.3 Training on the job
The organisation shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.
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Clause No 6.2.2.3 Providing on the job training for
personnel in any new or modified job affecting the product quality including contract or agency personnel.
ALL Informing personnel whose
work could affect quality about the consequences to the customer of non conformity to quality requirements
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6.2.2.4 Employee motivation and empowerment
The organisation shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness througout the whole organisation.
The organisation shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (See 6.2.2 d).
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Clause No 6.2.2.4 • Motivating employees to achieve
quality objectives, to make continual improvements ; and to create an environment to promote innovation.
ALL
• Promoting quality and technological awareness throughout the whole organisation
• Measuring the extent to which personnel are aware of their relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
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6.3 Infrastructure
The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) building, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).
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6.3.1 Plant, facility and equipment planning
The organisation shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.
NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.
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Clause No 6.3.1 Using multi disciplinary
approach for developing plant facility and equipment plans.
PED
Evaluating and monitoring the effectiveness of existing operations
PED
Optimising material flow, handling and value added use of floor space and facilitating synchronous material flow of plant layouts
PED
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6.3.2 Contingency plans
The organisation shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.
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Clause No. 6.3.2 Multi skilling of personnel ALL
Stocking of spares of key equipment and monitoring their inventory levels
PM, DM
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6.4 Work environment
The organisation shall determine and manage the work environment needed to achieve conformity to product requirements.
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Clause No. 6.4 Managing work environment
needed to achieve conformity to product requirements.
WS, PS, MFG., LC, MX, PM, QA, DM
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6.4.1 Personnel safety
Product safety and means to minimize potential risks to employees shall be addressed by the organisation, especially in the design and development process and in manufacturing process activities.
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Clause No. 6.4.1 Minimising potential risks to
employees in process design and development process and manufacturing process activities
PED, WS, PS, MFG., MX, PM, QA, QM,
LC
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6.4.2 Cleanliness of premises
The organisation shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.
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Clause No. 6.4.2 Maintaining premises in a state
of order, cleanliness and repair consistent with the product and manufacturing process needs.
WS, PS, MFG.,
MX, PM, QA, DM,
LC
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7 PRODUCT realisation7.1 Planning of product realisation
The organisation shall plan and develop the processes needed for product realisation. Planning of product realisation shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realisation, the organisation shall determine the following, as appropriate:
Contd.
a) quality objectives and requirements for the product,
b) the need to establish processes, documents, and provide resources specific to the product,
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c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realisation processes and resulting product meet requirements(see 4.2.4).
The output of this planning shall be in a form suitable for the organisation’s method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realisation processes) and the resources to be applied to a specific product,project or contract,can be referred to as a quality plan.
Contd.
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NOTE 2 The organisation may also apply the requirements given in 7.3 to the development of product realisation processes.
NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realisation. Advanced product quality planning embodies the concept of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach.
Contd.
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7.1.1 Planning of product realisation - SupplementalCustomer requirements and references to its technical specifications shall be included in the planning of product realisation as a component of the quality plan.
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7.1.2 Acceptance criteria
Acceptance criteria shall be defined by the organisation and, where required, approved by the customer.
For attribute data sampling, acceptance criteria shall be zero defects (see 8.2.3.1).
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7.1.3 Confidentiality
The organisation shall ensure the confidentiality of customer-contracted products and projects under development, and related product information.
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Clause No 7.1, 7.1.1 and 7.1.3Planning the product realisation. PED
o Determining the following as appropriate quality objectives and requirements for the
product the need to establish processes, documents
and resources specific to product. required verification, validation, monitoring,
inspection and test activities specific to the product and the criteria for product acceptance.
records needed to provide evidence that the realisation processes and resulting product meet requirements
o including customer requirements and referencing to its technical specifications as a component of the quality plan.
Contd….
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Contd….
o defining the acceptance criteria. o ensuring confidentiality of customer –
contracted product and projects under development, and related product information.
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7.1.4 Change control
The organisation shall have a process to control and react to changes that impact product realisation. The effects of any change, including those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be validated before implementation.
For proprietary designs, impact on form, fit and function (including performance, and / or durability) shall be reviewed with the customer so that all effects can be properly evaluated.
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When required by the customer, additional verification / identification requirements, such as those required for new product introduction, shall be met.
Note 1 Any product realisation change affecting customer requirements requires notification to, and agreement from, the customer.
Note 2 The above requirement applies to product and manufacturing process changes.
Contd.
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Clause No. 7.1.4 Controlling, reacting to and
validation of changes that impact product realisation before implementation.
PED
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7.2 Customer- related processes7.2.1 Determination of requirements related to the
product.The organisation shall determinea) requirements specified by the customer, including
the requirements for delivery and post delivery activities.
b) requirements not stated by the customer but necessary for specified or intended use, where known.
