Techniques for ISO 9000 Implementation

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Techniques for ISO 9000 Implementation

• How to avoid trouble in ISO 9000 Implementation.

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• Diving In
• Hazards in the Water
• Winning the Race
• Continuing Workouts

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Diving In

• Over coming fear of the water.

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It is too cold!
Diving In

• No one wants to jump into a cold, empty pool.

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Management must make sure the water is warm.
Diving In

• Managers Get in first.
• Commit to the project, and make your commitment
  visible.

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Management
Diving In

• 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

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Management
Diving In

• These points may seem obvious - but the biggest
  obstacle quoted by a registrar is
  

Management buy-in and support
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Management has prepared the way, and yet many
still dont want to dive in..
Diving In

• Im happy where I am, why should I do anything
  different?

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Make the water inviting
Diving In

• People wont 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.

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Understand that employees may feel threatened.
Diving In

• 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?

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Remove the threat
Diving In

• 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.

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Watch out for hazards in the water
Hazards in the water
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The company doesnt know how to swim
Hazards in the water

• Provide swimming lessons
• A general introduction to ISO 9000 is necessary
  for all staff.
  
• Consider more advanced training for the project
  manager and other people driving the project.

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Misinterpretation of the Standard
Hazards in the water

• 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.
  

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Use a coach
Lifesaving Technique

• 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

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Drowning in Detail..
Hazards in the water

• 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

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And poorly written procedures
Hazards in the water

• 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

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Make procedures user friendly
Lifesaving Technique

• 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.

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DocumentationToo Much? Too Little?
Hazards in the water

• 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.

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Documentation
Lifesaving Technique

• 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.

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Departments that are Different
Hazards in the water

• Do you have a department that needs artistic
  license to do their work?
  
• You may encounter some resistance to documenting
  procedures in these areas.

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Help them see how the procedure can work for them.
Lifesaving Technique

• 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.

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Your project gets out of control
Hazards in the water

• Teams are not meeting the timeline.
• Overlapping processes are not coordinated.
• Teams are going in different directions.

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Use a steering team
Lifesaving Technique

• Have decision makers and resource providers on
  the team.
  
• The team must
• Monitor the timeline
• Remove obstacles
• Provide resources
• Coordinate efforts between different groups

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Employees are not aware of progress.
Hazards in the water

• 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.

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Celebrate
Lifesaving Technique

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

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Someone removed from the process is writing
procedures.
Hazards in the water

• 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

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And the usual suspects
Hazards in the water
Corrective Action
Document Control
Design Control
Training
Purchasing
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The usual nonconformances
Hazards in the water

• Design Control

• Document Control

• Purchasing

.

• Equipment

.

• Corrective Action

• Training

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Winning the race

• Registration

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Be prepared for your audit
Winning the race

• 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.

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Be prepared for your audit
Winning the race

• 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.
  

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Going the distance
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Are you swimming or treading water?
Going the Distance

• 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.

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Simplify
Going the Distance

• Dont be afraid to make changes to the system.
  Simplify the procedures.
  
• Dont expect the system to be perfect
  immediately.
  
• Get feedback from employees involved with the
  process to make changes.

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Is Management Review Effective?
Going the Distance

• 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?

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Are Internal Audits Effective?
Going the Distance

• 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.

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Follow the example of experienced swimmers
Going the Distance

• Workout
• Never swim alone
• Follow the Rules

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Workout
Going the Distance

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

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Never swim alone
Going the Distance

• The system cannot be the responsibility of one
  person.
  
• Assign responsibilities to a variety of people
• Dont 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.

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Follow the Rules
Going the Distance

• 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

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Follow the Rules
Going the Distance

• Celebrate and communicate
• Involve the people performing the process
• Watch out for the usual nonconformances
• Prepare for your audit

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Enjoy Your Success!