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Preparation for Third Party Audit

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Presentation on theme: "Preparation for Third Party Audit"— Presentation transcript:

1 Preparation for Third Party Audit
11/08/02 Understanding Our ISO-9000 QUALITY MANAGEMENT SYSTEM In Preparation for Third-Party Audits DEP

2 Preparation for Registration Audit
Preparation for Third Party Audit 11/08/02 Preparation for Registration Audit Purpose for the Audit How the Audit involves you General Understanding of the Quality System Find where you are positioned in the Extended Organization Chart Find what SOPs may direct your activities and/or define your responsibilities Answering Auditor Questions Practical Preparation for the Audit 11/08/02 DEP DEP

3 Primary Reasons For Quality System Audits
Preparation for Third Party Audit Primary Reasons For Quality System Audits 11/08/02 Assure Customers that our Quality System Complies with the ISO Quality Standard Assure Management of Compliance Identify Opportunities for Correcting and Improving the Quality System 11/08/02 DEP DEP

4 Preparation for Third Party Audit
11/08/02 Elements of the Audit 11/08/02 DEP DEP

5 Preparation for Third Party Audit
11/08/02 A Quality Audit is NOT An Interrogation An Inspection A Policing Activity 11/08/02 DEP DEP

6 Preparation for Third Party Audit
11/08/02 What Hat are You to Wear? Auditor - Person performing the Audit Client - Person or Organization requesting the Audit Auditee - Organization, Facility, or Person being Audited 11/08/02 DEP DEP

7 What will the Auditors Do?
Preparation for Third Party Audit 11/08/02 What will the Auditors Do? Look at System Documentation to Verify Existence Observe How Personnel perform their responsibilities to Validate Current Implementation Look at Quality Records to Validate Past Implementation Review Qualifications & Training to Validate Proper Implementation 11/08/02 DEP DEP

8 Preparation for Third Party Audit
11/08/02 What You Are NOT To Do! REACT Antagonistic Challenging Divisive 11/08/02 DEP DEP

9 Preparation for Third Party Audit
11/08/02 ISO 9000 REQUIREMENTS MANAGEMENT RESPONSIBILILTY RESOURCE MANAGEMENT PROCESS MANAGEMENT MEASUREMENT, ANALYSIS & IMPROVEMENT INPUT PROCESS OUTPUT QUALITY SYSTEM BINDER SYSTEM PROCEDURES QUALITY MANUAL DEPARTMENTAL INSTRUCTIONS CALIBRATION INSTRUCTIONS A QUALITY MANAGEMENT SYSTEM ? 11/08/02 DEP DEP

10 Preparation for Third Party Audit
11/08/02 International Quality Standard ISO 9000 OUR Quality System Defines Policy Roles & Responsibilities System Manual Inter - Departmental (Who, What, & When) Procedures Intra-Departmental (How) Instructions DOCUMENTATION PYRAMID 11/08/02 DEP DEP

11 Control of System Procedures
Preparation for Third Party Audit 11/08/02 Control of System Procedures System Controller is Controlled on LAN System by Controlled Hard Copies in ISO Binders 11/08/02 DEP DEP

12 Preparation for Third Party Audit
11/08/02 SOP Functional Responsibility & Authority Matrix Functional Organizations PROCEDURE TITLE SOP NO. A101 Control of System Documentation & Data A102 Training & Qualification A103 Issuance of Purchase Orders A104 Vendor Qualification A105 Management of Our Quality System E101 Control of Numerical Control Programs President Office, Accounting, & MIS Support Administration Customer Service Project Management Buyer / Expediter Quality Assurance Technicians Receiving & Shipping and Maintenance Quality Assurance Manager Equipment, Facility, & Maintenance Manager V.P. Manufacturing Manufacturing Department Managers Operators & Technicians V.P. Sales & Marketing Management Tool Identifying Procedural Participation By Department / Function Associated with SOP A105 11/08/02 DEP DEP

13 Examples of Auditor Questions
Preparation for Third Party Audit Examples of Auditor Questions 11/08/02 What are your job responsibilities? Are they defined anywhere? How were you trained and/or qualified to perform your job? Are there records that give evidence to this? Where are they located? Are there procedures that tell WHEN you are to perform your responsibilities? If so, where are they located? Are there procedures that tell HOW you are to perform your responsibilities? If not, why? If so, where are they located? How or who controls these procedures? How do you know they are the current version? 11/08/02 DEP DEP

14 Examples of Auditor Questions
Preparation for Third Party Audit 11/08/02 Examples of Auditor Questions Are you responsible for performing Inspection and Testing of the product? If so, how do you record your results? If not, are you responsible for handling, storing, and/or packing the product? What are you to do when you suspect that the product does not conform to established requirements? How do you know if the gages you use during the Inspection and Testing are properly calibrated? How is product identified as it enters your work cell or station? How is it identified when it exits? How do you know if product has passed the required Inspection and Testing? 11/08/02 DEP DEP

15 Examples of Auditor Questions
Preparation for Third Party Audit 11/08/02 Examples of Auditor Questions If you can, tell me how the company is better off today with ISO-9001 as a standard … versus a year ago? What is the Company Quality Policy? How does it relate to your job responsibilities? Does your job require you to use statistical methods? If so, what methods and how are they used (control and/or verify what?)? What forms and/or records do you use while performing your job? Are you responsible for retaining any of these records? If so, how are they stored, how long are they to be kept, and who has access? 11/08/02 DEP DEP

16 Guidelines on Dealing with Auditors
Preparation for Third Party Audit 11/08/02 Present a polite and professional attitude Listen carefully to the auditors Answer their questions accurately (No Wild Guesses), factually (No Personal Opinions), and to the best of your knowledge Avoid volunteering information Do not try second guessing what the auditor is trying to ask Admit when you do not understand the question Be honest if you do not know the answer to a question (You may volunteer to research the question and get back with an answer by a designated time) Stay calm and always be cooperative DEP

17 Preparing Your Work Area for Audits
Preparation for Third Party Audit 11/08/02 Preparing Your Work Area for Audits All files and documents should be neatly organized. All hand written “cheat sheet, crib notes,” and/or uncontrolled instructions should be removed from the area or equipment. If they are important and without them quality may be adversely affected, they should be formally incorporated into the applicable documentation system. All proprietary and confidential information should be filed away and not left in the open. All media (Diskettes and CDs) should be in jackets labeled and stored appropriately. DEP

18 Preparing Your Work Area for Audits
Preparation for Third Party Audit 11/08/02 Preparing Your Work Area for Audits All active records and documents should be organized so they are easily retrievable. All obsolete documentation and data should be destroyed or identified as “Obsolete” and removed from the active documentation and data. Areas should be free from debris and litter. DEP


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