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organisation.
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Note 1 Post delivery activities include any after sales product service provided as part of the customer contract or purchase order.
Note 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organisation’s knowledge of the product and manufacturing processes(see 7.3.2.3).
Note 3 Compliance to items c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.
Contd.
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Clause No 7.2.1Determination of requirements
related to the product including PED
o requirements specified by the customer, including the requirement for delivery and post delivery activities.
o requirements not stated by the customer but necessary for specified or intended use where known.
o statutory and regulatory requirements related to the product, and
o any additional requirements determined by the organisation.
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7.2.1.1 Customer designated special characteristics
The organisation shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.
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Clause No. 7.2.1.1 Designating, documentation
and control of special characteristics.
PED
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7.2.2 Review of requirements related to the productThe organisation shall review the requirements related to the product. This review shall be conducted prior to the organisation’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure thata) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organisation has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
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Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organisation before acceptance.
Where product requirements are changed, the organisation shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
NOTE In some situations, such as internal sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
Contd.
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Clause No. 7.2.2 Reviewing requirements related
to the product as per procedure. PED, BD
Recording results of such reviews.
PED, BD
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7.2.2.1 Review of requirements related to the produuct - Supplemental
Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorisation..
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7.2.2.2 Organisation manufacturing feasibility
The organisation shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.
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Clause No. 7.2.2.2 Investigating, conforming and
documenting the manufacturing feasibility including risk analysis, as per procedure.
PED, BD
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7.2.3 Customer communication
The organisation shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
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Clause No. 7.2.3 Determining and implementing
effective arrangements for communication with customers, as per procedure.
PED, BD
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7.2.3.1 Customer communication – Supplemental
The organisation shall have the ability to communicate necessary information, including data, in a customer -specified language and format (e.g. computer-aided design data, electronic data exchange).
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7.3 Design and development
NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.
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7.3.1 Design and development planningThe organisation shall plan and control the design and development of product.During the design and development planning, the organisation shall determine
a) the design and development stages,b) the review, verification and validation that are
appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.The organisation shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.Planning output shall be updated, as appropriate, as the design and development progresses.
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Clause No. 7.3.1 Planning and controlling the
process design and development of product, as per procedure.
PED, BD
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7.3.1.1 Multidisciplinary approach
The organisation shall use a multidisciplinary approach to prepare for product realisation, including- development / finalization and monitoring of special
characteristics,
- development and review of FMEAs including actions to reduce potential risks, and
- development and review of control plans.
NOTE A multidisciplinary approach typically includes the organisation’s design, manufacturing, engineering, quality, production and other appropriate personnel.
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Clause No 7.3.1.1Using multi disciplinary approach
for : PED
o finalisation and monitoring of special characteristics.
o development and review of FMEAs. o development and review of control plans.
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7.3.2 Design and development inputsInputs relating to product requirements shall be determined and records maintained (see 4.2.4).These inputs shall includea) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
NOTE Special characteristics (see 7.2.1.1) are included in this requirement.
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7.3.2.1 Product design input
The organisation shall identify, document and review the product design inputs requirements, including the following :- Customer requirements (contract review) such as
special characteristics (see 7.3.2.3), identification, traceability and packaging;
- Use of information; the organisation shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature;
- Targets for product quality, life, reliability, durability, maintainability, timing and cost.
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7.3.2.2 Manufacturing process design input
The organisation shall identify, document and review the manufacturing process design input requirements, including
- product design output data,
- targets for productivity, process capability and cost,
- customers requirements, if any, and
- experience from previous developments.
NOTE The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.
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7.3.2.3 Special characteristics
The organisation shall identify special characteristics (see 7.3.3 d) and- include all special characteristics in the control
plan,
- comply with customer specified definitions and symbols, and
- identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the organisation’s equivalent symbol or notation to include those process steps that affect special characteristics.
NOTE Special characteristics can include product characteristics and process parameters.
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Clause No 7.3.2, 7.3.2.2 and 7.3.2.3Determining and maintaining
records of the inputs relating to product requirements, including :
PED
o functional & performance requirements. o applicable statutory and regulatory
requirements. o process design output data. o targets for productivity, process
capability and cost o customer requirements, if any o experience from previous developments.
Contd….
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Reviewing the adequacy of the inputs.
PED
Identifying special characteristics. PED
Contd….
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7.3.3 Design and development outputThe outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
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7.3.3.1 Product design outputs - Supplemental
The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include
- design FMEA, reliability results,
- product special characteristics and specifications,
- product error-proofing, as appropriate,
- product definition including drawings or mathematically based data,
- product design reviews results, and
- diagnostic guidelines where applicable.
