ISO 9001-2015 Supplier Audit Checklist PDF

Preview

Summary

The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will pr...

Description

Supplier Audit Checklist System & Auditing

Process

Compliance

Insert your company’s name or logo.

ISO 9001:2015 Supplier Audit Checklist

System & Process Compliance Auditing

Guidance About this Checklist The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits: 

Ensures the audit is conducted systematically;



Promotes audit planning;



Ensures a consistent audit approach;



Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);



Provides a repository for notes collected during the audit;



Ensures uniformity in the performance of different auditors;



Provides reference to objective evidence.

This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a question. This audit checklist may be used for element compliance audits and for process audits. If you wish to create separate process audit checklists, select the clauses from the tables below that are relevant to the process and copy and paste the audit questions into a new audit checklist. We suggest that you retain this audit checklist as your ‘master copy’.

Document Ref:

Page 1 of 23

Insert your company’s name or logo.

ISO 9001:2015 Supplier Audit Checklist

System & Process Compliance Auditing

Audit Scoring Criteria A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The audit’s role is to provide assurance that key risks to your organization’s objectives are being well controlled. The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the audit, you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your audit report or management review documentation. This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely undertake. Finding

Definition/Impact

Action/Mitigation

COMPLIA NT

Compliant means adherence with the requirements of the standard and the QMS. The process is implemented and documented and records exist to verify this.

Continue to monitor trends/indicators.

OFI

A low risk issue that offers an opportunity to improve current practice. Processes may cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs may degrade over time to become non-compliant.

Review and implement actions to improve the process(s). Monitor trends/indicators to determine if improvement was achieved.

MINOR N/C

A medium risk, minor non-conformance resulting in deviation from process practice not likely to result in the failure of the management system or process that will not result in the delivery of non-conforming products nor reduce the effectiveness of the QMS.

Investigate root cause(s) and implement corrective action by next reporting period or next scheduled audit.

MAJOR N/C

A high risk, major non-conformance which directly impacts upon customer requirements, likely to result in the customer receiving non-conforming products or services, or which may reduce the effectiveness of the QMS.

Implement immediate containment action, investigate root cause(s) and apply corrective action. Re-audit in 4 weeks to verify correction.

Document Ref:

Page 2 of 23

Page 3 of 23

Document Ref:

INST racts , objectives, with Review othcustomer issues, problem areas. If they do not,sthe process. arerequirements always important were. not As you met.audit Is there the,evidence you will see thathow quality f the it connects process objectives being andand interacts audited. targetswith This affected info othermust by processes. this be process documented Audit are the being within relevant achiev thelink Q

PROCESS OUPUTS:

SS NAME/DESCRIPTION:

PROCESS INPUTS:

What is the product produced by this process? ps are involved in the process? at each step in the process? Are product measures in place to ensure that product meets ppens requirements? cuments and records are generated? How are processes measured? ocess implemented in accordance with procedures, instructions Are product and process measures achieved? ols applied as described? What feedback is received from customers?

What triggers the process? What inputs are required? Where do the inputs come from? Are they received in a timely manner? Are they fit for purpose?

NT & FACILITIES:

:

and resources areTraining required? Are andthere who is lists responsible? How are customer requirements defined? gh detail? What This specifications is often a finding, apply defined? where lists are generic ment with inadequate detail. is a key process of any system. Are the nt suitable and properly maintained? Is the work environment maintaine s apply process? dence of appropriate maintenance of all equipment used by this proces are there? What acceptance criteria exist?

Process Activity Map Insert your company’s name or logo.

System & Process Compliance Auditing

ISO 9001:2015 Supplier Audit Checklist

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Supplier Audit Questions Quality Management Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

1

Is the quality system documented, controlled and maintained to clearly describe current practice?

Quality manual and all procedures show revision control (sign-offs & dates), history of changes

2

Do quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis?

Product quality yield data, problems and corresponding improvement actions, status of preventive/ corrective/audit results

3

Are quality-performance targets clearly defined, included in the business plan and monitored for improvements?

Strategic and tactical objectives, goals, action plans, etc.

4

Does executive management participate in periodic quality system reviews that address quality related feedback from customers and internal quality metrics?

Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc.

Document Ref:

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Page 4 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Continuous Improvement Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

5

Are preventive actions taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs?

Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys

6

Is there a formal approach used to actively pursue cost containment and other continual improvement activities throughout the organization?

Employee involvement/recognition program, Lean, Six Sigma, kaizen, SPC, 5-S, cost reduction programme

7

Is a corrective action system in place that provides root cause analysis and takes timely and effective action to prevent recurrence?

Corrective actions, trend charts, meeting minutes, nonconformance frequency & cost analysis

8

Does the corrective action system cover customer, internal and supplier issues?

