ISO 9001 internal audit clause 4, 5, 6 and 8

Audit number(8) 2013.23

Audit date07.10.13

Completed byDale Town IRCA Lead Assessor ref R000378

Auditee name/sDave Turnbull

Internal audit scopes:

Clause 4, 5, 6 and 8 of ISO 9001:2008

PREVIOUS AUDIT CLOSURE ISSUES (ITEMS STILL REQUIRING EFFECTIVE CLOSURE) audit IDS 2, 3 and 4

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ISO 9001 internal audit clause 4, 5, 6 and 8ISO:9001: 2008 clause Number

QualityManualReference

Clause description Compliant

YES/NO

NCR Ref

4.1 QM 41 General requirements4.2 QM 42 Documentation requirements

4.2.2 QM 422 Quality manual Quality manual revised to ProActive format – document controlled via ProActive documents, extract page 1 2 and 3 evidenced below

Single word document manual containing all cross references to procedures and processes, issue status indicated on the manual as follows

Document Type: Systems ManualDocument Description: ISO 9001 Quality ManualDocument Number: QM1Issue level: 0001Issue date: 03/06/2013 13:53:01Approved By: Dave Turnbull (Management Rep), Philip Grindrod (Works Director)

Note minor index error corrected during audit quality manual now at issue level 0002

yes

4.2.34.2.4

QP01 Document and Records Control

Document Type: ISO 9001 ProcedureDocument Description: Document and Records Control

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8Document Number: QP01Issue level: 0001Issue date: 07/06/2013 11:22:35Approved By: Dave Turnbull (Management Rep)

Document control provided via ProActive, see list evidenced below (page 1 of 3 as sized below)

Document headers automatically created with applicable document control details example as illustrated above for QP01 and the quality manual.

Obsolete document control list evidenced above

4.2.3 QP01 Control of records (mandatory procedure)

Records control yes

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ISO 9001 internal audit clause 4, 5, 6 and 8The following records control list currently retained within ProActive

Page 1

Page 2

Note

Minor update to the list made during the audit referencing the quality manual as the record source for Management review records

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ISO 9001 internal audit clause 4, 5, 6 and 8

Quality record retention on ProActive – files illustrated above provide MR records between 23.11.10 and 23.04.13, Similar records retention for the ASL only on ProActive. Records retained outside ProActive as prescribed by the Records control list

5.0 QM 50 Management responsibility5.1 QM 51 Management commitment QM Policy statement as follows

The Alstons management team evidence their commitment to continual improvement of both business performance and the quality system by;

Continuously focusing the team on achieving customer requirements relating to statutory requirements and strategic business plans Alstons products comply with statutory requirements for fire and foam testing objective evidence for this provided by accompanying design process audit. Strategic business plans established by the senior team including the MD and fellow business Directors. Issues relating to the company’s QMS are channelled via periodic management reviews

Establishing, and reviewing the quality policy and associated business process performance. The quality policy is reviewed at periodic management reviews, see 5.6 below for objective evidence

Ensuring that strategic objectives are established implemented and measured see 5.4 below for objective evidence

Conducting management reviews – see QM 56 for objective evidence

yes

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ISO 9001 internal audit clause 4, 5, 6 and 85.2 QM 52 Customer focus Quality manual policy statement as follows

Customer focus is maintained by ensuring the following:

1. Client requirements and inputs are understood, defined and documented then converted into products and services through application of our key processes

The following key processes are in place and substantiate process customer focus

2. The measurement of Client feedback and satisfaction measurement (see QM821)

3.

yes

5.3 QM 53 Quality Policy Document Type: Policy StatementDocument Description: Quality PolicyDocument Number: QMP 01Issue level: 0001Issue date: 30/05/2013 18:58:58Approved By: Philip Grindrod (Works Director)

Policy statement complies with clause 5.3 of ISO 9001, see policy extract below

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8

5.4 QM 54 Planning5.4.1 QM 541 Quality objectives

.