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7.3.3.2 Manufacturing process design outputThe manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include - specifications and drawings, - manufacturing process flow chart / layout, - manufacturing process FMEAs, - control plan (see 7.5.1.1), - work instructions, - process approval acceptance criteria, - data for quality, reliability, maintainability and measurability, - results of error-proofing activities, as appropriate, and - methods of rapid detection and feedback of product / manufacturing process nonconformities.
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Clause No 7.3.3 and 7.3.3.2 Providing process design and
development output including PED
o meeting the input requirements for process design and development.
o providing information for purchasing and production.
o referencing product acceptance criteria. o specifying the characteristics of the
product that are essential for its safe and proper use.
o specifications and drawings. o manufacturing process flow chart.
Contd….
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o manufacturing process FMEA. o control plan. o work instructions. o process approval acceptance criteria. o data for quality, reliability, maintainability
and measurability o results and error proofing activities and o methods of rapid detection and feed back
of product/ manufacturing process non conformities.
Contd….
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7.3.4 Design and development reviewAt suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)a) to evaluate the ability of the results of design and
development to meet requirements, and
b) to identify any problems and propose necessary actions,
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4)
NOTE These reviews are normally coordinated with the design phases and should includes manufacturing process design and development
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Systematic reviews of process design and development at suitable stages in accordance with planned arrangements.
PED
Records of results of process design and development reviews and any necessary actions.
PED
Clause No 7.3.4
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7.3.4.1 Monitoring
Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review.
NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.
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Defining, analysing and reporting with summary results as an input to management review of measurement at specified stages of process design and development.
PEDClause No 7.3.4.1
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7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
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Verifying the process design and development in accordance with the planned arrangements to ensure that the process design and development output have met the process design and development input requirements..
PED
Recording of the results of verification and any necessary action taken of the process design and development.
PED
Clause No 7.3.5
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7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).NOTE 1. The validation process normally includes an analysis of field reports for similar products.NOTE 2. The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.
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Validation of process design and development in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
PED
Recording the results of validation and any actions taken of process design and development.
PED
Clause No 7.3.6
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7.3.6.1 Design and development validation - Supplemental
Design and development validation shall be performed in accordance with customer requirements including programme timing.
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Validation of process design and development in accordance with customer requirement including programme timing.
PEDClause No 7.3.6.1
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7.3.6.2 Prototype programme
When required by the customer, the organisation shall have a prototype programme and control plan. The organisation shall use, wherever possible, the same suppliers, tooling and manufacturing processes as will be used in production.
All performance testing activities shall be monitored for timely completion and conformity to requirements.
While services may be outsourced, the organisation shall be responsible for the outsourced services, including technical leadership .
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7.3.6.3 Product approval process
The organisation shall conform to a product and manufacturing process approval procedure recognised by the customer.
NOTE Product approval should be subsequent to the verification of the manufacturing process.
This product and manufacturing process approval procedure shall also be applied to suppliers.
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Product and manufacturing process approval as recognised by the customer.
PED
Product and manufacturing process approval of suppliers.
PED
Clause No 7.3.6.3
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7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
NOTE Design and development changes include all changes during the product programme life(see 7.1.4).
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Identifying and recording process design and development changes
PED
Reviewing, verifying and validating the changes before implementing during process designing and development.
PED
Recording the results of the review of changes and any necessary action during process designing and development.
PED
Clause No 7.3.7
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7.4 Purchasing 7.4.1 Purchasing processThe organisation shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final product.
The organisation shall evaluate and select suppliers based on their ability to supply products in accordance with the organisation’s requirements. Criteria for selection, evaluation, and re-evaluation shall be established. Records of the results o evaluations and any necessary actions arising from the evaluation shall be maintained. (see 4.2.4)
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NOTE 1 Purchased products above include all products and services that affect customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services.
NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organisation should verify the continuity of the supplier’s quality management system and its effectiveness.
Contd.
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Records of the results of evaluation and any necessary action arising from the evaluation of the suppliers.
PUR, RML, BOP, QA
Clause No 7.4.1
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7.4.1.1 Regulatory compliance
All purchased products or materials used in product shall conform to applicable regulatory requirements.
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Ensuring all purchased products or materials used in product conform to applicable regulatory requirements.
PUR, RML, BOP
Clause No 7.4.1.1
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7.4.1.2 Supplier quality management system developmentThe organisation shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is the first step in achieving this goal.NOTE The prioritisation of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied.Unless otherwise specified by the customer, suppliers to the organisation shall be third party registered to ISO 9001:2000 by an accredited third party certification body.
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Performing supplier quality management system development with the goal of supplier conformity with ISO/TS 16949 : 2002.
QA, PUR, RML, BOP
Suppliers are third party registered to ISO 9001 : 2002 by an accredited third party certification body.