Management review meetings and corrective actions

Document Ref:

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Page 5 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Training & Awareness Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

9

Is the skill and education level required for each job documented and appropriate training provided?

Look for use of training aids and work instructions at work stations

10

Is employee qualification/certification maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill?

Qualification records, certification history

11

12

Are suitable methods used to verify training effectiveness?

Are suitable records of maintained?

Document Ref:

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Records of testing, production quality records, audit records, interview workers to validate training records Job descriptions, job skills assessment, training records, training manuals

Page 6 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Design & Development Support Audit Findings

13

14

15

16

17

Are customer needs and requirements incorporated into product designs and/or manufacturing processes? Are Critical-to-Quality (CTQ) characteristics are identified, understood and records retained? Are product specifications and drawings generated, controlled and maintained for new or changed product designs?

Is design validation is an integral part of the design process and occurs prior to production release?

Are human and technical resources are adequate to meet the requirements for design collaboration, tooling design and electronic drawing and data exchange?

Document Ref:

Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Market studies, customer/enduser surveys, technical design reviews Process capability studies, process plan, manufacturing verification tests Product characteristics, application requirements and other information for safe and proper use and disposal Design results, manufacturability, productivity and cost studies, confirmation that product fulfils its specified requirements or intended use or applications Qualification of technical staff. Equipment/software capabilities, CAD

Page 7 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Quality Planning Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

18

Are production samples inspected and provided to customers upon request?

Completed PPAP or similar forms, inspection reports, availability of qualified resources

19

Are customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis?

Procedures, design/process review, capacity plans, resource plans, product test, storage, packaging and shipment requirements

20

Are reliability test plans developed and routinely followed?

Provide suggestions for process improvement

Reliability test plans, test reports

21

Is testing is used to verify the design specifications, drive design improvements and provide an on-going check of materials and workmanship?

Improvement/corrective actions taken, design changes implemented

22

Is product reliability test data is available upon request and historical test performance data shows a highly stable process and product design?

Reliability test summary reports/charts

Document Ref:

Opportunities for Improvement (OFI)

Page 8 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Customer Documentation Audit Findings

23

Are new and revised customer specifications reviewed and implemented in a timely manner?

Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

Provide suggestions for process improvement

Technical review of methods to be used, capability studies on similar parts, documented review procedure

24

Are current process control documents in place and used for production start-up and continuing production?

Specifications, engineering drawings, change notices, work instructions and specifications as applicable

25

Does customer notification/approval occur for changes to control plans, manufacturing site, product transfers, raw material or product obsolescence?

Customer notification procedure on major changes

26

Is there a record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records?

Document control procedure

27

Are quality records maintained?

List of records to be kept with retention periods specified

Document Ref:

Opportunities for Improvement (OFI)

Page 9 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Procurement Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

28

Is there a formal process used for the selection, qualification and re-qualification of suppliers?

Supplier quality audits and corrective actions, engineering testing, approval records, production trials

29

Are purchases from unapproved suppliers prevented by a properly controlled and available approved supplier list?

Approved supplier list, procedures, production material receipt records

30

Are preventive actions taken to continuously improve performance of the supplier base?

31

Does the supplier assurance system ensure that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements?

Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance, component marking, labelling, etc.

32

Does a system exist for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost?

Procedures, segregation during storage, limited and controlled access to stored inventories

Document Ref:

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Supplier quality performance analysis, performance trends, supplier audit reports

Page 10 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Incoming Material Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

33

Is receiving inspection performed per documented procedures and detailed work instructions?

Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection

34

Is inspected material adequately identified as to acceptance or rejection and traceable to receiving inspection report?

Quality control label, marking or use of designated hold area as indicated in the procedure

35

Do supplier corrective action requests requiring root cause investigation show responses are analyzed?

Availability of written procedure, standardized corrective action form, analysis of corrective action cycle time and closure measurements

Document Ref:

Opportunities for Improvement (OFI) Provide suggestions for process improvement

Page 11 of 23

ISO 9001:2015 Supplier Audit Checklist

Insert your company’s name or logo.

System & Process Compliance Auditing

Manufacturing Quality Audit Findings Audit Evidence MAJOR N/C

MINOR N/C

Audit Question

OFI

Re f

COMPLIANT

(Score ‘1’ per box)

Provide reference to documented information to justify the finding

36

Is there is a formal method used to qualify new or rebuilt production equipment prior to production use?

Qualification plan that includes established goals for process yields. Records of process capability, review and approval

37

Are control plans used to plan and deploy inspection and test functions throughout the production process?

Process fow chart, statistical tools, key inspection points, inspection frequency, inspection/te...