AS9100C Internal Auditor part 3

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Conduct the Audit : Conduct the Audit 1 Copyright, Tom Scroggin 2012 Part 3 of 3

Configuration Audit (without design) : Configuration Audit (without design) Sample completed jobs. Verify the customer’s revision by checking the PO/contract. Check and verify that the proper revision was properly used. Check: Planning, drawings, FAI reports, supplier POs, final inspection reports, and all other related documentation. 2 Copyright, Tom Scroggin 2012

Configuration Audit (with design) : Configuration Audit (with design) Do everything on the prior slide and… Check your internal related and released documentation. This includes… BOM , drawings, work instructions, etc. 3 Copyright, Tom Scroggin 2012

Review Auditing Techniques : Review Auditing Techniques What is a good judge? 4 Copyright, Tom Scroggin 2012

Unbiased   Objective   Good listener   Independent   Professional : Unbiased Objective Good listener Independent Professional 5 Copyright, Tom Scroggin 2012

Clear   Concise   Open-ended   Professionally worded   Not personal --- The audit is about the process. : Clear Concise Open-ended Professionally worded Not personal --- The audit is about the process. 6 Copyright, Tom Scroggin 2012

Open Ended Questions : Open Ended Questions 7 Copyright, Tom Scroggin 2012

Which Questions are Open Ended : Which Questions are Open Ended What is your name? Have you been trained to do this function? Do you have the proper procedure available to you? Are these tools calibrated? Is the department meeting KPI targets? Do you have written criteria? 8 Copyright, Tom Scroggin 2012

None of those questions were open ended : None of those questions were open ended 9 Copyright, Tom Scroggin 2012

Open Ended Questions are not “YES” or “NO” : Open Ended Questions are not “YES” or “NO” You want the auditee to talk. Please describe this process. Please show me an example of … How do employees know if the tool to OK to use? What should be done if the unit fails? 10 Copyright, Tom Scroggin 2012

These questions are not about the person : These questions are not about the person Poor wording examples Please describe your process. Can you show me an example of what you’d do if … How do you know if the tool to OK to use? What should you do if the unit fails? Avoid the appearance of directing the audit at the auditee. 11 Copyright, Tom Scroggin 2012

Ask your Question : Ask your Question Then STOP talking. You must let the auditee answer the questions. A long pause is good – makes them talk! 12 Copyright, Tom Scroggin 2012

Control : Control Time is sort. Control your timing and keep the audit moving. Don’t allow the auditee to give you lengthy stories. Often the supervisor is present during the audit. Don’t let them answer questions directed to another person. If talking with a person who is operating a machine, ask them to stop. It may be unsafe to talk to them while they operate equipment. Control yourself – stay on task. Don’t touch things, you could damage something. When sampling records, you should select which to review, not the auditee. 13 Copyright, Tom Scroggin 2012

Some Basic Steps : Some Basic Steps Inform the area supervisor of audit date/time. Prepare for the audit, read the procedure that is applicable. Read the ISO paragraph(s) that are applicable. 14 Copyright, Tom Scroggin 2012

Audit Steps Continued : Audit Steps Continued Form any additional questions to those provided in the checklist. Check for any past audit findings and CARs . Introduce yourself and why you are there. Restate that this is a check of the process not the person. 15 Copyright, Tom Scroggin 2012

Audit Steps : Audit Steps Ask their name and keep it as part of the audit record. Ask your questions clearly. Restate their reply especially if there is a cause for concern. 16 Copyright, Tom Scroggin 2012

…and more steps : …and more steps If a problem is found, note it, get objective evidence, and inform the area supervisor. Always be nice. 17 Copyright, Tom Scroggin 2012

Close the Audit : Close the Audit Give feedback to the auditee on what you found good or bad. Keep complete notes including copies of evidence. Complete and sign the audit form. 18 Copyright, Tom Scroggin 2012

Write corrective action request if required.   : Write corrective action request if required. 19 Copyright, Tom Scroggin 2012

Audit Documentation : Audit Documentation 20 Copyright, Tom Scroggin 2012

Documentation : Documentation An internal program records: Audit plan/schedule (already covered) Audit and audit results (checklist) Corrective actions as appropriate 21 Copyright, Tom Scroggin 2012

AS9101 You do not have to use the forms in AS9101 for your internal audits; but you can. : AS9101 You do not have to use the forms in AS9101 for your internal audits; but you can. 22 Copyright, Tom Scroggin 2012

If you do wish to use AS9101 forms, you’ll need: : If you do wish to use AS9101 forms, you’ll need: Objective Evidence Record ( OER ) Process Effectiveness Assessment Report (PEAR) Quality Management System Matrix (QMS Matrix) 23 Copyright, Tom Scroggin 2012

Objective Evidence Record (OER) : Objective Evidence Record ( OER ) The OER is the “checklist.” On the OER records everything you have reviewed to assess the process. 24 Copyright, Tom Scroggin 2012

PowerPoint Presentation : Question Result Objective Evidence 25 Copyright, Tom Scroggin 2012

PEAR : PEAR The PEAR assesses effectiveness. Is the process performing as planned? Are actions taken when the process doesn’t meet objectives? 26 Copyright, Tom Scroggin 2012

PEAR Applicability : PEAR Applicability The PEAR applies to all processes you have identified that fall within section 7.1 – 7.5.5 of AS9100C . No need for a PEAR in the other sections (4.0, 5.0, 6.0 and 8.0). 27 Copyright, Tom Scroggin 2012