QA, PUR, RML, BOP
Clause No 7.4.1.2
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7.4.1.3 Customer approved sources
Where specified by the contract (e.g. customer engineering drawing, specification), the organisation shall purchase products, materials or services from approved sources.
The use of customer designated sources, including tool / gauge suppliers, does not relieve the organisation of the responsibility for ensuring the quality of purchased products.
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Purchasing products, materials or services from sources approved by the customer where specified by contract such as customer engineering drawing, specifications etc.
PUR, RML, BOP, PED
Clause No 7.4.1.3
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7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organisation shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
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Clause No 7.4.2Purchasing information describe
the product to be purchased, including where appropriate
PUR, BOP, RML, PED
o requirements for approval of product, procedures and equipment.
o requirements for qualification of personnel.
o quality management system requirements.
Adequacy of specified product requirements prior to their communication to the supplier.
PUR, RML, BOP, PED
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7.4.3 Verification of purchased product
The organisation shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where the organisation or its customer intends to perform verification at the supplier’s premises, the organisation shall state the intended verification arrangements and method of product release in the purchasing information.
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7.4.3.1 Incoming product quality
The organisation shall have a process to assure the quality of purchased product (see 7.4.3) utilising one or more of the following methods:- receipt of, and evaluation of, statistical data by the
organisation;
- receiving inspection and / or testing such as sampling based on performance;
- second or third party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality;
- part evaluation by a designated laboratory;
- another method agreed with the customer.
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Clause No 7.4.3.1 Receiving inspection as per laid
down procedures. QA
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7.4.3.2 Supplier monitoring
Supplier performance shall be monitored through the following indicators:- delivered product quality,
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight),
- special status customer notifications related to quality or delivery issues.
The organisation shall promote supplier monitoring of the performance of their manufacturing processes.
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Monitoring of supplier performance including product quality, customer disruptions, delivery and special status customer notifications related to quality or delivery issues.
PUR, RML, SC
Promoting supplier monitoring of the performance of their processes
PUR, RML,
SC, QA
Clause No 7.4.3.2
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7.5 Production and service provision7.5.1 Control of production and services provision.The organisation shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicablea) the availability of information that describes the characteristics of the product,b) the availability of work instructions, as necessary,c) the use of suitable equipment,d) the availability and use of monitoring and measuring devices,e) the implementation of monitoring and measurement, andf) the implementation of release, delivery and post- delivery activities.
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Clause No 7.5.1Carrying out production under
controlled conditions, including : PS, WS,
MFG., LC
o availability of information that describes the characteristics of the product.
o availability of the work instructions o use of suitable equipment o availability and use of monitoring and
measuring devices o implementation of monitoring and
measurement o implementation of release, delivery and
post delivery activities.
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7.5.1.1 Control planThe organisation shall- develop control plans (see Annex A) at the system,
sub system, component and / or material level for the product supplied, including those for processes producing bulk materials as well as parts, and
- have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs,
The control plan shall- list the controls used for the manufacturing process control,
Contd.
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- include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organisation,
- include the customer required information, if any, and
- initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable.Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources of FMEA (see 7.1.4).NOTE Customer approval may be required after review or update of the control plan.
Contd.
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Control plan, including initiating the specified reaction plan when the process becomes unstable or not statistically capable.
PED
Reviewing and updating control plans when any change occurs effecting product, manufacturing process, measurement, logistics, supplier sources or FMEA.
PED, PS, WS, MFG.,
LC, MX, QA, QAS,
RML, PUR, BOP, SC
Clause No 7.5.1.1
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7.5.1.2 Work instructions
The organisation shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality. These instructions shall be accessible for use at the work station.
These instructions shall be derived from sources such as the quality plan, the control plan and the product realisation process.
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Documented work instructions for employees having responsibilities for the operation of processes that impact product quality.
WS, PS, MFG., LC, MX, QA, PM, DM
Accessibility of these work instructions for use at work station.
Clause No 7.5.1.2
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7.5.1.3 Verification of job set-ups
Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover, job change.
Work instructions shall be available for set-up personnel. The organisation shall use statistical methods of verification where applicable.
NOTE Last off- part comparisons are recommended.
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Verification of job set up as per laid down procedure
PS, WS, MFG., LC
Availability of work instructions for set up personnel.
PS, WS, MFG., LC
Use of statistical methods for verification of job set ups where applicable
PS, WS, MFG., LC
Clause No 7.5.1.3
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7.5.1.4 Preventive and predictive maintenanceThe organisation shall identify key process equipment and provide resources for machine / equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following:- planned maintenance activities,
- packaging and preservation of equipment, tooling and gauging,
- availability of replacement parts for key manufacturing equipment,
- documenting, evaluating and improving maintenance objectives.
The organisation shall utilise predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment.
