QMS Tips and Traps (ISO TS16949)

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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
  not happy.
• 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
  could have failed and caused the
  complaint/return/issue with the customer?)
• Internal failures could be a leading indicator to
  let you 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 Manuals
  considered 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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Document Control

• 4.2.3.1 Engineering specs and standards
• External documents controlled, available, known
  and implemented within the processes where these
  apply (i.e. CSR/supplier manuals)
• 4.2.4 Retention timing of records to be
  consistent with CSRs (and sometimes for
  documents depending on customer requirements)

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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 their
  manufacturing processes (How are you doing that
  now?)

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Resources / Training and Competency

• Training looked at from companys eyes is
  different than auditors
• CSR and their linked additional documents
  applicable to company are top priority, then TS,
  Design methods / Core tools, Job / work related
  skills, 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 with
  downsizing/rightsizing is everything that needs
  to get done still getting done?
• Are performance indicators suffering due to
  inadequate 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 include
  revisions following engineering changes
• Calibrate within the instruments measurement
  range
• 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 by
  whom?
• Where are the action items for Red/Yellows and
  what 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 to ship
  product that is different than PPAP/ NC product
  different than print requirements
• Get all customer waivers in writing and keep as
  quality records
• Complete PPAP then 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 the
  processes that are to be audited (same process
  names from manual, to audit schedule, and to
  audit records)
• Evidence that internal auditors did audit the
  CSRs applicable to the organization
• Only internal audit results reported in
  Management review (the standards states that
  Audit results are the input, not just internal
  audits, so external audit results need to be
  included

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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/specificati
  on 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 checks that
  helps management make better decisions

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Tips

• Separate Automotive vs. non-automotive
  measurables, such as customer score cards,
  customer performance (separate so you know what
  your TS certified system is actually doing -
  remember that TS only covers automotive
  production and service parts).
• Link all cases of poor Customer score
  cards/performance/complaints to a corrective
  action for analysis.

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Tips

• If Ford is a customer the 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 only want
  to do 30 piece capability studies
• Any issues with PPAP to OEMs can easily generate
  a Major NC during a 3rd party 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. These need to
  be more detailed and depth than 3rd party audits
  (Peel the onion)