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  1. The PEAR Friday 2 November 2012

  2. The process approach • To understand PEARs you must first understand the process approach. • This approach isn’t new to QMS and has been around since ISO9001:2000, this has been further developed with the advent of ISO9001:2008 and AS9100 Rev C. • Also AS9101D has developed the process further using the Process Effectiveness Assessment Report – The PEAR

  3. Process Approach Model

  4. Process Performance • 0.2 Process approach (ISO9001:2008) • NOTE In addition, the methodology known as «Plan-Do-Check-Act» (PDCA) can be applied to all Processes. PDCA can be briefly described as follows. • Plan: establish the objectives and Processes necessary to deliver results in accordance with customer requirements and the organisation's policies. • Do: implement the Processes. • Check: monitor and measure Processes and Product against policies, objectives and requirements for the Product and report the results. • Act: take actions to continually improve Process performance.

  5. What does 9101D say about the PEAR? 3.7 Process Effectiveness Assessment Report (PEAR) • A document stating results and providing evidence of determination on the effectiveness of a process. • The PEAR is also discussed in clauses and

  6. What does 9101D say about the PEAR? • Process Management • The audit team should conduct quality management system audits using a method that focuses on process performance and effectiveness; this ensures that priority is given to the following: • reviewing the organization’s processes, their sequence and interactions, and performance against requirements and defined measures, with focus on processes that directly impact the customer; • reviewing the process based management techniques, including the examination of process controls (e.g., quality, takt time, cycle time, output effectiveness, control limits, process capability determination); • reviewing the process objectives/targets, with focus on areas where objectives/targets have not been achieved and on issues that have the greatest impact on the customer(s); • reviewing plans in place to ensure performance objectives/targets are met; • reviewing applicable corrective action plans in place where objectives/targets are not met; and • pursuing audit trails addressing customer concerns or requests for corrective actions, performance against objectives, and relevant process controls.

  7. What does 9101D say about the PEAR? • Process Management (Cont.) • The audit team should pursue process based audit trails by following actual products, customer orders, and related documents (e.g., customer contracts, drawings, shop orders, inspection records) through the organization’s product realization and associated processes; verifying the interfaces between processes and the linked documentation requirements (see 9100-series standards clause 4.2); resource management (see 9100-series standards clause 6); and measurement, analysis, and improvement (see 9100-series standards clause 8).

  8. What is a PEAR? Process Performance and Effectiveness • The audit team should audit processes to sufficient depth and detail to evaluate if the organization’s processes are capable of meeting planned results and performance levels, including applicable customer specific targets. • NOTE 1: Key Performance Indicators (KPIs) are often used to identify organizational emphasis areas and acceptable performance levels.

  9. What does 9101D say about the PEAR? Process Performance and Effectiveness • The audit team should evaluate, as appropriate, that processes: • are identified and appropriately defined; • are sequenced and interactions are defined (see 9100-series standards, clause 4.1.b); • NOTE 2: Often the output from one process directly forms the input to the next (see 9100-series standards, clause 0.2 Process Approach). • have responsibilities assigned and responsible functions identified; • have relevant process controls defined; • have the availability of resources and information required to operate and support associated activities, including appropriate training and competency of personnel; • are monitored, measured, and analyzed against planned results (determination of process effectiveness); • have actions implemented to achieve planned results and to promote continual improvement; and • are effective in achieving the desired results (e.g., verify performance information available - percentage of nonconforming parts/products, percentage OTD). • NOTE 3: Planned results can be related to process outputs or the associated activities.

  10. What is a PEAR • All third party auditors need to successfully complete the AATT Course which includes guidance on PEARs, there is also an IAQG online course covering PEARs and NCRs. • This will be included in the updated AATT course at the next revision which will coincide with the release of AS9101E

  11. Process Effectiveness Assessment Report (PEAR) • During your audit the level of effectiveness will be recorded on the PEAR for each of your audited product realization processes.  (Enquiries/Contract Review/NPI/Design/Purchasing/Manufacturing) • Non-conformances will be raised against clauses 4.1.c and f on process that are not effective or are not supported by actions with defined responsibilities and timescales.

  12. Process Performance • Therefore for a company to fully address AS9100 requirements: • All the Product Realisation processes and their interaction needs to be defined • Process performance indicators to measure process performance need to be defined • There must be a review process • If we take each of the above

  13. Process Performance • Product Realisation processes and their interaction:

  14. Defining and implementing your Process Performance KPI’s • A simple way to do this is with a KPI matrix, which can be used to identify the following: • Measurable • Frequency of measure • Owner (Department that owns the measure) • Responsible • Source of the data • Method of Calculation • Target • Type of Chart • Where reported

  15. Defining and implementing your KPI’s • We have developed the business plan objectives and completed the KPI Matrix identify the following: • Measurable • Frequency of measure • Owner (Department that owns the measure) • Responsible • Source of the data • Method of Calculation • Target • Type of Chart • Where reported

  16. KPI’s • KPI’s can be categorised as: • Customer Focus KPI’s, e.g. -To measure customer satisfaction • Operational KPI’s - To measure manufacturing performance and H&S • Supplier KPI’s - To measure supplier performance

  17. KPI’s

  18. KPI’s

  19. Defining and implementing your KPI’s • The next step is to Plan the calendar for the meetings, examples below: • Quarterly Directors Meeting • Monthly Management Meeting • Weekly Production Meeting • Monthly Safety Meeting and, the • Monthly Quality Meeting

  20. Typical Meeting Agenda

  21. Meeting Action Log

  22. Summary • For the KPI’s to be successfully implemented they must be: • Relevant to the business • Supported by senior management team • Have clear ownership • Realistic targets • Be reviewed on a Weekly, Monthly and Quarterly basis • When target is not being achieved the root cause identified and corrective actions implemented • When required, support is given to achieve the goals

  23. How to identify Performance Measure • From an audit perspective, it’s quite easy to identify the Performance Measure, note this should be done at Stage 1: • Is there a list of processes and their interaction • Is the process addressing product realisation • Is the process owner defined • Is there a target • Is there a review process

  24. Any Questions