Module 1 : Identify Team Members
Module 2 : Describing the Problem
- Problem Statement
- Description of customer observations and information
- Product item number or device information
- Production order #, batch or lot #, [customer PO or delivery]
- When & where the problem was observed or encountered
- Incoming QC, production line QC, final QC
- Description of failure mode
- Include photo’s or other data received from customer
- Failure rate if available
- Qty of pieces defective, affected lot qty, etc
- Is/Is Not Analysis
Module 3 : Developing an Interim Containment Action
- Verification & Validation of 'Interim Containment Action'
- Explain the actions for containment of the problem
- List goals and dates of actions taken to contain the problem
- Potential inventory locations
- Pending material from supplier
- Material in transit to customer
- Material under consignment
- Material at customer location
- List the actions taken at each inventory location. Describe actions based on initial problem investigation
- List target and actual dates for completion
- List short containment actions
- Short Term - Temporary actions to contain the problem and “fix” until permanent correction is in place. (Note: Validate that the action taken works)
- Determine if containment is required at the customer
- The Quality Alert and training record can be attached later.
Module 4 : Defining and Verifying the Root Cause and Escape Point
- Process Mapping to find 'Escape Point'
- 'Theory' Development
- Cause & Effect Analysis
- Verification of Root Cause
- Clearly define the root cause based on an investigation of the problem
- State facts only (Do not provide unclear information)
- How To Complete 5 Whys
Module 5 : Define & Implement Corrective Action
- Mistake Proofing
- Risk Analysis & Verification of 'Permanent Corrective Action'
- Define the Corrective Action Plan
- List the goals and actions that are required
- List what organizations have responsibility
- (optional)
- List the due and completion dates
- List the results of the corrective action
- List the verification of corrective action
- Define the corrective action taken to prevent recurrence which eliminates the cause of detected nonconformance.
- Corrective and preventive action to overcome ‘escape point’
Module 6 : Define & Implement Preventive Action
- Action Planning
- Contingency Planning
- Validation of 'Permanent Corrective Action'
- List the action taken to prevent a problem from occurring, based on an understanding of the product or process.
- Preventive Action to eliminate the cause of a potential nonconformance
- Can be more than one cause
- Preventive action must address inadequate "conditions" which may produce non-conformances
- List the goals and actions that are required
- List the due and completion dates
- Implement and validate to ensure that corrective action does “what it is supposed to do.” Detect any undesirable side effects
Module 7 :Verify Completion & Effectiveness
- Audit the process to ensure the plan was implemented - Provide audit results
- List all documentation of the process reviewed to ensure effectiveness
- Include specifications and output results
- Include training records completed
- Include ECO / ECR History
- Include doc number & information change form
- SPC and or other objective evidence documenting before and after
- Qualification and or validation plan results
- before and after
Module 8 : Recognizing Contributions of the Team and Individuals
