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)