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Workbook · AQL-E13

Manufacturing Process Change Assessment

Assess every change to how a part is made or inspected before it reaches production: a risk screen, the customer's notice and approval, a validation plan with its criterion set first, the trial, the FAI, and a watch over the first lots, with every change on one log.

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Page 1 of the Manufacturing Process Change Assessment

Page 1 of the PDF. Every resource includes a fully worked example.

Part of the Configuration and Change Control Kit6 of 6← Supplier Change Notification Register

The problem it solves

Drawing changes come with paperwork; process changes often don't. A toolpath rewritten to save four minutes, an operation moved to a newer machine, a new fixture, a different deburr method: each one goes in because it is better, and nobody asks whether it touches a key characteristic, whether the customer's quality clauses ask to hear about it, whether an FAI is due, or how anyone will know it worked. This workbook puts every process change through the same short assessment before it reaches production, sets the acceptance criterion before the trial, and keeps the change open until the first lots have run clean.

Who uses it

Manufacturing engineers who make process changes, the quality engineers and managers who approve them, and production supervisors.

When

Open an assessment when anyone proposes a change to a machine, tool, fixture, program, method, sequence, material source, special process, location, inspection method or shift arrangement. Approve it before the first production part; close it after the watch.

Free to use, change and copy, in your own organization or with your clients; add your own logo, keep the Aegis credit. Part of: Configuration and Change Control Kit. Clause references: 8.5.6 (with 8.5.1, 8.5.1.3, 8.1) (numbers only; use your own licensed copy of the standard).

Aegis Insights inside. Wherever this resource gives our own guidance, it is labeled Aegis Insights, so you always know what is our experience and what a standard or your customer requires.

A management aid, not certification or a registrar audit. Using it does not by itself show conformity to AS9100D or any other standard.

How to put it to work

Chapters of our free guides that use this tool.

  1. The kit and how the tools connectThe FAI and Production Readiness Kit Handbook, chapter 2
  2. Three controls, one systemThe Configuration and Change Control Kit Handbook, chapter 2
  3. Order review and first article planning (D07)The FAI and Production Readiness Kit Handbook, chapter 6
  4. The kit at a glanceThe Configuration and Change Control Kit Handbook, chapter 3
  5. After approval: into steady productionThe FAI and Production Readiness Kit Handbook, chapter 14
  6. Who does whatThe Configuration and Change Control Kit Handbook, chapter 4

Related resources

  • Kit handbook

    The Configuration and Change Control Kit Handbook

    One working system for knowing exactly what each part is, changing it on purpose, and making sure every document and program on the floor says the same thing: configuration identification, customer, engineering and process change control, and documented information control, joined up.

    Word · PDFFree by email
  • Workbook

    Engineering Change Impact Assessment

    Assess every drawing, specification, order or engineering change before anything moves: twenty impact areas, effectivity and old-revision product, product safety, FAI, the customer question, every action to done, and a log of every change.

    Excel · PDFFree by email
  • Workbook

    Configuration Management Register

    Every part at its released configuration (drawing, specifications, router, programs, inspection plan, key characteristics and FAI, each with its revision), how it got there, and checks at the machine that what is built matches what is released.

    Excel · PDFFree download
  • Workbook

    Documented Information Control Register

    Every controlled document with its revision, approval, points of use and review date; every revision issued and whether the old copies came back; external documents checked against their source; spot checks where documents are used; and the records you keep and for how long.

    Excel · PDFFree download
  • Workbook

    Supplier Change Notification Register

    Log every change your suppliers make to site, process, source, material, people or ownership; check your purchase order and your customer's requirements; decide with a first article where needed; and verify the first lot made after the change.

    Excel · PDFFree download
  • Workbook

    Key Characteristics Monitoring Register

    Every key characteristic with its limits, control method and reaction plan; every measured value; and capability worked out from the values, so you know which KCs are capable, which are not, and which have too little data to say.

    Excel · PDFFree download

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These tools help you run the work by hand. When you want the whole picture of your quality system from the records you already keep, that's what the AeroAssure Audit Defense Pack and the IA9100 Transition Gap Analysis do.