[Company Name]

[Company Group, Division, Location]

Document Title: Interim Changes

Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Interim Changes
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

Table of Contents...................................................................................................................................................1

1.0 Purpose..............................................................................................................................................................2

2.0 Scope.................................................................................................................................................................2

3.0 Definition Of Terms..........................................................................................................................................2

3.1 Interim Change.......................................................................................................................................2
3.2 Document 2
3.2.1 Organizational Document.........................................................................................................2
3.2.2 Production Document...............................................................................................................2
3.3 Engineering Release...............................................................................................................................2
3.4 Production Release.................................................................................................................................2

4.0 References.........................................................................................................................................................2

5.0 Responsibilities and Requirements...................................................................................................................2

5.1 Technical Support Services....................................................................................................................2
5.2 Interim Change Originator.....................................................................................................................3
5.3 Manufacturing Engineering....................................................................................................................3
5.4 Engineering.............................................................................................................................................3
5.5 Quality Assurance..................................................................................................................................3

6.0 Procedure...........................................................................................................................................................3
6.1 Description 3
6.2 Origination 3
6.3 Interim Change Notice Requirements....................................................................................................3
6.3.1 Type of Change........................................................................................................................3
6.3.2 History of ICN..........................................................................................................................3
6.3.3 Effective Range........................................................................................................................3
6.4 Approval 4
6.5 Completed ICNs.....................................................................................................................................4
6.5.1 Technical Support Services......................................................................................................4
6.5.2 Manufacturing Engineering......................................................................................................4
6.5.3 Quality Assurance.....................................................................................................................4

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[Company Name] Interim Changes
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
The purpose of this procedure is to establish a system for approving deviations from released product
documentation at [Company Name].

2.0 Scope
This procedure applies to all products built to released production documents of [Company Name]. It
does not apply to items that are manufactured to documentation that has not been released through
Production Document Release and Change Control.

This procedure also does not apply to organizational documentation.

3.0 Definition Of Terms

3.1 Interim Change

An interim change is an approved temporary deviation from an authorized document, process, or
configuration. These are only applicable for a period of time or number of units that is
determined at time of approval. The actual product documentation is not changed by an interim
change.

3.2 Document
A document is any written, printed, or electronic record. Documents include, but are not limited
to the following examples: drawings, specifications, blueprints, procedures, and work
instructions.

3.2.1 Organizational Document

An organizational document is a general business document, either interdepartmental or
intradepartmental, which defines organizational operations not directly related to
product manufacture.

3.2.2 Production Document

A production document is a document directly related to the manufacturing process that
describes either the product itself or processes directly related to the manufacture of the
product. Production documents include design documents and process documents and
follow a very structured system of revision control.

3.3 Engineering Release

Engineering release is the initial release phase of a document submitted to Documentation.
Although design authority of an engineering release remains with the originating department,
any document released for engineering release is subject to change control procedures.
Engineering releases follow a simplified change control process.

3.4 Production Release

Production release is the second release phase of a document based on a decision that the
document is ready to be released for production. In addition to the approval of the originating
department, production releases also require the approval of the counterpart in either
Engineering or Manufacturing Engineering, as well as Quality Assurance.

4.0 References
Interim Change Notice

5.0 Responsibilities and Requirements

5.1 Technical Support Services

Technical Support Services is responsible for logging and maintaining approved interim
changes.

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[Company Name] Interim Changes
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

5.2 Interim Change Originator

The interim change originator is responsible for preparing the Interim Change Notice and
providing the change approvers with sufficient information to effectively analyze the change.

5.3 Manufacturing Engineering

Manufacturing Engineering is responsible for evaluating and approving interim changes. It also
is responsible, when applicable, for implementing approved interim changes and for
documenting that implementation into finished product.

5.4 Engineering
Engineering is responsible for evaluating and approving interim changes.

5.5 Quality Assurance

Quality Assurance is responsible for evaluating and approving interim changes. It also is
responsible, when applicable, for verifying that interim changes are correctly implemented and
for ensuring that implementation is recorded in the product's Device History File (DHF).

6.0 Procedure

6.1 Description
An interim change is an approved temporary deviation from an authorized document, process or
configuration. After a specific time frame or a specific number of items, the intent is to return to
the specified design. Interim changes may be used for both engineering and production releases.

An interim change may be used in the following circumstances:

• to use a functionally equivalent part as substitute for a specified part

• to use a different part or process for verification or validation
• to use a different part or process for experimental testing. An interim change should not be
used to change the design or its documentation.

6.2 Origination
An Interim Change Notice (ICN) may be originated by individuals in Engineering,
Manufacturing Engineering, or Quality Assurance. The originator of the interim change notice is
responsible for describing the interim change and for providing sufficient information to the
approvers so that the change may be effectively analyzed.

6.3 Interim Change Notice Requirements

6.3.1 Type of Change

All Interim Changes should be appropriately identified by type: functional equivalent;
verification/validation; or testing. If an interim change is used either for
verification/validation or testing, a technical report should be written following the
completion of verification/validation or testing.

6.3.2 History of ICN

The originator should identify whether or not an ICN is new or the continuation of a
previously written ICN. If an ICN is a continuation, this may be an indication that the
change should be made permanent through an Engineering Change Notice (ECN).

6.3.3 Effective Range

The originator should identify the effective range of the ICN. This range may be
identified either by date or serial numbers. Both ends of the ranges must be specified.
An ICN should not be open ended.

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[Company Name] Interim Changes
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

If serial numbers are used, individual serial numbers may be used instead of a range if
the numbers do not fall sequentially.

6.4 Approval
The appropriate managers in Engineering, Manufacturing Engineering, or Quality Assurance,
whether written against documents at engineering release or production release, must approve all
interim changes.

Once approved by all departments, the originator should forward the signed Interim Change
Notice to Technical Support Services. Technical Support Services will verify signatures, assign
an Interim Change Notice number, and record the Interim Change Notice approval into its
Change Tracking System. Following Interim Change Notice number assignment, Technical
Support Services also will provide copies of the approved ICN to Engineering, Manufacturing
Engineering, and Quality Assurance.

No Interim Change Notice should be considered complete without Interim Change Notice
number assignment.

6.5 Completed ICNs

6.5.1 Technical Support Services

Following the entry of an approved Interim Change Notice into the Change Tracking
System, the assignment of n ICN number, and the distribution of appropriate copies,
Technical Support Services involvement in a particular ICN is complete.

Since no permanent changes have been approved, no documents will be revised, and no
entry of the ICN will be made.

6.5.2 Manufacturing Engineering

Following the completion of an approved Interim Change Notice, Manufacturing
Engineering is responsible, when applicable, for implementing approved interim
changes and for documenting that implementation into finished product.

6.5.3 Quality Assurance

Following the entry of an approved Interim Change Notice, Quality Assurance is
responsible, when applicable, for verifying that interim changes are correctly
implemented and for ensuring that implementation is recorded in the product's Device
History File (DHF).

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