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Following preventive and predictive maintenance procedure
PM
Preventive maintenance plan PM
Implementing preventive maintenance plan.
PM
Packaging and preservation of equipment, tooling and gauging
PM, DM, QA
Availability of replacement parts for key manufacturing equipment
PM
Clause No 7.5.1.4
Contd….
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Documentation, evaluation and improving maintenance objectives
PM
Utilising predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipments
PM
Contd….
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7.5.1.5 Management of production tooling
The organisation shall provide resources for tool and gauge design, fabrication and verification activities.
The organisation shall establish and implement a system for production tooling management including:
Contd.
- maintenance and repair facilities and personnel,
- storage and recovery,
- set-up,
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- tool-change programmes for perishable tools,- tool design modification documentation, including
engineering change level,- tool modification and revision to documentation,- tool identification, defining the status, such as
production, repair or disposal.The organisation shall implement a system to monitor these activities if any work is outsourced.NOTE This requirement also applies to the availability of tools for vehicle service parts.
Contd.
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Following tooling maintenance procedure.
DM
Tooling maintenance plan DM
Implementing tooling maintenance plans
DM
Tool change programme for perishable tools
DM
Documentation of changes/ modification in tool design
DM
Clause No 7.5.1.5
Contd….
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Revision to documentation when modification in tools is carried out
DM
Identification of tools including status such as production, repair or disposal
DM
Contd….
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7.5.1.6 Production scheduling
Production shall be scheduled in order to meet customer requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven.
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Following the production planning procedure.
MX, WS, PS, MFG.,
LC
Clause No 7.5.1.6
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7.5.1.7 Feedback of information from service
A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained.
NOTE The intent of the addition of “service concerns” to this sub-clause is to ensure that the organisation is aware of non-conformities that occur external to its organisation.
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7.5.1.8 Servicing agreement with customer
When there is a servicing agreement with the customer,the organisation shall verify the effectiveness of - any organisation service centers,- any special purpose tools or measurement equipment, and- the training of service personnel.
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7.5.2 Validation of processes for production and service provision
The organisation shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organisation shall establish arrangements for these processes including, as applicable
Contd.
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a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirement for records (see 4.2.4), and
e) revalidation.
Contd.
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Clause No 7.5.2Validation of all processes to
demonstrate ability of these processes to achieve planned results, including :
WS, PS, MFG., LC
o defined criteria for review and approval of the process
o approval of equipment and qualification of personnel
o use of specific methods and procedures
o requirement of records o revalidation
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7.5.2.1 Validation of processes for production and service provision-supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.
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7.5.3 Identification and traceability
Where appropriate, the organisation shall identify the product by suitable means throughout product realisation.
The organisation shall identify the product status with respect to monitoring and measurement requirements.
Where traceability is a requirement, the organisation shall control and record the unique identification of the product (see 4.2.4).
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NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
NOTE inspection and test status is not indicated by the location of product in the production flow unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented, and achieves the designated purpose.
Contd.
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7.5.3.1 Identification and traceability-supplemental
The words “where appropriate” in 7.5.3 above, shall not apply.
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7.5.4 Customer property
The organisation shall exercise care with customer property while it is under the organisation’s control or being used by the organisation. The organisation shall identify,verify,protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4)
NOTE Customer property can include intellectual property.
NOTE Customer-owned returnable packaging is included in this clause.
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Clause No 7.5.4Identifying, verifying, protecting
and safe guarding customer property.
MX, DM, PED
Reporting to the customer and maintaining record of any customer property which is lost, damaged or otherwise found to be unsuitable for use.
MX, DM, PED
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7.5.4.1 Customer owned production tooling
Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined.
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Clause No 7.5.4.1 Permanently marking the
ownership of customer owned tooling.
DM
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7.5.5 Preservation of product
The organisation shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
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Clause No 7.5.5Identification, handling,
packaging, storage and protection of product during internal processing and delivery.
MX
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7.5.5.1 Storage and inventory
In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.
The organisation shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as “first in first out” (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product.
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Clause No 7.5.5.1 Assessing the condition of
product in stock at planned intervals to detect deterioration.
MX
Optimising inventory turns MX
First In First Out MX
Controlling obsolete products in a similar manner to non conforming products
MX
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7.6 Control of monitoring and measuring devices
The organisation shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
The organisation shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall
Contd.
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a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
Contd.
Contd.
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In addition, the organisation shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organisation shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c ) above.
Contd.
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Clause No 7.6 Control of monitoring and
measurement devices as per procedure
QA
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7.6.1 Measurement system analysis
Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer.
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Clause No 7.6.1 Measurement system analysis to
analyse the variation present in each type of measurement and test equipment, as per procedure.
