Change Control

External Drawing Change Control

The Supplier must have a documented system for assuring that the latest Great Dane drawings (which have First Articles/PPAP approved by Great Dane) are in effect at their facility. 

Required Procedures

The Supplier’s Quality Manual must contain a written procedure that includes a description of the following:

• The method used for receipt, review, distribution, and implementation of all changes to drawings and specifications.
• The method used to contain new or modified parts until approved by the customer.

In addition, there must be a procedure for addressing and eliminating obsolete drawings and specifications, coupled with defining which current drawings must be in place at each location in the Supplier’s process. 

Internal Process & Engineering Change Control

Suppliers must have systems in place to control changes to drawings, specifications, processes, or produced products. Systems should be capable of handling changes being requested by the customer, and also changes requested by the Supplier.

The approval process is directed at a given part number for a specified revision level produced in a specific area of the manufacturer’s facility. Suppliers may not make any changes in their process, location, material, or to the product without written approval from the Great Dane SQE (or Quality designee). The Supplier must formally request a process change on all Great Dane materials, parts, or assemblies. 

Supplier Process Change Requests

Required Form

The Supplier must request changes to a released part, process, drawing, or specification using a Supplier Process Change Request (SPCR) (CORP5QA-007).

Great Dane encourages Supplier-initiated SPCRs with the stipulation that before an SPCR is submitted to the SQE (or Quality designee), the Supplier thoroughly reviews their FMEA and Control Plan to ensure that all process-related issues have been addressed and resolved. 

Components

The originator of an SPCR provides the following information:

• Drawing or part number
• Drawing or part title
• Description of problem or recommended change
• Reason for change or “rationale”
• Proposed effective date
• Signature of the originator 

Approval Process

The SCPR approval process is as follows:

1. The Supplier submits the Supplier-initiated SPCR with the revised FMEA (if applicable) and Control Plan to the responsible Great Dane SQE (or Quality designee) for evaluation of the following:▪ Supplier-demonstrated process capability and stability
   ▪ Comparison to First Article data
   ▪ Industry standards
   ▪ Supplier process engineering capabilities
   ▪ Supplier’s adherence to Supplier Control Plans
2. After the SQE (or Quality designee) has completed the review, and concurs with the Supplier, the SQE (or Quality designee) documents the request on the appropriate Great Dane engineering Change, First Article, etc.).
   
3. The request is processed through the appropriate Great Dane Purchasing personal for approval.
4. The SQE (or Quality designee) notifies the Supplier as to the final disposition of the SPCR and part submittal requirements and dates. 

Approval Identification

Any parts sent to Great Dane that have been approved on an SPCR must be clearly identified on the box, container, or other packaging methods with the appropriate SPCR number. 

Supplier Request for Deviation

Required Authorization

A Supplier is never permitted to knowingly ship product that deviates from the print, specification limits, or design intent without prior written authorization from the Great Dane SQE/R&D engineer (or Quality designee). If such a condition exists, the Supplier may petition the Great Dane SQE (or Quality designee) responsible for the item in question to allow shipment of the product under a signed written deviation from Great Dane. 

Testing

If directed by the Great Dane SQE /R&D engineer (or Quality designee), the Supplier must send samples of all nonconforming items to Great Dane for evaluation. The cost of any testing required in determining the acceptability of the product will be charged to the Supplier. 

Deviation Acceptance

Representatives from the applicable Great Dane organizations will determine the item’s acceptability and what actions (if any) are required beyond the deviation. The responsible Great Dane SQE (or Quality designee) will communicate this to the Supplier. The deviation is only intended to be an interim action and is not to be construed as an engineering change. The Supplier must begin work immediately to correct the condition in question within the time frame stated on the deviation. Failure to comply with the mutually-agreed-upon closure date for the deviation may result in the Supplier’s rating being affected. 

Containment

In all cases, the Supplier must fully contain all product suspected of being nonconforming at the Supplier location. In addition, the Supplier may be required to sort any suspect product at Great Dane or be charged back for any and all costs for this sorting.