2. Techniques for ISO 9001 Implementation How to avoid trouble in ISO 9001 Implementation.

3. Diving In Hazards Winning the Race Continuing Workouts

4. Diving In Over coming fear of the water.

5. It is too cold! No one wants to jump into a cold, empty pool. Diving In

6. . Management must make sure the water is warm. Managers: Get in first. Commit to the project, and make your commitment visible. Diving In

7. Management: Get in first by….. –Learning about ISO –Planning the project and assigning responsibilities Make your commitment visible by….. –Providing resources –Rewarding participation in the ISO project Diving In

8. Management These points may seem obvious - but the biggest obstacle quoted by a registrar is: Diving In Management buy-in and support

9. Management has prepared the way, and yet many still don’t want to dive in.. I’m happy where I am, why should I do anything different? Diving In

10. Make the water inviting People won’t want to get in on the project unless they know what it means to them and to their job. –Explain why ISO is important to the company –Explain how it will make their job easier. –Explain how their job will be different –And how it will be the same. Diving In

11. Understand that employees may feel threatened. “If I document everything I do, will I still have value?” “What is this corrective action? It sounds like going to the principals office.” “Someone is going to audit my performance?” Diving In

12. Remove the threat Involve employees in the development process. –To modify or develop processes to meet the standard use the people that are currently involved in the process. –Train all staff on the corrective action and internal audits; emphasize the focus on improving the process. Diving In

13. Watch out for Hazards: Hazards

14. The company doesn’t know how to swim Provide swimming lessons A general introduction to ISO 9001 is necessary for all staff. Consider more advanced training for the project manager and other people driving the project. Hazards

15. Misinterpretation of the Standard Leads to wasted efforts and time. –Having to redesign processes numerous times. –Over Implementing the standard - requiring too much in your system. –Uncovering major nonconformances during your audit, delaying your registration. Hazards

16. Use a coach Consider using a consultant. –To help plan your project –To help interpret the standard –To allow you to benefit from experience –To watch your timeline What to Do

17. Drowning in Detail….. “The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible” Hazards

18. And poorly written procedures Why use ten words when one will do? –“The items hereinunder referenced in some cases fell excessively outside normal parameters.” –“The procedures contained herin are applicable to all operations in the following departments within their functional ambit” Hazards

19. Make procedures user friendly Use short sentences starting with a verb. Avoid using the passive voice. Make it clear who is performing the task. Use white space for easy reading. What to Do

20. Documentation Too Much? Too Little? Too Much: –Work instructions written for virtually everything –Overlap and repetition - Including a process in more than one work instruction. Too little: –Lack of work instructions where the process affects the quality of the product. Hazards

21. Documentation Remember that the goal here is consistency for your processes. If two trained employees were to perform this task, would they do it the same way? If the answer to this is “Maybe not” a work instruction is appropriate. What to Do

22. Departments that are “Different” Do you have a department that needs “artistic license” to do their work? You may encounter some resistance to documenting procedures in these areas. Hazards

23. Help them see how the procedure can work for them. It is important to demonstrate to these departments that the process should be consistent. The creativity takes place within the process. Document the procedure to describe the steps that must be followed, but not to prescribe the detail of their job. What to Do

24. Your project gets out of control Teams are not meeting the timeline. Overlapping processes are not coordinated. Teams are going in different directions. Hazards

25. Use a steering team Have decision makers and resource providers on the team. The team must: –Monitor the timeline –Remove obstacles –Provide resources –Coordinate efforts between different groups What to Do

26. Employees are not aware of progress. As the project goes on, employees hear less and less about progress. –Only those involved are aware of new processes. –It appears as though the project has come and gone. –New processes are only documents, not a change in practice. Hazards

27. Celebrate Involve employees and keep the project visible by celebrating progress and success. –Get togethers –Food –Employee recognition –Newsletters to communicate What to Do

28. Someone removed from the process is writing procedures. The procedure is unrealistic. It will not be successfully implemented. –The procedure is idealistic, not practical –The procedure has failed to address key issues for the process –The opportunity to address difficulties in the process Hazards

29. And the usual suspects Purchasing Corrective Action Document Control Training Design Control Hazards

30. The usual nonconformances: Design Control Document Control Purchasing. Equipment. Corrective Action Training Hazards

31. Winning the race Registration

32. Be prepared for your audit: Complete one cycle of internal audits. Complete one management review. Have approximately 3 months of records. Have a minimum of one design project documented start to finish. Winning the race

33. Be prepared for your audit: Make all employees aware of the audit. Let them know what to expect. Do a “Sweep” of your facility for uncalibrated equipment and uncontrolled documents. Winning the race

34. Going the distance

35. Are you swimming or treading water? The system is too complicated, and becomes static. –The system may have been built as the ideal system, not a reflection of what is actually done. –Employees become stalled, confused. Going the Distance

36. Simplify Don’t be afraid to make changes to the system. Simplify the procedures. –Don’t expect the system to be perfect immediately. –Get feedback from employees involved with the process to make changes. Going the Distance

37. Is Management Review Effective? Management review becomes ineffective –Evaluate the data that is provided. Is it enough to communicate to management how the quality system is working? –Is management assigning action items and following up on them? –Is management devoting enough time to management review? Going the Distance

38. Are Internal Audits Effective? Internal audits become ineffective –Is management committed? –Are employees available for the audit? Auditees Auditors –Is it always the same person auditing? It may be time for a change, new people mean new perspectives. Going the Distance

39. Follow the example of experienced swimmers Workout Never swim alone Follow the Rules Going the Distance

40. Workout Use the system that you have built. Implement corrective actions. Emphasize the importance of Corrective Action Management Review Internal Audits Continue training. Going the Distance

41. Never swim alone The system cannot be the responsibility of one person. –Assign responsibilities to a variety of people Don’t assume that the Quality Manager has to be responsible for everything. –Use others as coordinators for Corrective action, Training Records, Equipment, Quality Records and Internal Audits. Going the Distance

42. Follow the Rules Keep the water warm Management must get in first Provide swimming lessons Use a coach Make procedures user friendly Include “creative” departments Use a steering team Going the Distance

43. Follow the Rules Celebrate and communicate Involve the people performing the process Watch out for the usual nonconformances Prepare for your audit Going the Distance

44. Enjoy Your Success!