QA
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7.6.2 Calibration /verificationrecords
Records of the calibration/ verification activity for all gauges, measuring and test equipment, needing to provide evidence of conformity of product to determined requirements, including employee and customer-owned equipment, shall include- equipment identification, including the measurement standard against which the equipment is calibrated,- revisions following engineering changes,- any out-of-specification readings as received for calibration / verification,- an assessment of the impact of out-of-specification condition,- statements of conformity to specification after calibration / verification, and- notification to the customer if suspect product or material has been shipped.
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Clause No 7.6.2Records of calibration/ verification
for all gauges, measurement and test equipment, including :
QA
o equipment identification. o revisions following engineering changes o any out of specification readings as
received for calibration/ verification. o an assessment of out of specification
condition o statement of conformity to specifications
after calibration o notification to the customer if suspected
product or material has been shipped
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7.6.3 Laboratory requirements
7.6.3.1 Internal laboratory
An organisation’s internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall and implement, as a minimum, technical requirements for
Contd.
- adequacy of the laboratory procedures,
- competency of the laboratory personnel,
- testing of the product,
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- capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN etc.), and
- review of the related records.
NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory.
Contd.
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Clause No 7.6.3.1 Internal laboratory facility as per
laid down procedures. QA
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7.6.3.2 External laboratory
External / commercial / independent laboratory facilities used for inspection, test or calibration services by the organisation shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either
Contd.
- there shall be evidence that the external laboratory is acceptable to the customer, or.
- the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.
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NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.
NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organisation should ensure that the requirements listed in 7.6.3.1 have been met.
Contd.
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Clause No 7.6.3.2 Use of external laboratory facility
in line with the procedure QA
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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT8.1 General
The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
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Clause No 8.1Planning and implementing
the monitoring, measurement, analysis and improvement processes needed :
PS, DM, WS, MFG., LC, PM, QA, MX, PED,
PUR, RML, BOP, HRD, QAS
o to demonstrate conformity of the product
o to ensure conformity of the quality management system
o to continually improve the effectiveness of the quality management system.
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8.1.1 Identification of statistical tools
Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.
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Clause No 8.1.1Determining appropriate statistical
tools for each process during advance quality planning and their inclusion in the control plan.
PED
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8.1.2 Knowledge of basic statistical concepts
Basic statistical concepts, such as variation, control (stability), process capability and over adjustment shall be understood and utilised throughout the organisation..
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Clause No 8.1.2 Understanding the basic
statistical concepts throughout the organisation.
HRD
Utilising the statistical concept throughout the organisation.
PS, DM, WS, MFG.,
LC, PM, QA, MX,
PED
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8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, the organisation shall monitor information relating to customer perception as to whether the organisation has met customer requirements. The methods for obtaining and using this information shall be determined.
NOTE Consideration should be given to both internal and external customers.
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Clause No 8.2.1Monitoring customer satisfaction through information relating to customer perception as to whether the organisation meet customer requirements, as per procedure
MR
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8.2.1.1 Customer satisfaction-supplemental
Customer satisfaction with the organisation shall be monitored through continual evaluation of performance of the realisation processes. Performance indicators shall be based on objective data and include, but not be limited to:
- delivered part quality performance,
- customer disruptions including field returns,
- delivery schedule performance (including incidents of premium freight), and
- customer notifications related to quality or delivery issues.The organisation shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.
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Clause No 8.2.1.1Monitoring customer satisfaction through continual evaluation of performance of the realisation processes, as per procedure.
MR
Monitoring performance of manufacturing processes to demonstrate compliance to customer requirements for product quality and efficiency of the process.
PS, WS, MFG., LC
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8.2.2 Internal audit
The organisation shall conduct internal audits at planned intervals to determine whether the quality management system
a) Conforms to the planned arrangements (see7.1) to the requirements of this International Standard and to the quality management system requirements established by the organisation, and
b) Is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined.
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Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
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Clause No 8.2.2. Conducting internal audits at planned intervals
MR
Planning of internal audits considering the status and importance of the processes and areas to be audited as well as results of previous audits
MR
Defining audit criteria, scope, frequency and methods.
MR
Selection of internal auditors and conduct of audits ensures objectivity and impartiability of the audit process
MR
Contd….
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Records of internal audits MR
Taking actions without undue delay to eliminate detected non conformities during internal audit and their causes.
ALL
Verification of the actions taken and the reporting of verification results during follow up activities of the internal audits.
MR
Contd….
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8.2.2.1 Quality management system audit
The organisation shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.
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8.2.2.2 Manufacturing process audit
The organisation shall audit each manufacturing process to determine its effectiveness.
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Auditing of each manufacturing process to determine its effectiveness
MR Clause No 8.2.2.2
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8.2.2.3 Product audit
The organisation shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging, labeling, at a defined frequency.
