Quality Management System awareness for all

QMS TrainingAn overview of the Quality

Management System

Prepared by:Anupam Ray

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Suitable for all kinds of interested audiences

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Facts about ISO 9001

1. ISO 9001 is being implemented in 175 countries around the world

2. Over 1.2 million certificates issued worldwide

3. ISO has 163 member countries


What is ISO 9001?

• It’s a quality management system that can be adopted by any kind of organization

• The system is focused towards the meeting of customer requirements and enhancing of customer satisfaction

Keywords: 1. Quality2. Management system3. Customer requirements4. Customer satisfaction

“Degree to which a set of inherent characteristics fulfils requirements”

(source – ISO 9001:2015)

What is quality….

Customers

provides

OrganizationProducts / services

requirements

supplies

Characteristics

How was it? Customer satisfaction survey

results

Satisfied? Not satisfied?

improve

1

2

3

4

5



“a system to direct and control an organization with respect to quality!!!”

(source – ISO 9001:2015)

What is Quality Management System….

Quality Management System

Processes

ObjectivesPolicies


“Quality Management System - Requirements”

ISO 9001:2015….

International Standard published by ISO

Prescribes set of requirements related to a quality management system

Conformity can be assessed internally as well as by external parties

World’s first certifiable QMS standard


QMS Model….

Results of the QMS

Quality Management System (4)

Organization and its context (4)

Customer requirements

Needs and expectations of relevant interested parties (4)

Customer satisfaction

Product and services

Leadership (5)

Improvement (10)

Support and Operation

(7,8)

Performance Evaluation (9)Planning (6)

PLAN DO

CHECKACT


Quality Policy….

Part of Quality Manual

Published on Intranet

Expresses Top Management’s commitment towards quality

All employees MUST understand and apply the quality policy


What is ISO 9001?

• This system has 5 components or elements and they are applied within your business management:a) Leadershipb) Planning c) Support and operationd) Performance evaluatione) Improvement

• Before we explore these elements, why is ISO 9001 necessary for our organization?


Why do we need ISO 9001?• To be effective in whatever we do, we need a system of

doing things to be consistent. Just like craftsmen, managers need a good management tool to get the job done.

• There are too many activities in any organization. Easy to lose track of things and focus. Easy to get distracted. Managers need a good system to keep things in order.

• Systemizing of activities is a natural phenomenon. We do it all the time – privately, publicly or commercially


Continue…..

• A business faces great risks – big investments, customer expectations, jobs, credibility, etc. The business owner must do all he can to ensure success, or he/she will fail.

• Every major economy in the world adopts it! Governments give recognition to it. Because it works.


Global Issuance of ISO 9001 Certificates

No of ISO 9001 certificates0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

2000200120022003200420052006200720082009


You already have a system of doing things too!

• But is it effective? If you keep doing what you always do, you will always get the same result.

• ISO 9001 is an option, a good one. It requires your organization to document your business processes (QMS), monitor, measure, analyze and improve it.

• Business owners and top management need to make a strategic decision on whether to implement the ISO 9001 QMS.


Biggest benefit• The ISO 9001:2015 Standard

provides managers with a tool that is designed to continually improve their business performance.

• ISO 9001 requires you to:– Plan what you want to do,– Follow that plan,– Monitor, measure and

analyze your execution of the plan, and

– Improve the plan.

Planning is the key

P D C A


• A well-designed and well-implemented quality management system can and should eliminate

• Ineffectiveness• Inefficiencies• Problems• Errors• Inconsistencies• Malicious practices• Uncertainties• Bad culture


What is ISO 9001?

• ISO - International Organization for Standardization

• isos - Greek - equal• 9001 - unique ID

number• 2015 = Year it was

published

Formation 23 February 1947 Type NGO Purpose Int’l standardization HQ Geneva Membership 63 countries Website www.iso.org No. of stds over 18,000

http://www.iso.org/


ISO 9000 Familya) ISO 9001:2015 Quality Management Systems –

Requirementsb) ISO 9000:2005 Fundamentals and vocabularyc) ISO 19011:2011 Guidelines for auditing management

systemsd) ISO 9004:2009 Managing for the sustained success of an

organization — A quality management approach

• The term “ISO 9000” is frequently used to refer to the ISO 9001 standard

• Only ISO 9001 is auditable. The rest serves as references only.


ISO 9001 History It all started when the US Military were getting sub-par products from their suppliers. Then it caught

on.

YEAR STANDARDS TITLE

1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS

1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS

1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE

1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING

1987 ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing

ISO 9002:1987 Model for quality assurance in production, installation, and servicing

ISO 9003:1987 Model for quality assurance in final inspection and test

1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE

2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS


What is ISO 9001:2015 Quality Management Systems - Requirements?

• Quality - degree to which customer requirements have been met

• Management - coordinated activities to direct and control an organization

• System - set of interrelated or interacting elements• Quality management system - a system to direct and

control an organization with regard to quality• Requirements - a set of management parameters for your

QMS


More about quality• How do you know requirements have been met?