Referenced in the quality manual in section QM541. Performance charts accessible via ProActive measurement and analysis, see image below copied objectives

Key Process Objective Measurement

P01Product Realisation

Achieve targeted levels of reduction for a four week rolling average measure for delayed suites. Main influencing factor known to be poor fabric lead time performance.

See ProActive measurement and analysis

P01 Achieve target levels of reduction for See ProActive measurement and

Yes

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ISO 9001 internal audit clause 4, 5, 6 and 8Product Realisation

fabric stock holding and reduce number of fabrics across all ranges.Main influencing factor is too many fabrics and too much stock of certain fabrics.

analysis

OBS Targeted levels of fabric stock exceeding agreed target levels, performance review recommended

OBS

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ISO 9001 internal audit clause 4, 5, 6 and 8

Delayed suites targeted performance being achieved

5.4.2 QM 542 Quality management system planning

Planning of the quality system is completed as a result of the following inputs:

Document reviews of key process and procedure contentObsolete documents list provides evidence see below

Management reviews – yes, see 5.6 Internal audit findings – yes, see 8.2.2

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8 Complaint corrective actions – NO Insufficient evidence within QMS to substantiate, see section 8 of

this audit report for further related commentary Preventive actions – as above Customer feedback and satisfaction measurement

5.5 QM 55 Responsibility, authority & communication

5.5.1 QM 551 Responsibility & authority The Managing DirectorThe Works DirectorThe Projects Engineer (Management Representative)

yes

5.5.2 QM 552 Management representative The Projects Engineer (Management Representative) yes

5.5.3 QM 553 Internal communication Alstons weekly brief Notice boards Management review Action log updates – see section 8 of this audit report for further related commentary Training sessions OFI Web based system option Internal audits

yes

5.6 QM 56 Management review5.6.25.6.3

QM 562 QM 563

Review input / Review output Last management review was held at Alstons 23.04.13, see extract of the MR record below for objective evidence

Example of inputs and outputs

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8

The following management review record files are held within ProActive

6.0 QM 6.0 Resource management6.2.2 QM 622 Competence, awareness &

trainingThe quality manual states e) Alstons Maintains appropriate records of education, training, skills and experience through application using ProActive , see training/competence

Training and competence records list provided by ProActive

Example training record directory extracted at random from the view folder function (Robert Sharpe)

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8

Additional training records for Robert Sharpe selected at random from sign off records

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ISO 9001 internal audit clause 4, 5, 6 and 86.3 QM 63 Infrastructure The following job sheets accepted as evidence of infrastructure maintenance

Maintenance job cards 1264,1270 and 1269

6.4 QM 64 Work environment No concerns – work environment observed in previous site internal audits is fully commensurate with the safe manufacture of quality upholstered furniture

yes

8.0 QM 8.0 Measurement, Analysis and Improvement

8.2 QM 82 Monitoring & measurement Policy statement provided in the current quality manual

Our organisation conducts measurement and analysis in order to

a) Demonstrate conformity and effectivenessb) Ensure conformity of the QMS to ISO 9001 and conformity of activities to the QMSc) Continually improve the effectiveness of the QMS.

yes

8.2.1 QM 821 Customer satisfaction Quality manual states

“Alstons Upholstery measures the level of customer satisfaction through the feedback reports from the sales team. Measurement includes remarks relating to models, reaction to new models, trends in each area, competitor performance and general remarks”

The following accepted as CSM objective evidence

Yes

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ISO 9001 internal audit clause 4, 5, 6 and 8

No CSM actions referenced in the action log CSM action code added to the action code list during this internal audit

Compliments letter re Richmond Sofa quality Feb 2013

8.2.2 QP03 Internal audits (mandatory procedure)

Document Type: ISO 9001 ProcedureDocument Description: Internal AuditsDocument Number: QP02Issue level: 0001Issue date: 07/06/2013 06:49:44

no

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ISO 9001 internal audit clause 4, 5, 6 and 8Approved By: Dave Turnbull (Management Rep)

