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Techniques for ISO 9001 Implementation

Learn how to avoid trouble in ISO 9001 implementation by addressing common hazards and challenges. Get tips on management buy-in, employee engagement, and documentation practices.

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Techniques for ISO 9001 Implementation

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

  2. Diving In Hazards Winning the Race Continuing Workouts

  3. Diving In Over coming fear of the water.

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

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

  6. Diving In 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

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

  8. Diving In 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?

  9. Diving In 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.

  10. Diving In 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?”

  11. Diving In 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.

  12. Hazards Watch out for Hazards:

  13. Hazards 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.

  14. Hazards 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.

  15. What to Do 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

  16. Hazards 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”

  17. Hazards 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”

  18. What to Do 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.

  19. Hazards DocumentationToo 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.

  20. What to Do 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.

  21. Hazards 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.

  22. What to Do 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.

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

  24. What to Do 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

  25. Hazards 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.

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

  27. Hazards 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

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

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

  30. Winning the race Registration

  31. Winning the race 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.

  32. Winning the race 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.

  33. Going the distance

  34. Going the Distance 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.

  35. Going the Distance 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.

  36. Going the Distance 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?

  37. Going the Distance 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.

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

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

  40. Going the Distance 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.

  41. Going the Distance 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

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

  43. Enjoy Your Success!

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