– Review = confirm that requirements are accurate– Verify = measure accuracy of output against requirements– Validate = Get feedback from customer/end-user

• Nonconformance = failure to fulfill requirements• Nonconformance = error• All forms of nonconformance require corrections and

corrective action to prevent recurrences• Correction = Elimination of error• Corrective action = Elimination of the root causes of the

error (Ask WHY 5 times)


Root cause analysis

Root cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity

1. Why did the nonconformity occur?2. Why did the direct cause occur?3. Why did effect 3 occur?4. Why did effect 2 occur?5. Why did effect 1 occur?


8 Quality Management PrinciplesThe ISO 9001 Standard is based on these principles

1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to

management6. Continual improvement7. Factual approach to decision

making8. Mutually beneficial supplier

relationships


System approach

• Quality must be managed by a system to be effective• This system is done for you, as represented by the

ISO 9001:2015 standard• Recall: A system is a set of interrelated or interacting

elements• System approach is described in Clause 4.1• Combination of all Clause matches the PDCA

approach to process management - Plan, Do, Check, Act


System and process approach

• Quality must be managed by a system• The system must be managed using the

process approach because the system is made up of processes

• These processes are linked to each other• A process has inputs , resources, activities,

outputs and customers. Manage them all.


ISO Lingo

• Product = Any output- physical product or services• Output = Product/ Service• Product = result of a process• Process = a set of inter-relating activities focused

towards producing the output• Input = requirements

input process output


Process approach

input Your process output

Can be applied to any other process that you

manage

Or Service


Process approach• Every process require specific inputs, resources, activities,

outputs and customers• What you can do now is:

– Define and document the inputs– Define and document the kinds of resources that your process

use– Define and document the activities and their interactions– Define and document the responsibilities– Define and document the outputs

• You can name this document as Department Control Plan• Then execute this plan, and monitor, measure, analyze

and improve its performance (KPI)• Thus, Plan – Do - Check – Act (Edward Demmings)


Anatomy of a process

Process

Inputs

Activities

Outputs

Resources

Every process has an owner


Process management


Your QMS

Quality management

system

General requirements

Documentation requirementsLeadership

Support and operation

Performance evaluation

Improvement


Good records management

• Enables you toa) conduct business in an orderly, efficient and

accountable manner b) support and document decision making c) provide continuity in the event of a disaster d) meet legislative and regulatory requirements e) protect the interests of customers, employees

and stakeholders


Types of records/ documented Information to maintain

• Go through the ISO 9001 standard or your Quality Manual

• Identify the following phrases where they appear: “Documented Information …… shall be maintained”

• Most of the records requirements are readily available, such as product planning records, product design records, purchasing records, production records, monitoring records, analysis records, employee performance appraisal and training records, job descriptions, organization chart, infra maintenance records, contract/sales records, marketing records, customer complaints records, etc.

• Records pertaining to the mandatory SOP’s and quality objectives shall be created.

What to do• Read quality policy and quality manual• Establish a Quality Policy for your own Business.• Appoint a Management Representative• Establish a QMS Committee • Establish your Quality Manual• Establish the procedures Establish your Quality Plan• Establish your Department/Process Control Plans• Establish and document your quality objectives• Establish your KPI’s and start collecting data• Implement all the procedures


Key Performance Indicators• Ask this question when

determining KPI’s:• As the employee of this

organization, what data will instantly give me the ability to assess overall performance at any given point of time?

• Then list all them down and select your desired KPI’s.

Balanced scorecard

Financials

Processes

Customers

Human capital


• Can be used to benchmark performance based on input requirements (customer wants 100 units per month, so give them 100 units per month)

• Can be used to improve KPI performance levels – decision must be based on past performance data and existing capacity to be realistic

• You can use existing performance levels to establish your quality objectives

• Use quality objectives to improve on productivity levels, decrease errors, improve speed, reduce costs, reduce complaints, etc.

Quality objectives


Employee responsibility• Know the Quality Policy• Aware of the relevance and importance

of their activities and how they contribute to the achievement of the quality objectives

• Comply with the requirements of the QMS, as stated in the Quality Manual, procedures, Quality Plan, etc.

• Provide feedbacks or ideas about the QMS

• Report any nonconformities


Types of resources

• Determine , provide and manage the following:a) Competent human resources (competency

assessment, training needs analysis)b) Suitable and well-maintained infrastructures

(maintenance of buildings, hardware, software, transportation, utilities)

c) Suitable and well-maintained work environment (5S program)

d) Consider including financial management in your QMS to ensure product conformity


• Create a survey form which contains these columns: 1. Employee’s name2. Job position3. List of routine activities4. List of non-routine activities5. Key performance indicators6. Skills required7. Competency assessment per skill (use score ratings)8. Recommendation for training

• Employees fill in columns 1 to 4• Manager fills in columns 5 to 8• Benefits: Manager can identify work

redundancies, activity gaps, competency gaps, need for training and maybe the need to re-engineer the work processes

• Output: ?