Audit schedule in place at the time of the internal audit

OBS Internal audits 2, 3 and 4 require review and effective closure. Audit action log still at open status for referenced audits OBS

8.2.3 QM 823 Monitoring & measurement of process

The following

Process audits – see audit ProActive schedule abovePerformance measurements retained under ProActive Measurement & Analysis – see evidence presented in section QM541 of this report

yes

8.2.4 QM 824 Monitoring & measurement of product

See inspection and test requirements referenced under Key process PO1 and associated work instructions

Action log – periodic ‘Action category code’ reviews using ProActive reports

OBS No evidence product quality issues contained in the current action log

no

OBS

8.3 QP04 Control of nonconforming product (mandatory procedure required)

Document Type: ISO 9001 ProcedureDocument Description: Non Conformance, Corrective and Preventive ActionDocument Number: QP03Issue level: 0001Issue date: 07/06/2013 07:13:51Approved By: Dave Turnbull (Management Rep), Philip Grindrod (Works Director)

Procedure complies with clause 8.3 of ISO 9001:2008

Section 1.1 of the procedure

1.1 Non-conforming products shall be identified and segregated from conforming products through the following steps

yes

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ISO 9001 internal audit clause 4, 5, 6 and 8

Quantify and separate non-conforming from conforming products, identify non-conforming products through the following;IDENTIFY AND SEGREGATE NON CONFORMING IF REQUIRED TO PREVENT USING REJECT STICKERS

Update stock system if appropriate removing non-conforming products from visible good stock. Record non-conformity by entering the specific non conformity into the ProActive action log together

with the appropriate action code. If an action code is not available ProActive offers the facility to create a new action code.

Record traceability information, failure costs and any other information that may aid the investigation process in the ProActive action log.

See OBS in 8.2.4 relating to monitoring and measuring of the product

8.4 QM 84 Analysis of data See 5.4.1 and 8.5.2

8.5 QM 8.5 Improvement8.5.1 QM 851 Continual improvement Alstons Upholstery ensures continual improvement through effective application of the following:

It’s drive to achieve formal quality objectives. See 5.4.1

Corrective and preventive actions listed in the action and improvement log. See 8.5.2

The management review process, see 5.6 for evidence

yes

8.5.2 QP03 Corrective action (mandatory procedure)

Document Type: ISO 9001 ProcedureDocument Description: Non Conformance, Corrective and Preventive ActionDocument Number: QP03Issue level: 0001Issue date: 07/06/2013 07:13:51Approved By: Dave Turnbull (Management Rep), Philip Grindrod (Works Director)

The following corrective actions evidenced from the action log

NC issue – coded repairs AL00180008 03.06.13

Salcombe Chair which was returned for repair was repaired but was not loaded to be sent back to customer

Stated corrective action

If any item needs to be added to a shipment such as urgent, service issue, re-delivery or memo and is required for loading the same / next day then the Despatch Bay supervisor will be contacted by email and phone asking him to re-run the loaders report which will then pick up any new added items.

All action log entries – three in total between 22.11.12 and 01.06.13

no

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ISO 9001 internal audit clause 4, 5, 6 and 8

OBS The company does not appear to be taking full advantage of the action log through effective recording of product and process non conformities. This may be impacting on the on the effectiveness of the Alston quality management system

OBS

8.5.3 QP03 Preventative action (mandatory procedure)

Document Type: ISO 9001 ProcedureDocument Description: Non Conformance, Corrective and Preventive ActionDocument Number: QP03Issue level: 0001Issue date: 07/06/2013 07:13:51Approved By: Dave Turnbull (Management Rep), Philip Grindrod (Works Director)

No preventive actions documented in the current action log format

yes

INTERNAL AUDIT OBSERVATIONS

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ISO 9001 internal audit clause 4, 5, 6 and 8

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