Chapter 24
Change Control Policy

Purpose

  • To define the policy and practices required to process product design and documentation changes in a fast, accurate and well-understood fashion.
  • To specify the Change process work flow in flow diagrams for the three major phases of the change process (see attachments).

Applicability

  • Applies to all design changes from cognizant engineers related to this CM function after release of an item to Pilot Production or Production.
  • Not intended to apply to manufacturing process changes, marketing literature changes, or service/manual changes.
  • Does not apply when the product is in Design and Development Phase.

Policy/Practice

  • The change form must be used to release (see Release Standards) a new design document or item or to change a design document or an item, or to both release and change when the change requires a new item(s).
  • The change form shall be the only way to make changes to a design document or an item. Other forms, such as the Deviation, Waiver, Change Request, etc., shall not be used to make design changes. If redlining on the production floor is allowed, it must only be done by the Line-Down Change Standard.
  • Each change form is identified with a unique number assigned by CM normally after the Check Point is successfully passed. (Gives assurance to all affected that the change will be promptly released.)
  • The cross-functional team will be used to review certain requests and changes. See the applicable Team Standards.
  • Certain signatures are required per the Signatures Standard.
  • Those changes identified as “cost reductions” must have the cost calculated per the Costing Design Changes Standard.
  • After passing the “Design Complete” event, no changes to the technical aspects of the change, change form or attachments will be allowed. After that event, the change will be processed as is or canceled. Exceptions are allowed only per the “Primary Responsibility” of this standard.
  • All non-interchangeable changes must be modeled and tested on a production product. The VP of engineering must approve any exception to this rule.
  • One problem fix/improvement shall be delineated on one form with all necessary new or marked-up documents included in that change. No more than one problem/improvement will be included in one change. Multiple change forms for one problem/improvement will not be allowed. Exceptions to these rules are as follows:
    1. Software or firmware changes (not dependent upon any hardware changes) may be combined into logical groupings and tested and “released” as a group.
    2. Several “Document Only” changes to the same document may be combined into one change. Such changes may be “queued” (held for the next document-only change) only by the cognizant engineer.
    3. Several interchangeable changes to the same item providing they can be made effective together. Such changes may be “queued” (held for the next change) only by the cognizant engineer.
    4. Short-term fix and long-term fix may be on two change forms with the short-term fix done now and the long-term fix done later.
    5. This policy allows for a fix to be done across the product line or across a document type by a “blanket” change form. Blankets will normally be done in hard copy offline so that they do not affect the thru-put time measurement or the aged reports.
  • Use of marked prints is required in all cases except where the change can be fully detailed by “From-To” delineation in the space for “Description of Change” in hard copy box (see Mark Up of Design Documents Standard).
  • Use of CAD “overlays” or “redlines” or word processing “redlining” techniques is encouraged instead of hand mark up.
  • The Change Request number or other reference numbers should be shown on the change form, but such documents need not be included in the change package.
  • If unique rework (other than “Rework to Print”) configurations are allowed, they should be included in the change package before the “Design Complete” event.
  • New part, assembly or related documents required as part of the change must be included in the change package.
  • All affected documents must be included in the change package — revised pages only.
  • The impacted functions will be determined by and per the Impacted/Affected by a Change Standard.
  • Masters of change documents (online or hard copy) will be controlled, and kept by the cognizant engineer prior to “Design Complete” and by CM afterward. They will be available for review by any interested party. After release to Manufacturing they will be filed by the change form number in/by CM.
  • The source of the used on / where used will be the ERP BOM database.
  • Add any policy statements required as a result of ERP or PLM system design here.
  • The change system phases are defined as follows:
    1. Design (Redesign) Phase – From “Start” to “Design Complete”.
    2. CM Phase – From “Design Complete” to “Release to Manufacture” — the latter of ERP Updated or Master Documents Updated.
    3. Implementation Phase – From “Release to Close”.
  • The company goal for the average processing time through the CM phase is five workdays.
  • Time limits for performing certain functions including signatures are: (add your own time limit standard)
  • The originator of the request, change or any other party that believes that the change must be expedited, may walk to/email/telephone those involved in the process to accomplish this. CM will not hand-carry or expedite any given change but will expedite the whole of changes.
  • Problems encountered during the processing should be brought to the attention of the responsible CM technician.

Procedure

  • See the flow diagrams attached.

Primary Responsibility

  • The CM function is responsible for maintenance of this standard in a current condition.
  • The CM manager may take exception to this standard on any given change by noting the reason(s) for exception on the applicable change form.
  • CM will maintain the workflow diagrams.

Authorization

Authorization

VP Engineering

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