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