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Auditing products at appropriate stages of production and delivery, at a defined frequency.
MR Clause No 8.2.2.3
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8.2.2.4 Internal audit plans
Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.
When internal / external non conformities or customer complaints occur, the audit frequency shall be appropriately increased.
NOTE Specific checklists should be used for each audit.
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Clause No 8.2.2.4 Internal audits cover all quality
management related processes, activities and shifts.
MR
Scheduling the internal audits according to the annual plan.
MR
Appropriately increasing the frequency of internal audit when internal / external non conformities or customer complaint occur
MR
Using specific check lists for each internal audit
MR
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8.2.2.5 Internal auditor qualification
The organisation shall have internal auditors who are qualified to audit the requirements of this Technical Specification (see 6.2.2.2).
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Clause No 8.2.2.5 Qualification of internal auditor. MR
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8.2.3 Monitoring and measurement of processes
The organisation shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken,as appropriate, to ensure conformity of the product.
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8.2.3.1 Monitoring and measurement of manufacturing processes
The organisation shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instruction. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.
Contd.
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The organisation shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organisation shall ensure that the control plan and process flow diagram are implemented, including, adherence to the specified
- measurement techniques,
- sampling plans,
- acceptance criteria, and
- reaction plans when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded.
Contd.
Contd.
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The organisation shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organisation, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.
The organisation shall maintain records of effective dates of process changes.
Contd.
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Clause No 8.2.3.1 Performing process studies on all
new manufacturing processes to verify process capabilities and to provide additional input for process control.
PED
Documenting results of above mentioned process studies including objectives for manufacturing process capability, reliability, maintainability, availability and acceptance criteria.
PED
Contd….
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Specify, all process capability or performance requirement as defined by the customer part approval requirements, in the JBPS or other manufacturing process, standard/ work instructions as ncessaary.
PED
Maintaining manufacturing process capability or performance as specified by PED in JBPS or other manufacturing process standard/ work instruction.
PS, WS, MFG.,
LC
Contd….
Contd….
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Include all requirement of control plan and process flow diagram in JBPS or other manufacturing process standard/ work instruction, including :
PED
o measurement technique o sampling plan o acceptance criteria o reaction plan when acceptance criteria
are not met
Recording significant process events
PS, WS,
MFG., LC
Contd….
Contd….
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Contd….
Initiating a reaction plan for characteristics that are either not statistically capable or are unstable, including containment of product and 100% inspection, as appropriate.
PS, WS, MFG.,
LC
Taking corrective action to assure that the process becomes stable and capable
PS, WS, MFG.,
LC
Maintaining records of effective dates of process changes
PS, WS, MFG.,
LC
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8.2.4 Monitoring and measurement of product
The organisation shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realisation process in accordance with the planned arrangements (see 7.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorising release of product (see4.2.4).
Product release and service delivery shall not proceed until all the planned arrangements (see7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer.
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NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organisation determines the types of product characteristics, leading to
- the types of measurement,
- suitable measurement means, and
- the capability and skills required.
Contd.
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In process and final verification/ inspection of products as per procedure.
QA, MX, PS,
MFG, WS, LC
Maintaining evidence of conformity of product with the acceptance criteria.
Records indicating the persons authorising release of products
Clause No 8.2.4
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8.2.4.1 Layout inspection and functional testing
A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review.
NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records.
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Clause No 8.2.4.1 Layout inspection and functional
verification for each product as specified in the control plan.
QA
Records of results of layout inspection.
QA
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8.2.4.2 Appearance items
For organisation manufacturing parts designated by the customer as “appearance items”, the organisation shall provide
- appropriate resources including lighting for evaluation,
- masters for color, grain, gloss, metallic, brilliance, texture, distinctness of image (DOI) as appropriate,
- maintenance and control of appearance masters and evaluation equipment, and
- verification that personnel making appearance evaluations are competent and qualified to do so.
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Providing : o appropriate lighting for evaluation o appearance masters
QA, PS,
MFG., WS, LC
o verification of personnel carrying out evaluation
for appearance items
Clause No 8.2.4.2
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8.3 Control of nonconforming productThe organisation shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organisation shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorising its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application.
Contd.
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Records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
When nonconforming product is detected after delivery or use has started, the organisation shall take action appropriate to effects, or potential effects, of the nonconformity.
Contd.
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Control of non conforming products
PS, WS, MFG, QA,
MX, LC
Records of the nature of non conformities and any subsequent actions taken, including concessions obtained.
Reverification after rework.
Clause No 8.3
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8.3.1 Control of nonconforming product - supplemental
Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).
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8.3.2 Control of reworked product
Instructions for rework, including re-inspection requirements, shall be accessible to and utilised by the appropriate personnel.
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Clause No 8.3.2 Accessibility and utlising
instructions for rework including reinspection.
