Design and Process Change Management
Requirements
The Seller shall notify the Buyer within 30 days of incorporating a “major design or process change.” Buyer is responsible for submitting design changes to the Federal Aviation Administration (FAA) Aircraft Certification Office (ACO), or their authorized designee, to obtain FAA approval. Major changes to Parts Manufacturing Approval (PMA) articles shall not be incorporated in production before receiving FAA approval through the Buyer.
The Seller has the authority to process and implement “minor design or process changes.” The Seller shall summarize “minor design or process changes” and send them to the Buyer on the first day of each quarter through the duration of the contract. The summary should include:
- Part number.
- A detailed summary of the changes, including page numbers and a was/is analysis.
- Document name or identifier.
The Seller’s First Article Inspection (FAI) shall serve as the design and process baseline. Once engineering and process baselines are established, the Seller shall control changes to both the engineering and process baselines.
Buyer defines changes as follows.
Major Design or Process Changes
A change that affects the fit, form, or function of an article. These changes affect the product specifications, weight, interchangeability, interfacing, reliability, safety, schedule, cost, and supportability of an article. Common “changes” include:
- Changing the location of the internal or external site where some or all of the work is being performed, including the movement of the production line equipment.
- Any change in the manufacturing process that changes or alters the configuration, composition, or physical properties of the item produced.
- Adding or removing any material to the article that is not called out in the baselined manufacturing or engineering documentation.
- Changes to acceptance test procedure(s).
- Changing the functional capabilities and purpose of test equipment.
- “Major change” in the Seller subcontractor’s process, tooling, or engineering.
- Changing the source of material, sub-component, or outsourced operation.
- A change, after the establishment of the baseline for the product design that affects compatibility with interfacing products, including equipment, software, or that affects one or more of the following:
- Delivered operation or servicing manuals.
- Required calibration to the extent that product identification should be changed.
- Interchangeability or substitutability of replaceable products, assemblies, or components.
- Operator or maintenance training.
- Changes that require retrofit, product recalls modifications of the delivered product.
Minor Design or Process Changes
A change to correct documentation or changes to hardware not otherwise defined as a “major change.” “Minor changes” have no appreciable effect on the approval basis of the part. Typical examples include:
- Engineering
- Changing the sequence of an operation.
- Changes in any machine programming.
- Changing to new or alternate production line machines or equipment.
- Changes to qualified inspection techniques or equipment.
- Changing attributes of the test equipment that does not affect the functional capabilities and purpose of test equipment.
- Using different types of tools to produce the item on this purchase order.
- General
- Corrections to spelling and grammar errors.
- Correcting typographical errors.
- Adding or deleting non-directive (reference) photos.
- Adding cautionary (personnel/hardware protection) notes.
- Updating document format.
- Improvements in clarity or brevity
- Processes that do not affect the form, fit or function of the part.
- Additions and/or subtractions of supplier information from the drawing.
- Clarification of dimensions or tolerances.
- Supplier Management
- Adding a new sub-tier supplier to produce a part.
- Minor change in sub-tier supplier’s process, tooling, or engineering.
QC255 - Design and Process Change Management
Effective: 12/1/2020
Reliable Robotics Corporation