LAYERED AUDITSLAYERED AUDITS PURPOSE: To provide a system to: verify compliance to the documented process instill discipline improve communication improve overall quality Assembly Area Manufacturing Operations Shipping/Receiving Repair/Rework Area All Operations and other support functions RESPONSIBILITY: + Single Ownership - Plant Manager + Supported By - Quality Manager (0107282005. OSB WORKSHOP REV. 11 (02/1802) 2REQUIREMENT: Layered Audits shall be conducted for manufacturing and assembly of high risk items at a minimum of once per shift. Frequency of Layered Audits based on production volume or level of risk associated with process. Layered Audits supplement ongoing control plan and job instruction checks. A check list of high risk items to be verified during Layered Audits shall be established. Elements should be considered in developing the check list. (Example) 07012872005 OSB WORKSHOP REV. 11 (02/1802) 3(Example) Elements Utilization of manufacturing assists (as applicable) Gages functioning and calibration confirmation ‘Stacking / packing techniques Build / manufacturing techniques Visual aids presence and content Process parameter setting Job instructions Correct product identification Process steps adhered to Required inspections completed Torque monitoring (if applicable) Product dimensions or visual inspection Documentation / record completion Quality Gates (as applicable) Customer feedback (0107252008. OSB WORKSHOP REV. 11 (02/1803) 4 Sresenesneancaneses BaroneREQUIREMENTS (continued): + Layered Audits results shall be recorded. + Non-conformities shall be addressed immediately + Reaction plan(s) for non-conformities detected during Layered Audits shall be documented and available for use. + Corrective actions shall be documented. + Results shall be summarized and reviewed by the manufacturing site leadership. + Layered Audit documentation shall be compiled in the Lessons Learned (key strategy) database. (0107282005 O88 WORKSHOP REV. 11 (02/1803) 5REQUIREMENTS (continued): * Customer used features shall be identified, listed and checked in the manufacturing process with emphasis on: Supplier pass through features Mounting (holes, taps, etc.) Electrical connections/connectors Mounting surfaces Clearances Missing/wrong brackets Incorrect parts Others as identified by customer (0025/2005 OSB WORKSHOP REV. 11 (02/803) 6REQUIREMENTS (continued): + The following is an example of a Layered Audit with three levels of management involved in the process: - The manufacturing supervisor shall verify (daily) all quality documentation is completed by operators. - The manufacturing area manager shall verify (weekly) that supervisor verification is being completed. - Site leadership shall conduct layered audits at a frequency defined locally. (0107282008. OSB WORKSHOP REV. 11 (02/1809) 7 aRole NBS Rese a ani baie Example ered Rutan cS) GMPT model ‘CUSTOMER CONCERNS iseke pec riche External- PRR's, ete TEAMS Cross Functional Internal ‘Shainin AUDIT THE PROCESS 8 STEP Corrective Formal Line item document |, "Action CONTROL PLANS ~-Ttems Checked daily — Is the system working? “12:15pm, Report outs ‘What's critical to “Fast Response the process? |AUDIT % COMPLIANCE) JOB INSTRUCTIONS} ~Data Collection Participation -Standerdized Work Responsiveness “Integrity oy { RESULTS “Quality Improved -Quality Stabilized (0107252005 OSB WORKSHOP REV. 11 (02/7809) aLAYERED AUDIT MATRIX (Exampl (0102872005 QS@ WORKSHOP REV. 11 (02/180) °(Example) ane NAM: PRT NOME smurr: Clsrosne: DEPARTMENT werk ENDING: alellalele Plgye)ilali alflelé lila Ooi [ Ban i oi ar wit ance TGR) Has perpereviry boon goged 402-9507) Specs 20 ines Is there any broach tear? (Chock one part Fom each broach) op0 | Goksons 1s the 10 on size (Coline #2 & 377 isthe 1D run out win specications? sth 1D taper (etweon columns 2 & 3) within specication? ‘Op30_[ Hones asthe 1b Mleo been checked and the Mero Log completed? >| Entre Deparment ‘Are operators vericaion sheets completed daly by ahs? ‘Are ho tagging procedures beng flowed? ‘Are any Temporary Alert Notices posted thathave pied? 0028/2005 088 WORKSHOP REV. 11 (02/1803) 0(Example) PART NAME: PART NUMBEI ‘sur: WEEK ENDING: omb the bulla checking eiion & martina prs ouch point? Have the e-nole sprogs been nspeced for prosonce of holes and identified th orange marker? ‘Ae barcode labels ttced to shipping cvtaner in coreck locaten? hioing conainars checked or acual count? ‘Machining Operations Total Non-Conforming tems [_[—T [TT] Assembly Total Non-Conformina tems [TTT TT] LIST ANY QUALITY OR MANUFACTURING CONCERNS ON ALL OPERATIONS, (01072572005 SB WORKSHOP REV. +1 (02/1803) 1"(Example) DEPARTMENT LAYERED AUDIT RESULTS ITEMS NOT IN COMPLIANCE __ NUMBER OF OCCURANCES 070128/2005 OSB WORKSHOP REV. 11 (02/8103) 2(Example) LAYERED AUDITS RESULTS DEPT.., {FOF ITEMS ON ASSESSMENT: "FOF ASSESSMENTS] TOTAL WOF Meus ASSESSED. "FOF TENS IN COMPLIANCE} (01072812005 O88 WORKSHOP REV. 11 (02/1803) 8