PS, WS, MFG.,
MX, LC
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8.3.3 Customer information
Customers shall be informed promptly in the event that nonconforming product has been shipped.
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8.3.4 Customer waiver
The organisation shall obtain customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.
The organisation shall maintain a record of the expiration date or quantity authorised. The organisation shall also ensure compliance with the original or superseding specifications and requirements when the authorisation expires. Material shipped on an authorisation shall be properly identified on each shipping container.
This applies equally to purchased product. The organisation shall agree with any requests from suppliers before submission to customer.
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8.4 Analysis of data
The organisation shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1),
b) conformance to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.
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Comparing the trends in quality and operational performance with progress towards objectives and leading to action to support the following :
ALL
o development of priorities to prompt solutions to customer related problems
o determining key customer related trends and correlation for status review, decision making and longer term planning.
Clause No 8.4
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8.4.1 Analysis and use of data
Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following:
- development of priorities for prompt solutions to customer-related problems,
- determination of key customer-related trends and correlation to support status review, decision making and longer term planning,
- an information system for the timely reporting of product information arising from usage.
NOTE Data should be compared with those of competitors and / or appropriate benchmarks.
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Clause No 8.4.1 Obtaining customer concession
or deviation permit prior to further processing wherever the product or manufacturing process is different from that which is currently approved.
PS, WS, MFG, QA,
LC
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8.5 Improvement
8.5.1 Continual improvement
The organisation shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit result, analysis of data, corrective and preventive actions and management review.
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Clause No 8.5 and 8.5.1 Identifying and implementing
continually the continual improvement projects for meeting the action plans to achieve department objectives
ALL
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8.5.1.1 Continual improvement of the organisation
The organisation shall define a process for continual improvement (see examples in annex B of ISO 9004 : 2000).
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8.5.1.2 Manufacturing process improvement
Manufacturing Process improvement shall continually focus upon control and reduction of variation in products characteristics and manufacturing process parameters.
NOTE 1 Controlled characteristics are documented in the control plan.
NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.
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Clause No 8.5.1.2• Continually improving manufacturing
processes to control and reduction of variation in product characteristics and manufacturing process parameters
PED, PS, WS,
MFG., LC
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8.5.2 Corrective actionThe organisation shall take action to eliminate the cause of nonconformities in order to prevent recurrence.Corrective actions shall be appropriate to the effects of the nonconformities encountered.A documented procedure shall be established to define requirements for a) reviewing non-conformities (including customer
complaints) ,b) determining the causes of non-conformities,c) evaluating the need for action to ensure that non-
conformities do not recur,d) determining and implementing action needed,e) records of the results of action taken (see
4.2.4),andf) reviewing corrective action taken.
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Taking corrective actions including ALL
o reviewing non conformities o determining the cause of non
conformities (including customer complaints)
o evaluating the need for action to ensure that non conformities do not occur
o determining and implementing actions needed
o recording results of actions taken, and o reviewing corrective actions
Clause No 8.5.2
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8.5.2.1 Problem solving
The organisation shall have a defined process for problem solving leading to root cause identification and elimination.
If a customer-prescribed problem solving format exists, the organisation shall use the prescribed format.
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8.5.2.2 Error-proofing
The organisation shall use error-proofing methods in their corrective action process.
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Using error – proofing methods in the corrective action process.
ALL
Clause No 8.5.2.2
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8.5.2.3 Corrective action impact
The organisation shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.
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Applying corrective action and control implemented to other similar processes and products to eliminate the cause of non conformities.
ALL
Clause No 8.5.2.3
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8.5.2.4 Rejected product test / analysis
The organisation shall analyse parts rejected by the customer’s manufacturing plants, engineering facilities and dealerships. The organisation shall minimise the cycle time of this process. Records of these analysis shall be kept and made available upon request. The organisation shall perform analysis and initiate corrective action to prevent recurrence.
NOTE Cycle time related to rejected product analysis should be consistent with determination of root cause, corrective action and monitoring the effectiveness of implementation.
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Clause No 8.5.2.4 Analysing parts rejected (non-
conforming) at customer’s end. QA
Minimizing the cycle time for the analysis of rejected parts at customer end
QA
Records of customer end rejected parts analysis
QA
Performing analysis and initiating corrective action to prevent recurrence of rejection at customer end
QA
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8.5.3 Preventive action
The organisation shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
a) determining potential non-conformities and their causes,
b) evaluating the need for action to prevent occurrence of non-conformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing preventive action taken.
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Taking corrective actions including ALL
o determining potential non conformities and their causes
o evaluating the need for action to prevent occurrence of non conformities
o determining and implementing actions needed
o records of results of actions taken, and o reviewing preventive actions taken
Clause No 8.5.3
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THANK YOU