Supplier requirements for managing key characteristics
If Key Characteristics (KCs) have been identified on the Technical Data Package (TDP) for this Purchase Order, are identified in the Supplier Instruction Sheet or Stamp Package (SIS/STAMP), or were identified during the Pre-Work Authorization Review (PWAR) and/or Post Award Review, the Supplier is required to do the following:
- Identify the Key Processes that affect the KCs identified.
- Develop, document, and implement a Process Control for all Key Processes (see Process Control Plan below for an example). Note: To use the Process Control Plan below, fill in the information required in the green highlighted sections of the plan.
- The Process Control Plan shall:
- Implement a method for statistical monitoring of identified Key Processes (The Supplier shall include justification when the application of statistical techniques would be a non-value added task (High Cpk values) and where the application of Statistical Process Control techniques is deemed impractical. Alternative methods of process control must be evaluated in such cases.)
- Require review and approval by both Clear Align and the Supplier
- Document how each Key Process that affects a KC will be monitored and controlled
- List all Key Processes that are being offloaded and how they will be controlled and monitored at the sub tier.
Clear Align shall conduct reviews at the Supplier’s facility to review the Key Processes and to verify the implementation of the Supplier’s Process Control Plan.
At the Supplier’s request, Clear Align will provide assistance to bring the Supplier into minimum compliance with this Quality Attachment. Measurement or performance data pertaining to all key process parameters that are correlated with identified key quality characteristics shall be maintained by the Supplier and made available upon request in a timely manner to RMS.
Clear Align/Supplier’s Name Control Plan
1.1 Objective: Develop a plan for controlling the Key Processes that control the Key Characteristics (KCs) of the Clear Align part numbers supplied by Supplier’s Name.
1.1.2 The following are the conditions that require a review/revision to this plan:
22.214.171.124 A change to facility/processing equipment that affects a Key Process listed in Appendix A: A facility/processing equipment change is a change in or to tools, test equipment, measuring or aligning fixtures, processing tanks, equipment, machinery, machine set-ups, or other plant manufacturing equipment, etc., used to manufacture, process, assemble, inspect and/or test the item.
126.96.36.199 A change to a procedure(s) that affects a Key Process listed in Appendix A: A procedure change is a change in or to the methods, procedures, planning and/or sequencing used in or applicable to the manufacturing, processing, assembly, inspection and/or test of the item.
188.8.131.52 A change in location: A change in location is a change of the site where some or all of the work on items is being performed. It may be as little as moving an assembly line, and it may or may not involve a change in facilities, procedures, personnel and/or processing sources.
184.108.40.206 A change in the source or processing that affects a Key Process listed in Appendix A: A change in the source or processing includes such changes that may be from an outside processing source to within the Seller's facility, from within the Seller's facility to an outside processing source, or from one outside processing source to another.
220.127.116.11 A Deviation, Waiver, or engineering change which affects a Key Process listed in Appendix A:
18.104.22.168 List any other reasons for review/revision to Process Control Plan.
2. Responsibilities *Clear Align and Supplier’s Name will maintain a list of the names of the individuals that hold the titles below along with phone numbers, email addresses, and fax numbers for each.
1. Supplier’s Name Responsibilities:
2. Title of the Person is responsible for ensuring the activities required by the Process Control Plan are planned, implemented, controlled, and their progress monitored at Supplier’s Name.
3. Title of the Person is responsible for communicating the requirements of the Process Control Plan to all affected Departments, Subcontractors, and Suppliers, and is also responsible for contacting the Clear Align Buyer when any problems arise in meeting the requirements of the Process Control Plan.
4. Title of the Person is responsible for reviewing the results of audits performed by Clear Align at Supplier’s Name and for obtaining cause and corrective action for any findings.
3. Clear Align Responsibilities:
1. The Supplier Quality Engineer for the part(s) covered by this Process Control Plan is responsible for ensuring the activities required by the Plan are planned, implemented, controlled, and their progress monitored at Clear Align.
2. The Supplier Quality Engineer for the part(s) covered by this Process Control Plan is responsible for communicating the requirements of the Plan to all affected Departments, Subcontractors, and Suppliers, and is also responsible for ensuring any problems that arise in meeting this Plan are resolved.
3. The Supplier Quality Engineer and/or the Field Engineer for the part(s) covered by this Process Control Plan are responsible for conducting any audits that are required by it, issuing a Supplier Corrective Action Request (SCAR) for any findings and for reviewing and accepting/rejecting Supplier’s Name responses to any SCARs issued.
4. Process Control Plan Review
1. This Process Control Plan will be reviewed when?
2. It will be reviewed by whom?
3. Any changes made during the review of the Process Control Plan must be approved by whom?
4. Conflicts or ambiguities in requirements will be resolved by how?
5. Key Characteristics and Key Process Control
5.1.2 Clear Align shall monitor the Key Processes identified in Appendix A as follows:
22.214.171.124 A Product/Process Verification (PPV) audit done by the Clear Align Field Engineer or designateevery enter frequency.
5.1.3 Supplier’s name shall monitor the Key Processes identified in Appendix A as follows:
5.1.4 Enter how the Supplier monitors the Key Processes
6. How Key Processes Being Off-Loaded to Sub-Tier Suppliers will be Controlled and Monitored 6.1.2 The following will be off-loaded to sub-tier Suppliers and will be controlled/monitored by Supplier Name as follows: 6.1.3 Describe
7. Clear Align quality requirements will be flowed down to Supplier’s Name sub-tier Suppliers as follows: