qms A sHORT WAY

8/10/2019 qms A sHORT WAY

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QMS Tips and Traps

(ISO TS16949)

Presented by:

Bert Scali

Scali Consulting & Training

216-513-9147


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Customer Satisfaction

If the customers are not happy, the auditor is nothappy.

Score cards with unacceptable performance

generate NC (8.2.1) Poor customer satisfaction could be a symptom

of processes that are failing (What is it that couldhave failed and caused the

complaint/return/issue with the customer?)

Internal failures could be a leading indicator to letyou know that customer complaints are coming


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QMS - General

Process names to match throughout the

organizations documentation (From the

organizations Manual, process description and

the flow-down to other related docs the

organization may have, i.e. turtles, maps,

process flows, audit schedules, mgt. review )


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Sales

(7.2.1 d) any additional requirements

considered necessary by the organization.

Customer Specific Requirements/Supplier

Manualsconsidered at time of RFQ/Contract

to ensure ALL requirements can be met

(7.2.2.2) Risk Analysis ( compressed lead time,

financial, investment, volume, new processes,

new materials, new suppliers, new CSRs)


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Purchasing

7.4 Which Vendors are being developed now?

7.4.3.2 Vendor performance measurables called

out in section 7.4 must be used as a minimum

(Quality, Delivery, Customer disruptions, special

status and premium freight)

7.4.3.2 The organization shall promote supplier

monitoring of the performance of theirmanufacturing processes (How are you doing that

now?)


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Resources / Training and Competency

Training looked at from companys eyes isdifferent than auditors

CSR and their linked additional documents

applicable to company are top priority, then TS,Design methods / Core tools, Job / work relatedskills, OTJ

Effectiveness of training and other actions

determined Motivation methods and measuring results of

motivation in achieving objectives


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Resources / Training and Competency

Awareness of resources, especially withdownsizing/rightsizing is everything thatneeds to get done still getting done?

Are performance indicators suffering due toinadequate resources?

Are customer complaints increasing or are

these related to inadequate resources? Is the system being maintained while resource

adjustments are being made?


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CALIBRATION / MSA

7.6.2 Records of calibration shall includerevisions following engineering changes

Calibrate within the instruments measurementrange

7.6.1 MSA for ALL gages called out in Control Plan

NDC : Should be 5 of higher

7.6.2 Appropriate studies (i.e. Bias, Linearity

and Stability Studies) Internal lab scope (inspection, test or

calibration)


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APQP/PPAP

Inputs defined, documented and reviewed

Where are these documented?

What day where these reviewed and bywhom?

Where are the action items for Red/Yellows andwhat date do these need to be completed by?

PPAP package includes internal and external laboratory

Scope Master samples identified with customer approval

date?


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PPAP/NC Product

Only the customer can provide a waiver toship product that is different than PPAP/ NCproduct different than print requirements

Get all customer waivers in writing and keepas quality records

Complete PPAPthen submit the level the

customer wants Dont lose your PPAP records (scan for back

up) Active + 1 Year


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INTERNAL AUDIT

Processes defined by organization are theprocesses that are to be audited (same processnames from manual, to audit schedule, and toaudit records)

Evidence that internal auditors did audit the CSRsapplicable to the organization

Only internal audit results reported inManagement review (the standards states that

Audit results are the input, not just internalaudits, so external audit results need to beincluded


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Tips

Consider Active and Passive criteria for

process performance

Process descriptions not always clearly

defined, understood, known or explained to

the auditor. (Why are we still talking about

processes descriptions, years after the

standard/specification became effective?)


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Tips

Criteria should include Effectiveness and

Efficiency of the processes

Only the COPS have metrics?

Only Core Processes have metrics?

Only Manufacturing processes have metrics?

Should define measurables and pulse checksthat helps management make better decisions


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Tips

Separate Automotive vs. non-automotivemeasurables, such as customer score cards,customer performance (separate so you know

what your TS certified system is actually doing- remember that TS only covers automotiveproduction and service parts).

Link all cases of poor Customer scorecards/performance/complaints to a correctiveaction for analysis.


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Tips

If Ford is a customerthe trainer of the

internal auditors must meet additional

requirements (Ford CSR # 4.39.1, 4.39.2 and

4.39.3).

Evidence that CSRs, Core tools, FAQ and

Sanctioned interpretations were part of the

internal auditing training / competency


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Tips

Get a written customer deviation if you onlywant to do 30 piece capability studies

Any issues with PPAP to OEMs can easily

generate a Major NC during a 3rdparty audit Rely on your internal audits to tell you the

system is working, dont wait for the third

party auditor to break the news to you. Theseneed to be more detailed and depth than 3rdparty audits (Peel the onion)

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