qms a short way
TRANSCRIPT
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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)