The audit frequency indicators will transfer to the other work sheets within this workbook for future reference during the next steps.

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Lydia Lloyd
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1 Introduction Process Assessment The process assessment is not a strict requirement in ISO 9:5 but it will help to substantiate your audit programme and to introduce risk based thinking into your audit process. Step Enter the process name(s) in cells 'B7' to 'B48'. Once you have entered the process name(s), they will copy through to the relevant sections of the remaining worksheets. Step Assess the criteria for ranking the status of processes. = Low All performance indicators, metrics, objectives, audit results, etc. show stability and consistently achieve targets; = Medium Minor problems exist, minor process or product changes planned; = High Poor performance/adverse trends, expected results not achieved; 4 = Critical Metrics are non-conforming. Any process with major audit finding in past months. Step Assess the criteria for ranking how well the process is performed. = Low Consistently applying documented practice, possible benchmark performer; = Medium Current practices conform but are not documented; = High Practices are applied inconsistently; 4 = Critical Practices are non-conforming. Step 4 Assess the criteria for ranking the importance of processes. = Low Little to no risk of adversely affecting customer satisfaction, product quality, delivery, or profitability; = Medium Adverse effect on customer satisfaction, product quality, delivery, or profitability; = High Likely have a significant adverse effect on customer satisfaction, product quality, delivery, or profitability; 4 = Critical Likely cause safety or regulatory compliance issues. Step 5 The audit frequency indicators will transfer to the other work sheets within this workbook for future reference during the next steps. An audit should be scheduled at least once per year unless otherwise justified; An audit should be scheduled within weeks and an additional audit within 6 months; An audit should be scheduled within 4 weeks with an additional audit after weeks and then reoccurring quarterly. Audit Programme Step 6 Enter the start and finish date for each planned, or additional audit, based on the frequency shown by the indicators. Please note that Columns A, B & C will automatically populate with information form the 'Process Assessment' worksheet. Only enter information in the grey coloured cells in Columns 'E', 'F', 'G' & 'H'. The formulas will then colour the relevant date/day cell(s) in the programme. Please note that all cells between 'I7' & 'I96' to 'ACA7' & 'ACA96' contain a hidden '' which is required for the 'date cell' shading formula - DO NOT DELETE! Begin auditing your system and processes, using the internal audit checklist. Audit Findings Tracker Step 7 From the 'Findings Summary' of the Audit Checklist, copy and paste the grey coloured cells into the corresponding cells in the tracker. Please note that Columns 'A', 'B' & 'C' will automatically populate with information from the 'Process Assessment' worksheet. Remember that when pasting data from the internal audit checklist into the tracker to select 'paste without formatting' from paste options menu. Audit Findings Charts Step 8 Copy and paste the charts into your internal audit reports or management review reports. Please note that the grey coloured columns will automatically populate with data from the 'Audit Findings Tracker' worksheet. Non-conformity & Corrective Action Tracker Step 9 Issue corrective actions to process owners. Monitor progress and verify close-out. Please note: the drop down box menu in Column 'B' is based on the processes that you entered in the 'Process Assessment' worksheet.

2 Process Assessment Step Enter the process name(s) in cells 'B7' to 'B48'. Once you have entered the process name(s), they will copy through to the relevant sections of the remaining worksheets. Step Step Step 4 Step 5 Assess the criteria for ranking the status of processes. Assess the criteria for ranking how well the process is performed. Assess the criteria for ranking the importance of processes. Audit frequency indicators will transfer to the 'Audit Programme' and the 'Audit Findings Tracker' for reference. = Low All performance indicators, metrics, objectives, audit results, etc. show stability and consistently achieve targets; = Medium Minor problems exist, minor process or product changes planned; = High Poor performance/adverse trends, expected results not achieved; 4 = Critical Metrics are non-conforming. Any process with major audit finding in past months. = Low Consistently applying documented practice, possible benchmark performer; = Medium Current practices conform but are not documented; = High Practices are applied inconsistently; 4 = Critical Practices are non-conforming. = Low Little to no risk of adversely affecting customer satisfaction, product quality, delivery, or profitability; = Medium Minor adverse effect on customer satisfaction, product quality, delivery, or profitability; = High Likely have a significant adverse effect on customer satisfaction, product quality, delivery, or profitability; 4 = Critical Likely cause safety or regulatory compliance issues. An audit should be scheduled at least once per year unless otherwise justified; An audit should be scheduled within weeks and an additional audit within 6 months; An audit should be scheduled within 4 weeks with an additional audit after weeks and then reoccurring quarterly. Perceived Process Ranking Perceived Effects on QEH&S Ranking Customer Complaints Any Known Corrective Actions Process Audit Ref. Process Name Critical 4, High, Medium, Low Critical 4, High, Medium, Low Actual No. of Complaints Internal CA (Audits/N/Cs) External CA (Audits/N/Cs) Status Status Practices Importance Quality Environment H&S Quantity Quantity Quantity Indicator IA Quality Management System IA Document Control IA Design & Development IA4 Manufacturing IA5 Customer Service IA6 IA7 IA8 IA9 IA IA IA IA IA4 IA5 IA6 IA7 IA8 IA9 IA IA IA

