1. Quality Audits, and How to Survive them

2. Types of Audits First Party
Internal audits of the Quality Management System and Processes, performed by trained Internal Auditors
Second Party
External or Extrinsic Audits performed between Customers and Suppliers. Usually performed by trained Auditors from the Organisation
Third Party
Extrinsic Audits performed on the Company’s
Quality System and Processes by
independent bodies, eg. Notified Body Audits
for ISO 13485, performed by Independent
Auditors

3. First Party Audits
Purpose
Investigate the effectiveness of the Company’s Quality Management System and it’s processes
Identify opportunities for improvement
Evaluate training needs
Ensure compliance with standards and regulations
Auditor?
Trained Internal Auditor, independent of
process being audited

4. First Party Audits What will be audited?
Procedures and activities related to the process being audited eg. purchasing, Goods-In Inspection.
Audit Report / Outcome
A written report detailing positive findings, non-conformances, observations and the audit score, together with an Action Plan.
- Non-conformances are issues that breach the associated standard, and are split into major and minor.
- Observations are issues that could lead to a non-conformance, or serve as recommendations for improvement

5. Second Party Audits
Purpose
Investigate the effectiveness of Supplier’s Quality Management Systems to establish suitability for supply of components or services, and ensure ongoing assessment of existing Suppliers
Auditor?
Usually a Trained Internal Auditor

6. Second Party Audits What will be audited?
The Organisations Quality Management System for compliance with specified standards and regulations, or specific areas of interest.
Audit Report / Outcome
A written report detailing positive findings, non-conformances, observations and the audit score.

7. Third Party Audits
Purpose
Internal audit of the Quality Management System and all associated processes to ensure ongoing effectiveness and compliance with specified standards.
Auditor?
An independent Trained Auditor

8. Third Party Audits What will be audited?
The Organisations Quality Management System
for compliance with specified standards and
regulations.
Audit Report / Outcome
A written report detailing positive findings, non-conformances and observations.
Recommendation for certification to selected quality standard (hopefully!)
Continued certification to specified quality standard/s and regulations (double hopefully!)

9. How are Audits arranged and performed?
Audits are performed to an audit schedule: First Party Audits – Every process to be audited within a 12 month period Second Party Audits – To be performed on all critical component Suppliers Third Party Audits – Once certified, surveillance audits every 6 months

10. What do the Auditors look for?
Are processes documented?
Are processes implemented?
- Do relevant persons know and understand their process?
Do you comply with process requirements?
Are the processes effective?
Are the processes continually improving?

11. What is expected of the Employees?
Know you processes and product requirements
Know exactly what to do and how
Understand your role in the QMS
Help correct process and product problems?
Help improve the processes and the QMS
Know and understand the Quality Policy
and Objectives
Ask, if you’re not sure……….

12. Auditor Requirements Ethical Professional Fair and patient
Assertive but not aggressive
Enquiring but not gullible
Co-operative but not compromising
Persuasive, not abrasive
Thick skinned and resilient

13. Auditee Requirements Guidance for Auditees When being audited: -
Be honest, open and cooperative
Ask the auditor to explain if you’re not sure what they require.
Only answer the questions being asked - name, rank and number!
Don’t draw attention to problems - but don’t try to hide them
Don’t blame others
Be truthful - once credibility is in doubt . . .
Prepare in advance - check your documentation, etc.
If you don’t know, say so - but add that you will find out
If you disagree with the Auditors findings, ask for clarification

14. Auditor Questions What do you do when you start a new job?
How do you check your work, and how often?
Do you record the inspection results?
Where is this process written down and Can you show me?
What do you do when you find something is wrong?
Can you explain your company’s quality policy?
Do you know the objectives for your process?
Are these objectives measured? Can you show me?
How do you know that your measuring tool is calibrated?
What happens if you’re not here, who is your deputy?
Are you involved with correcting
problems?
etc…..

15. How to answer the Auditors Questions
Be polite and honest.
Answer only the questions that are asked.
Do not volunteer information.
Never lie!!
Answer directly and with confidence.
It’s OK to ask for clarification.
It’s OK to say: “I don’t know.”
It’s OK to say: “That’s not my responsibility” but be prepared to say who is.
Remember, the Auditors are not out “to get you.”
They are only TESTING the quality system and its processes. You help
the Auditor understand how your process works. That’s all!

16. How not to answer the Auditors Questions
DO NOT!
Bluff your way out of trouble
Lie, you are allowed to not know the answer
Waffle, answer only the question asked
Argue with the Auditor
Provoke the Auditor
Bribe the Auditor
Sidetrack the Auditor, they almost
always remember to go back to
things missed and stay on track.

17. How do you prepare for the audit?
Know and follow all your process and product requirements
Be able to show the appropriate documents that apply to your job
Check your processes and work area
- Clean, well-organized, all product identified,
calibrations up-to-date, all checks/inspections
completed, all “paperwork” correctly filled-out
Anything you don’t know? ASK!!!!
Be prepared to answer the Auditor’s questions

18. Audit Process FOUR PHASES an opening meeting / discussion
the audit itself
completion of an audit report/audit documentation
a closing meeting.

19. Audit Report
Details what was seen, and includes reference to documents reviewed.
Highlights Non-conformances and Observations, together with proposed actions
Should include positive comments relating to the Processes audited.
For third party audits will be presented at
the Closing Meeting
For first and second party audits, will be
presented within a fortnight of completion.

20. Audit Follow-up
The reports become the property of the Quality Manager and will be held in the Open Audit file until all
actions have been addressed.
When all actions have been addressed, the Lead Auditor will verify them, and if acceptable close the audit and place it into the Closed Audit file.
If verification shows that the actions have not been effective, new actions will be proposed.
Any queries should be directed to the lead auditor.

21. Are you ready
for Quality Audits?