Chapter 11
Deviations

Purpose

  • To define the circumstances wherein a deviation from existing design criteria/documentation is acceptable.

Alternate Method

  • Do not allow deviations at all. If the engineer won’t write an ECO to the item design then rework to print, return to supplier or scrap the item (author preferred method).

Applicability

  • All deviations to design documentation as released or revised by this CM function.

Policy/Practice

  • Use only for a temporary departure from the design drawings and specifications — thus there is no need to change the design documents. If the design needs to change use the Change Form and procedure wherein a deviation is not allowed or required.
  • The deviation shall not be used as another way to make design changes.
  • Repeated deviations for the same problem usually means:
    1. The person designated to be responsible for “clearing” the earlier deviation did not/could not accomplish the task of fixing the root cause problem. That person should be consulted prior to writing another deviation for the same problem.
    2. The producer of the items involved does not understand the design criteria or does not have the latest criteria.
    3. A design change may be required. If so, go directly to the Change Form, do not write a deviation.
  • All deviations will be documented on the form shown on page 5 and signed by QA, ME and the cognizant design engineer.
  • Quality Assurance shall control the writing and approval of all deviation forms.
  • The deviation number of all deviations shall be posted in the revision block of the applicable drawing by CM (without writing an ECO) and a copy filed in CM. (Traceability – allows engineers in future troubleshooting to readily see the deviations.)
  • QA will place a form instruction online and/or on the back of the form (see the EDC Handbook).

Procedure

  • To be specified by QA.

Alternate Method

Do not allow deviations at all. If the engineer won’t write an ECO to the item design then rework to print, return to supplier or scrap the item (author preferred method).

Primary Responsibility

  • Quality Assurance will keep this standard current.
  • Quality assurance director may take exception to this standard by noting in the deviation what was done and why.

Authorization

Authorization
Deviation Form		 CM Manager
Deviation Authorization
(company name)
 DA#
Originator Name
Dept
 Date

Reason for Deviation:

Alternate Method

Do not allow deviations at all. If the engineer won’t write an ECO to the item design then rework to print, return to supplier or scrap the item.

Specific Time Frame or Serials to be Deviated
Product(s) Affected
P N Affected Documented Condition Deviated Condition
Name and Organization Responsible for Clearing This Deviation
Has This Condition Been Deviated Before? Yes □ No □
If So: DA # Date Time Frame or Units
QA Name Sign
Date
Mfg Engr Name
Sign
Date
Cog Engr Name
Sign
Date
Doc Control Name
Date Filed

Form # _____ If a design change is required, go directly to the ECO, do not write a deviation.

..................Content has been hidden....................

You can't read the all page of ebook, please click here login for view all page.
Reset