The PEAR Friday 2 November 2012

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

Process Approach Model

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.

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 4.1.2.4 and 4.1.2.5

What does 9101D say about the PEAR? 4.1.2.4 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.

What does 9101D say about the PEAR? 4.1.2.4 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).

What is a PEAR? 4.1.2.5 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.

What does 9101D say about the PEAR? 4.1.2.5 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.

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

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.

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

ADS UKLAI metrics/Clause 7 KPI’s ADS UKLAI metrics/Clause 7 Process No MEASURABLE FREQUENCY OWNER RESP SOURCE METHOD OF CALCULATION TARGET TYPE of CHART or REPORT WHERE REPORTED Customer KPI's P Manufacturing Delivery Schedule Achievement (Internal Measure) Monthly   (Total Number of Planned Deliveries Made - Total Number of Missed Deliveries) x 100 Total Number of Planned Deliveries Made 95% Graph & Summary Report Monthly/Weekly/6 Monthly Mgt Review Delivery Schedule Achievement (Customer Measure) Customer Delivery Performance Reports/Score Cards Customer Target Customer Satisfaction Review of Key data, I.e. Delivery, RFT, Corrective Action Reports/Project Status, and review of Customer Visits/Meetings Target Review of all customer related data RFT by Customer - External (Part shipped -Parts rejected) x 100 (Parts shipped) 99% NPI Project Status (New Customer) Project Status (Traffic Light System) Corrective actions on all Red/Yellow items. Green Status Report Nonconforming Corrective & Preventive Action Formal Customer Complaints Number of Corrective Action Reports raised (by customer) Formal Customer Complaints (Repeat Concerns) Number of Repeat Concerns Formal Customer Complaints (Response time) Total Days from Receipt of Complaint to Reply Supplier KPI's Purchasing Delivery Schedule Achievement (Supplier) Total Number of Deliveries made - Incorrect Deliveries x 100 Total Number of Deliveries Made RFT by Supplier (Part received -Parts rejected) x 100 (Parts received) Formal Supplier Concerns Number of Corrective Action Reports raised (by Supplier)

ADS UKLAI metrics/Clause 7 KPI’s ADS UKLAI metrics/Clause 7 Process No MEASURABLE FREQUENCY OWNER RESP SOURCE METHOD OF CALCULATION TARGET TYPE of CHART or REPORT WHERE REPORTED Internal KPI's P Sales/Enquiries Sales Turnover Per Month Monthly   Turnover £K Graph & Summary Report Monthly/Weekly/6 Monthly Mgt Review Finance Net Profit Turnover -(Fixed Costs + Marginal Costs) %age Wages Vs Turnover Wages Turnover -Purchases % Manufacturing Value Added Per Person Output Value - Input Value Number of Employees "" HR Employee Training & Development Total no of training & Development days per month Total no of Full Time Employees Purchasing Stock Turns Sales Turnover of Product Value of Raw Material + WIP + Finished Goods Floor Space Utilisation Sales Turnover of area Square metres of area OEE (Overall Equipment Effectiveness) Availability x Productivity x RFT Right First Time Index Parts rejected x 1,000,000 Parts Produced Direct Labour Cost Plan vs Actual Indirect Labour Cost Absence / Sickness Overtime Plan vs Actual (Hrs) TBD Training Executed to Plan Tooling Costs (£) Actual Cost v Budget Cost Preventive/Breakdown Maintenance Costs (£) Budget Monitoring Quality Scrap Non Quality (Cost of Quality) Cost of scrap + Cost of rework + Cost of Replacement Material Lost Time Accidents Total of lost time injuries (Hours) x 1,000,000 Actual Total Hours Worked in Financial Period Accidents, Near Misses Total number of near misses & description & action taken People Turnover - Permanent No of leavers x 100 Total People Sales by Industry Value of Sales by Industry Sector Sales by Business Unit Value of Sales by Business Unit Hit Rate No. Of Quotes Vs No. Of Won Orders Revenue Per Man Core Turnover*12 No. Of working weeks Efficency No. Of hours from direct staff Hours against jobs

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

Meeting Action Log

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

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

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