3 Audit Programme Step 6 Enter the start and finish date for each planned, or additional audit, based on the frequency shown by the indicators. An audit should be scheduled at least once per year unless otherwise justified; An audit should be scheduled within weeks and an additional audit within 6 months; An audit should be scheduled within 4 weeks with an additional audit after weeks and then reoccurring quarterly. Please note that Columns A, B & C will automatically populate with information form the 'Process Assessment' worksheet. Only enter information in the grey coloured cells in Columns 'E', 'F', 'G' & 'H'. The formulas will then colour the relevant date/day cell(s) in the programme. Please note that all cells between 'I7' & 'I96' to 'ACA7' & 'ACA96' contain a hidden '' which is part of the 'date box' shading formula - DO NOT DELETE! Begin auditing your system and processes using the internal audit checklist. Complete Audit Ref. Process Name Indicator Type Start Finish Duration (Yes/No) -Jan-6 8-Jan-6 5-Jan-6 -Feb-6 8-Feb-6 5-Feb-6 -Jan-6 -Jan-6 -Jan-6 4-Jan-6 5-Jan-6 6-Jan-6 7-Jan-6 8-Jan-6 9-Jan-6 -Jan-6 -Jan-6 -Jan-6 -Jan-6 4-Jan-6 5-Jan-6 6-Jan-6 7-Jan-6 8-Jan-6 9-Jan-6 -Jan-6 -Jan-6 -Feb-6 -Feb-6 -Feb-6 4-Feb-6 5-Feb-6 6-Feb-6 7-Feb-6 8-Feb-6 9-Feb-6 -Feb-6 -Feb-6 -Feb-6 -Feb-6 4-Feb-6 5-Feb-6 6-Feb-6 7-Feb-6 8-Feb-6 9-Feb-6 Planned 9-Jan-6 -Jan-6 day IA Quality Management System Additional -Feb-6 5-Feb-6 Day Additional 5-Feb-6 7-Feb-6 Day Additional Planned IA Document Control Additional Additional Additional Planned IA Design & Development Additional Additional Additional Planned IA4 Manufacturing Additional Additional Additional Planned IA5 Customer Service Additional Additional Additional Planned IA6 Additional Additional Additional Planned IA7 Additional Additional Additional Planned IA8 Additional Additional Additional

4 Audit Findings Tracker Step 7 Using the 'Findings Summary' section from the Internal Audit Checklist.docx, copy and paste grey the coloured cells into the corresponding cells below. Please note that Columns 'A', 'B' & 'C' will automatically populate with information from the 'Process Assessment' worksheet. Context of the Organization Leadership Audit Ref. Process Name Indicator Clause Question No. Criteria Section OFI IA Quality Management System OFI IA Document Control OFI IA Design & Development OFI IA4 Manufacturing OFI IA5 Customer Service OFI IA6 OFI IA7 OFI IA8 OFI IA9 OFI IA OFI IA OFI IA OFI IA

5 Audit Findings Charts Step 8 Copy and paste the charts into your internal audit report or management review report. Please note that the grey coloured columns will automatically populate with data from the 'Audit Findings Tracker' worksheet. Quality Management System Compliance Processes Compliance Clause OFI Quality Management System Compliance Charts Audit Ref. Process Name Total OFI Total Total Total Audit Findings Process Compliance Chart Context of the Organization 4. IA Quality Management System 46 Audit Findings per Process IA Document Control 5 7 Quality Management System IA Design & Development 4 6 Document Control 5 4. OFI IA4 Manufacturing 4 8 Design & Development IA5 Customer Service 5 Manufacturing IA6 Customer Service Leadership IA IA OFI IA IA IA Planning 6.. IA IA OFI IA IA IA6 Support 7.. IA IA IA IA IA IA Total OFI Total Total

6 Non-conformity & Corrective Action Tracker Step 9 Issue corrective action reports to process owners to initiate the close-out of any non-conformances. Monitor progress and verify close-out. Please note: the drop down box menu in Column 'B' is based on the processes that you entered in the 'Process Assessment' worksheet. CAR Ref. Process Name CAR Type How was it identified? Description of the CAR Non-conformance Report Ref. (If applicable) Root Cause Description of Corrective Action Date Assigned Assigned to Target Completion Closed-out (Yes/No) How was Close-out Verified? CAR Design & development Audit - Internal Design review minutes not authorized prior to release to client Not applicable Version control - using superseded template Department to ensure templates are updated -Jan-6 Jane Doe -Jan-6 Yes Visually confirmed that the correct template is available and is being used -Jan-6 CAR Manufacturing & warehousing Feedback - Customer Incorrectly shipped item NCR Item was mis-identified prior to storage Warehousing to investigate and correct labelling errors -Feb-6 John Doe 7-Mar-6 No CAR CAR4 CAR5 CAR6 CAR7 CAR8 CAR9 CAR CAR CAR CAR CAR4 CAR5 CAR6 CAR7 CAR8 CAR9 CAR CAR CAR CAR CAR4 CAR5 CAR6 CAR7 CAR8 CAR9 CAR CAR CAR CAR CAR4 CAR5 CAR6 CAR7 CAR8 CAR9 CAR4 CAR4 CAR4 CAR4 CAR44 CAR45 CAR46 CAR47 CAR48 CAR49 CAR5 CAR5 CAR5 CAR5 CAR54 CAR55 CAR56 CAR57 CAR58 CAR59 CAR6 CAR6 CAR6 CAR6 CAR64 CAR65 CAR66 CAR67 CAR68 CAR69 CAR7 CAR7 CAR7 CAR7 CAR74 CAR75 CAR76 CAR77 CAR78 CAR79 CAR8 Date Close-out Verified

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