PowerPoint Presentation : 1 Auditing Company Name Process Effectiveness Assessment Report 2 Auditing Company Logo 3 Organization: Jim’s Machining 4 Site: Los Angeles 4 OIN: 12345 5 PEAR Number: 2 6 Audit Report Number: 100310 7 Issue Date: 10/29/10 8 Process Name: Project Management 9 Process details, including associated process interfaces: Inputs: Customer contract from Sales Dept. Outputs: product realization plans that include all requirements from Planning Dept. and programs for machining and quality plans. 10 Applicable 9100/9110/9120 clause(s): 5.4, 7.1, 7.2 11 Organization’s method for determining process effectiveness: Performance measures for quality and OTD 12 Auditor observations and comments supporting process effectiveness determination: Reviewed processes for contract review and planning. Verified objectives for quality and OTD . Targets are 99.5% quality, is 99.0%, 98.0% OTD , is 80.5%. No plans or CAR in place to correct/improve the OTD . 13 Statement of Effectiveness Level: The process is: 1. Not implemented; planned results are not achieved. 2 . Implemented; planned results are not achieved and appropriate actions not taken. 3. Implemented; planned results are not achieved, but appropriate actions being taken. 4. Implemented; planned results are achieved. 14 Auditor Name(s): Tom Scroggin 15 Auditee Representative Acknowledgement Name: Jim Davison 14 Signature(s): 15 Signature(s): 28 Copyright, Tom Scroggin 2012

NOTE 1: A major (ma) NCR shall be issued when the effectiveness level of the process is rated a "1". NOTE 2: A major (ma) or minor (mi) NCR shall be issued when the effectiveness level of the process is rated a "2". : NOTE 1: A major (ma) NCR shall be issued when the effectiveness level of the process is rated a "1". NOTE 2: A major (ma) or minor (mi) NCR shall be issued when the effectiveness level of the process is rated a "2". 29 Copyright, Tom Scroggin 2012

Practice : Practice 30 Copyright, Tom Scroggin 2012

   Audit of AS9100 rev C 8.3, Non-Conforming Product : Audit of AS9100 rev C 8.3, Non-Conforming Product NCP is not positively controlled until it is dispositioned scrap. The QA Manual defines responsibilities and authority. Rejections are very few <0.1% so there is no need for a special procedure. All dispositions are first approved by the customer. All rework is re-inspected. 31 Copyright, Tom Scroggin 2012

Audit of AS9100 rev C 8.3, Non-Conforming Product : Audit of AS9100 rev C 8.3, Non-Conforming Product You may have a few other questions first. If not positively controlled, then what controls are there? Confirm there is no procedure. Is the NCP tagged? Who is responsible? What happens to scrap? 32 Copyright, Tom Scroggin 2012

Any Findings? : Any Findings? 33 Copyright, Tom Scroggin 2012

Of Course : Of Course 34 Copyright, Tom Scroggin 2012

NCP is not positively controlled until it is dispositioned scrap. The QA Manual defines responsibilities and authority. Rejections are very few <0.1% so there is no need for a special procedure. All dispositions are first approved by the customer. All rework is re-inspected. : NCP is not positively controlled until it is dispositioned scrap. The QA Manual defines responsibilities and authority. Rejections are very few <0.1% so there is no need for a special procedure. All dispositions are first approved by the customer. All rework is re-inspected. 35 Copyright, Tom Scroggin 2012

Follow the Audit Trail : Follow the Audit Trail 36 Copyright, Tom Scroggin 2012

What Else Would You Look At? : What Else Would You Look At? 37 Copyright, Tom Scroggin 2012

How About These… : How About These… Verify each procedure requirement verses the procedure in place. Ask multiple people the same question. Ask about training. Ask about documentation. Can employees get to the procedures and forms? Who does what with the resulting records and data? How old is the NCP in the hold area? Too old? How are the storage conditions? 38 Copyright, Tom Scroggin 2012

Other Resources : Other Resources You will find additional training here at www.wizIQ.com AS9100C Requirements Training . ISO 9001:2008 Requirements AS9100 Revision C Management Overview. For software that manages all AS9100 records, see www.advancedquality.com or for a cloud-based solution, see www.advancedqualitylink.com Return to last slide viewed 39 Copyright, Tom Scroggin 2012

I hope this training has helped you to understand: 1) Auditing Basics 2) Auditing Requirements 3) Audit Preparation 4) Conducting the Audit 5) Audit Reporting 6) Follow Up : I hope this training has helped you to understand: 1) Auditing Basics 2) Auditing Requirements 3) Audit Preparation 4) Conducting the Audit 5) Audit Reporting 6) Follow Up 40 Copyright, Tom Scroggin 2012

Thank You for your time and best of luck auditing ISO 9001 and AS9100 : Thank You for your time and best of luck auditing ISO 9001 and AS9100 41 Copyright, Tom Scroggin 2012

Tom; a Short Bio : Tom; a Short Bio RAB certified Lead Auditor (AIEA # 03498) and certified Business Improvement Auditor. Small business owner of a job shop. Over 25 years in industry. Fifteen years of overseas business experience. Degrees in Business Organization, Quality, Metallurgy and International Trade. Several ASQ and ASNT certifications. Return to last slide viewed 42 Copyright, Tom Scroggin 2012

Tom Scroggin
ISO9001, AS9100 Quality Assurance Consulting
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