best quality policy to audit vendors

7/28/2019 Best Quality Policy to Audit Vendors

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Supplier Quality Management SystemAudit Checklist

(ISO 9000:2000, TS 16949:2002)

09/15/08 Rev. 1 John Farmer, Ph.D.

Supplier: _________________________________________________________________________________________________________________

Plant/Location: ________________________________________________ Date: _____________________________________

Audit Team: ___________________________________________

____________________________________________

____________________________________________

____________________________________________

Scope of Audit: ___________________________________________________________________________________________

Number of C.A.R. s: __________________________________________ Corrective Action Due: ___________________________________________

Potential suppliers may be requested to conduct a self-assessment of their quality system to determine eligibility. The Nova Sourcing Team shalldetermine eligibility after analysis of the self-assessment. Results of the Checklist shall be documented and communicated to the supplier by the NovaSourcing Team.

NOTE: Sections in red are questions relevant to TS 16949APPENDIX A


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8.2.2q5 The responsibilities and requirements forplanning and conducting audits and for

Can you show me your internal auditprocedure?


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10/15/08 Rev. 1 Page 35 of 45 John Farmer, Ph.D.

planning and conducting audits, and forreporting results and maintaining records(see 4.2.4) shall be defined in adocumented procedure.

procedure?

Can you show me the records ofinternal QMS audits?

8.2.2q6 The management responsible for the areabeing audited shall ensure that actions aretaken without undue delay to eliminatedetected nonconformities and their causes.

Who ensures that actions are taken toeliminate detected nonconformities andtheir causes?

Are they being taken care of in a timelymanner? (verify with records)

8.2.2q7 Follow-up activities shall include theverification of the actions taken and the

reporting of verification results (see 8.5.2).

What activities are done to verify theactions taken, and how are the

verification results reported?

NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.

8.2.2.1 Quality management system auditT8.2.2.1q1 The organization shall audit its quality

management system to verify compliancewith this Technical Specification and anyadditional quality management systemrequirements.

Do you have audit records showing thatthe entire QMS is being audited?

8.2.2.2 Manufacturing process auditT8.2.2.2q1 The organization shall audit eachmanufacturing process to determine itseffectiveness.

Do you have records showing that eachmanufacturing process is being auditedto determine its effectiveness?

8.2.2.3 Product auditT8.2.2.3q1 The organization shall audit products at

appropriate stages of production anddelivery to verify conformity to all specified

requirements, such as product dimensions,functionality, packaging and labelling, at adefined frequency.

Are there records showing that productsare being audited at appropriate stagesof production and delivery?

Do the audits verify conformity to allspecified requirements?

8.2.2.4 Internal audit plansT8.2.2.4q1 Internal audits shall cover all quality

management related processes, activitiesand shifts, and shall be scheduledaccording to an annual plan.

Can you show me an annual audit plan?

Does it show that audits cover all QMSprocesses, activities and shifts?


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8.5.2q4 e) records of the results of action taken(see 4.2.4)

Can you show me records of correctiveactions taken?


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8.5.2.1 Problem solvingT8.5.2.1q1 The organization shall have a defined

process for problem solving leading to root

cause identification and elimination.

Where is the process for problemsolving defined?

Does it lead to root cause identificationand elimination? (Review records)

T8.5.2.1q2 If a customer-prescribed problem-solvingformat exists, the organization shall use theprescribed format.

If one or more customer requires aspecific problem-solving format can youshow me records documented asrequired?

8.5.2.2 Error-proofingT8.5.2.2q1 The organization shall use error-proofing

methods in their corrective action process. Can you show that error-proofing

methods are used in the correctiveaction process?

8.5.2.3 Corrective action impactT8.5.2.3q1 The organization shall apply to other similar

processes and products the correctiveaction, and controls implemented, to

eliminate the cause of a nonconformity.

Can you show that corrective actions areapplied to other similar processes andproducts?

8.5.2.4 Rejected product test/analysisT8.5.2.4q1 The organization shall analyse parts

rejected by the customer's manufacturingplants, engineering facilities anddealerships. The organization shallminimize the cycle time of this process.Records of these analyses shall be keptand made available upon request. Theorganization shall perform analysis and

initiate corrective action to preventrecurrence.

Can you show me records of analysis ofparts rejected by customermanufacturing plants, engineeringfacilities and dealerships?

How long does the analysis take?

Are records made available (to

customers) upon request?

Is the time consistent with thedetermination of root cause, correctiveaction and monitoring the effectivenessof implementation?

NOTE Cycle time related to rejected product analysis should be consistent with the

determination of root cause, corrective action and monitoring the effectiveness ofimplementation.


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TAXA.1q3 Control plans are an output of the quality plan. Are control plans outputs of the quality plan?

A 2 Elements of the control plan


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A.2 Elements of the control planTAXA.1q1 The organization shall develop a control

plan that includes, as a minimum, thefollowing contents.a) General data

- control plan number,

- issue date, and revision date, if any,- customer information (see customer

requirements),- organization's name/site designation,- part number(s),- part name/description,- engineering change level,- phase covered (prototype, pre-launch,

production),- key contact,- part/process step number,- process name/operation description.

b) Product control- product-related special characteristics,- other characteristics for control

(number, product or process),- specification/tolerance.

c) Process control- process parameters,- process-related special

characteristics,- machines, jigs, fixtures, tools for

manufacturing.d) Methods

- evaluation measurement technique,- error-proofing,- sample size and frequency,- control method.

e) Reaction plan and corrective actions- reaction plan (include or reference),- corrective action.

Do the control plans include thefollowing minimum contents:

a) General data- control plan number,- issue date, and revision date, if any,- customer information (see customer

requirements),- Supplier's name/site designation,- part number(s),- part name/description,- engineering change level,- phase covered (prototype, pre-launch,

production),- key contact,- part/process step number,- process name/operation description.

b) Product control- product-related special characteristics,- other characteristics for control

(number, product or process),- specification/tolerance.

c) Process control- process parameters,- process-related special characteristics,- machines, jigs, fixtures, tools for

manufacturing.d) Methods

- evaluation measurement technique,

- error-proofing,- sample size and frequency,- control method.

e) Reaction plan and corrective actions- reaction plan (include or reference),- corrective action.

Additional audit checklist questionsQ# Requirement Text Audit Question Objective Evidence


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