Corrective Action
In this section
This section is divided into the following subsections
7.2
Required Pallets
ELEMENT
DESCRIPTION
1. Use Team Approach and immediately contain any suspect product
Immediate containment of any suspect product and suspension of production, if warranted. Action plan for team formation.
2. Describe the problem
Process flow diagram to define the process. Control charts to indicate special causes. Check sheets to define “what, when, where, who, how, and how much”. Action plan to coordinate problem definition actions.
3. Implement and verify interim (containment) actions
Check sheets to evaluate the effectiveness of actions. Control charts and histograms with intensive sampling for process monitoring. Action plan to coordinate interim fixes.
4. Define and verify root cause(s)
Why manufacturing process produced nonconformance Why nonconformance was not detected Identify Potential Causes – Brainstorming for potential causes. 5 WHYs Cause-and-effect diagrams to identify and organize potential causes. Failure mode and effects analysis (FMEA) to identify potential causes of observed failure mode.
Analyze Potential Causes
Check sheet to collect data. Designed experiments, statistical analysis of data. Comparison plots, histograms, and stratified graphs to evaluate stratification factors of different process or product parameters. Scatter plots to evaluate relationships between characteristics. Gage studies to evaluate the measurement system. Action plan to manage analysis steps.
Validate Root Causes
Comparison plots, histograms, and stratified graphs to validate cause. Stratified graphs to validate presence of root cause factors. Action plan to manage validation actions.
Identify Alternate Solutions
Alternate solution Cause-and-effect diagram.
5. Implement permanent corrective actions
Control charts and check sheets to monitor process performance. Control plan, process documentation update.
6. Verify effectiveness of permanent corrective action
Control charts and histograms to evaluate process stability and capability.
Check sheets to collect product or process evaluation information.
7. Prevent recurrence
Action plan to coordinate required changes.
Evaluate other areas where the problem could also occur. FMEA update.
8. Closed by a higher authority
7.3
When Issued
The Great Dane SQE (or Quality designee) issues a Supplier Lean Alert via email to the Supplier when nonconforming material, parts, or assemblies are found at any of the following:
- Receiving Inspection
- In production
- In test
- In audit
- By a Great Dane customer
Required Response
Within 72 hours from initial notification, the Supplier is required to respond by e-mailing the Lean Alert back to the SQE (or Quality designee) with the following:
- Initial Observation, the Containment, the Supplier “Root Cause” Investigation, and the Corrective Actions fields completed.
- Dates and Supplier contact.
The Supplier is required to respond as defined in the table below.
REQUIRED ACTION
TIMELINE
The Containment Plan must clearly define the containment actions at the Supplier’s facility, to assure that no nonconforming product is shipped to Great Dane. The Supplier must:
- Address all suspect stock in transit, and any stock at any Great Dane facilities.
- Specify what actions are to be taken.
- Must bound the problem by identifying all suspect lot numbers and associated quantities involved.
- The supplier must cover all sorting and additional transportation costs (Sort on-site or return to Supplier)
Supplier must report the results of the Supplier’s investigation into the cause of the problem.
Within 7 days from initial notification date
The supplier must submit the Permanent Corrective Action to be taken to prevent the recurrence of the problem, and the effective date (the date the Corrective Action will be implemented.).
Train (or discipline) the operator; increase inspection, and the like are not acceptable corrective actions
Within 15 days from the initial notification date.
The supplier must keep Great Dane informed of progress towards implementing the Corrective Action.
Ongoing
Supplier and Great Dane SQE (or Quality designee) verify that the Corrective Action is effective in correcting the problem. The Great Dane SQE (or Quality designee) then closes out the Supplier Lean Alert.
When the Corrective Action implementation is complete