Presentation on theme: "QMS Tips and Traps (ISO TS16949)"— Presentation transcript:
1 QMS Tips and Traps (ISO TS16949) Presented by: Bert Scali Scali Consulting & Training
2 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
3 QMS - GeneralProcess 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… )
4 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”( ) Risk Analysis ( compressed lead time, financial, investment, volume, new processes, new materials, new suppliers, new CSR’s…)
5 Document Control 188.8.131.52 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)
6 Purchasing 7.4 Which Vendors are being developed now? Vendor performance measurables called out in section 7.4 must be used as a minimum (Quality, Delivery, Customer disruptions, special status and premium freight)The organization shall promote supplier monitoring of the performance of their manufacturing processes (How are you doing that now?)
7 Resources / Training and Competency Training looked at from company’s eyes is different than auditorsCSR and their linked additional documents applicable to company are top priority, then TS, Design methods / Core tools, Job / work related skills, OTJEffectiveness of training and other actions determinedMotivation methods and measuring results of motivation in achieving objectives
8 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?
9 CALIBRATION / MSA7.6.2 Records of calibration… shall include… “revisions following engineering changes”Calibrate within the instruments measurement range7.6.1 MSA for ALL gages called out in Control PlanNDC : Should be 5 of higher7.6.2 Appropriate studies… (i.e. Bias, Linearity and Stability Studies)Internal lab scope (inspection, test or calibration…)
10 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 ScopeMaster samples identified with customer approval date?
11 PPAP/NC ProductOnly the customer can provide a waiver to ship product that is different than PPAP/ NC product different than print requirementsGet all customer waivers in writing and keep as quality recordsComplete PPAP – then submit the level the customer wantsDon’t lose your PPAP records (scan for back up) – “Active + 1 Year”
12 INTERNAL AUDITProcesses 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 organizationOnly 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
13 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?)
14 TipsCriteria should include Effectiveness and Efficiency of the processesOnly 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
15 TipsSeparate 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.
16 TipsIf Ford is a customer – the trainer of the internal auditors must meet additional requirements (Ford CSR # , and ).Evidence that CSR’s, Core tools, FAQ and Sanctioned interpretations were part of the internal auditing training / competency
17 TipsGet a written customer deviation if you only want to do 30 piece capability studiesAny issues with PPAP to OEM’s can easily generate a Major NC during a 3rd party auditRely 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)