Transcript ISO TS 16949 Tips and Traps.

QMS Tips and Traps
(ISO TS16949)
Presented by:
Bert Scali
Scali Consulting & Training
216-513-9147
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
QMS - General
Process names to match throughout the
organizations’ documentation (From the
organization’s 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… )
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 CSR’s…)
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 CSR’s (and sometimes for
documents – depending on customer
requirements)
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?)
Resources / Training and Competency
• Training looked at from company’s 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
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?
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…)
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?
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
• Don’t lose your PPAP records (scan for back
up) – “Active + 1 Year”
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 CSR’s
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
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?)
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
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.
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 CSR’s, Core tools, FAQ and
Sanctioned interpretations were part of the
internal auditing training / competency
Tips
• Get a written customer deviation if you only
want to do 30 piece capability studies
• Any issues with PPAP to OEM’s can easily
generate a Major NC during a 3rd party audit
• Rely on your internal audits to tell you the
system is working, don’t 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)