1. HOW TO AUDIT AND TAKE AN AUDIT
Welcome to:
HOW TO AUDIT AND
TAKE AN AUDIT
Presented by:
Somashekar for Internal auditors
Modified from the original presentation of
JAN (“Yon”) ROOVERS
JAN ROOVERS ASSOCIATES, INC.
Charlotte, North Carolina

2. What is the purpose of an audit?: The purpose of an audit is to find
out how effective the Quality
Management System (QMS) and
its Processes are working.
The Auditors “Test the System.”
You are the process expert and
you can help the Auditors
understand how your process
works.

3. What do the Auditors verify?: Are the processes documented?
Are the processes implemented?
- Do you know and understand
the process?
Do you comply with process
requirements?
Are the processes effective?
Are the processes continually
improving?

4. What is expected of the Employees?: Know your process 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 process and
the product
Know and understand the
Quality Policy and Objectives
Ask, if you’re not sure……….

5. How do you prepare for an Audit?: Know and follow all your process
and product requirements
Be able to show the appropriate
documents that apply to your job
Check your process 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

6. Auditor questions……… When you start a new job, what do you do?
How do you check your work?
How often do you check your work?
Do you record the inspection results?
Where is this process written down?
Can you show me?
What do you do when you find something 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?
What happens if you find something wrong?
How do you know that your measuring tool is
calibrated?
What happens if you’re not here? (One person process)
Are you involved with correcting problems?
Are you involved with improving your process?
Etc…………

7. How to answer the Auditor’s 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!

8. Common Processes across
Control of documents
Control of records
Quality policy and objectives
Responsibility and Authority
Internal communication
Internal audits
Control of NC products
Data analysis and CAPA …

9. Ownership processes Infrastructure and work environment
Production and service provision
Customer related processes
Design and development
Purchasing
Customer property
Control of MMD
Monitoring and measurement of product

10. Look for the PDCA in audit
Every process area you audit must be working within the PDCA cycle.
PLAN
Look for the plan, This can be from an other process. Audit for how process interaction is effectively happening
Ex: Production schedule, Skill matrix, supplier selection, Competency and Training plan, Design plan, Out Sourced process determination…. etc

11. Look for the PDCA in auditDO
This is the activity of the area. Look for the responsibility, authority, communication, Records, outputs meeting inputs or the plan
Ex: Production records, PO generation, Records of training, Design i/p; o/p reviews, Outsourced process records,

12. Look for the PDCA in audit
CHECK
This is the activity of checking the DONE work. Look for responsibility, authority, How checking is done, evidences Etc.
Ex: Testing records, Training effectiveness, PO approval process, Design verification, Validation, Outsourced process effectiveness ..etc.

13. Look for the PDCA in audit
ACT
This is when changes are taken up with CHECKing data. Look for complaints handling, Improvements, Objectives improvement, Audit CA, Internal and supplier CAPA. Supplier re-evaluation, Training plans, Design changes control, New outsourcing controls .. Etc

14. Thank you for your attention
Are you ready
for the audit ?
Thank you for your attention
… any discussions ??