Sometimes, work activities are not defined. So there’s a lot of confusion

Defining staff duties and responsibilities and analyzing training needs to ensure competence is essential


What’s a Plan?

PLAN

Duties and responsibilities

KPI & Quality

objectives

Flow of activities

Quality control

activities

Output description

Required physical

resources

Description of activities

SOP’s and records


Why monitor and measure?

• If you cannot measure it, you cannot improve it. Lord Kelvin

• Measurements provide you with a baseline to improve upon.


What do you measure?

1. Customer satisfaction (Survey, returns rate, complaints, lost business, etc)

2. Process conformance and effectiveness (internal audit)

3. Process performance (Key Performance Indicators and quality objectives)

4. Product characteristics (QC inspection before release to customer) where nonconforming products must be controlled


Internal audit process

• Purpose is to verify whether your QMS

a) Conforms to your Quality Plan,b) Conforms to ISO 9001 requirements,c) Conforms to your QMS requirements, andd) is effectively implemented and maintained.

Establish annual audit

schedule

Distribute Audit Plan

Perform audit

Report findings

Follow-up actions


Audit defined• Audit is a systematic and documented process for

gathering audit evidence and evaluating it against the audit criteria to determine whether it has been fulfilled

• Audit criteria is a set of policies, procedures or requirements

• Audit evidence is records, statements of fact or other information which are relevant to the audit criteria and verifiable

• Audit conclusion is the outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings


• What to ask?• What records to inspect?• What activities to observe?

1. Remember your purpose is to verify conformance and effectiveness against a specific requirement.

2. That requirement may come from the ISO 9001 Standard, your Quality Manual, SOP, etc.

3. So the answer depends on what audit criteria you want to verify

4. Remember, your job as an auditor is to look for the audit evidence, that’s all

5. So use the ISO 9001 Audit Checklist and start auditing.

Audit methodology

a) Interviewing the auditeeb) Inspection of documents

and records, etc.c) Observation of ongoing

activities


What do you analyze?

• Analyze what you measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC inspection resultsd) KPI resultse) Suppliers’ performance.


How do you analyze?• Line Chart/Trend Chart/Control Chart - used to detect trends and unusual

activities within the data set,• Pareto Chart Analysis - used to analyze the different components that make

up the data value in a descending order, complete with the cumulative percentage line superimposed on it,

• SWOT Analysis - used to analyze process strengths, weaknesses, opportunities and threats based on the characteristics of the data set - whether internal or external,

• Arithmetic average or mean - used to identify the average performance value of the process,

• Median - used to identify the actual middle value of the data set,• Mode - used to identify the most frequent value occurring within the data set,• Range - used to identify the difference between the lowest and highest values

,• Standard deviation – used to identify the SD from the mean• Cause and Effect Analysis - used to analyze the causes and effects of a given

data set, • Risk Analysis - used to identify potential risks given the data set


Pareto Principle20% of the causes contributes to 80% of the effects

• Identify and classify all problems

• Calculate cumulative occurrences up to 80%

• Focus on solving those problems

• Continually improve the management of those causes

• Analyze your sales figures and identify the contributors

• Focus your efforts on customers who contribute 80% of those sales

• Focus your efforts on the sales personnel who are managing those customers

Joseph M. Juran suggested the principle and named it after Italian economist Vilfredo Pareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of the population; he developed the principle by observing that 20% of the pea pods in his garden contained 80% of the peas.


What to improve?

• The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

• All nonconformities require corrective actions• All potential nonconformities require preventive

actions.


Corrective action process

Detect nonconformity

Report nonconformity

Review nonconformity against criteria

Issue CARPerform root cause analysis

Evaluate need for corrective

action

Implement corrective

action

Record the results of

actions taken

Verify effectiveness

of actions taken


Preventive action processDetect

potential nonconformity

Report potential

nonconformity

Review against criteria

Issue PARPerform root cause analysis

Evaluate need for preventive

action

Implement preventive

action

Record the results of

actions taken

Verify effectiveness

of actions taken


Risk analysisPerforming a risk analysis on your business processes can help you detect potential nonconformities

• Describe the risk• Describe the potential effects• Quantify likelihood of occurrence

(consider frequency)• Quantify severity of consequence

(consider harm or damage)• Assign risk rating (likelihood x

severity)• Risk rating > 4 shall be controlled

(ALARP = as low as reasonably practicable)

Score ratings1 = very low2 = low3 – moderate4 = high5 = very high


Root cause analysis

Root cause Effect Effect Direct cause Nonconformity

causes effect

Sources of direct causes:1. Human error,2. Material defect,3. Equipment malfunction,4. Ineffective methods of operation or control, or5. Flawed management policies.


Nonconformities

• Don’t fear them because

–We detect and report them because we don’t want them to recur–We report and record them because we

want to document the improvements made to the QMS


Hope you benefited from that presentation

Quality Management System awareness for all

Education

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