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