Transcript Points.

Question 1.

What’s the missing word? “If it hasn’t been recorded,
it hasn’t been ****.”
Answer.

DONE
Points.

1 point.
Question 2.

In a sentence, what makes a company a ‘quality’ company?
Answer.

It provides both supplier and customer with good/quality
service and/or goods
Points.

1 point for each of:
- supplier,
- customer/client,
- good/quality/to standard/on time
- product/goods/service.
(5 points if all 4)
Question 3.

What are the two most important resources of a quality
company?
(both beginning with a P)
Answer.

Its PRODUCT and its PERSONNEL
Points.

1 point for each
Question 4.

What is the main reason for quality certification?
Answer.

To satisfy our customers and (occasionally) suppliers.
(And they are getting more demanding.)
Points.

1 point.
Question 5.
•
When you have completed a business record or
document, where should you store it?
Answer.

In its defined corporate storage area (as per Document
Management Procedure).
Points.

1 point.
Question 6.

Give the 2 main reasons why.
Answer.

So that it can be accessed by those who need to know.

So that it is secured by the company.
Points.

1 point for each.
Question 7.

Where can you find the quality rules for doing
work at [insert your organisation name here]?
Answer.

In the Quality Management System, under Quality
Procedures.
Points.

1 point for Quality Management System: another
Quality Procedures or QP.
Question 8.

Where can WE find what YOUR job is?
Answer.

[Define answer according to your organisation.]
Points.

1 point.
Question 9.

Is it up-to-date?
Answer.

Yes, no or don’t know.
Points.

Yes is worth 1 point. Anything else scores zero
unless you have actively begun to update it.
Question 10.

If you are fed up, what two things should you do about it?
Answer.

Work out why

Talk to your Line Manager about it.
Points.

1 point for each. Score -2 for ‘Look for another job’.
Question 11.

What does ISO 9001 suggest we always need to have
before attempting to do something?
Answer.

A PLAN, cunning or otherwise.
Points.

1 point.
Question 12.

What 3 things does ISO 9001 expect of an individual when finding
something is awry?
Answer.

Establish what happened and why (record analysis)

Fix it now (corrective action)

Take steps to avoid it happening again (preventive action).
Points.

1 point for each of the above CAPA items. 1 extra
point for use of the word non-conformance.
Question 13.

What 3 things is your Quality Auditor looking for
when he or she speaks to you?
Answer.

Evidence that procedure is being followed

Helpfulness

Enthusiasm.
Points.

1 point for each.
Question 14.

What 3 things are likely to turn him or her off?
Answer.

Not being prepared

Not answering the question asked

Not helping.
Points.

1 point for each.
SCORING
RANGE
RATING
Over 25
Auditor
20-25
Human
10-19
Get Studying
Below 10
Stay at Home
Are you:
Materially ready?

Have we cleaned up all the corpses?
 Have we got good examples of work ready to show?
 Can we readily access our declared procedures?
 Can we recall their substance?
 Are our records up-to-date and accessible?
Are you:
Mentally ready?
 Relaxed?
 Positive?
 Helpful?
Preparing for the ISO 9001 Audit
 Tidy up
 Check you know your job (JD, processes)
 Familiarise yourself with the QMS
 Be ready to answer the obvious
 Don’t argue with the ref
 Be helpful, courteous and loyal to the cause
 Accept criticisms with grace and construction
 Stay cool