RADITEK INC.

Document Number 4.05 P2 Rev. E

Procedure ECN Processing

Title: Procedure ECN Processing

ISO Element: 4.05
Doc. Number: 4.05-P2
Rev: E

REVISION HISTORY
REV DESCRIPTION ORIG. APPROVED DATE
A Released Peter Corbett 02/14/98
B Update Craig Madsen Peter Corbett 04/12/08
C Update Craig Madsen Peter Corbett 05/21/09
D Update Craig Madsen Peter Corbett 04/14/10
E Update Craig Madsen Peter Corbett 05/16/14

Signature Date
Originator Peter Corbett 02/14/98
Manager
Additional approval

This document is maintained only on the Raditek Network.

Any printed version is valid for 2 days from the date shown below.

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RADITEK INC.

Document Number 4.05 P2 Rev. E

Procedure ECN Processing

1.0 PURPOSE
To define the methods used to process Engineering Change Notices at Raditek.

2.0 SCOPE
2.1 This procedure applies to releasing and changing Raditek Production Documents,
Procedures, Specifications and Standards relating to Engineering, Manufacturing,
Marketing, Purchasing and Quality.

2.2 This procedure excludes:

Documents regarding the Company's fiscal and financial operations.
The initial release of Purchased-Part Specifications.
Engineering documents not yet released to production.
Human Resource documents not involving personnel training.
ISO documents and data (See ISO Document and Data Control Procedure)

3.0 RESPONSIBILITY
3.1 The responsibility for the maintenance and implementation of this procedure lies with
the
Document Control Coordinator. The DCC is the custodian of every original ECN
package.

4.0 DEFINITIONS (and abbreviations)

4.1 ECN: An Engineering Change Notice is a notice of the release of, or change to, a
document described in Section 2 above used in the manufacture of any Raditek product.
4.2 ECN Type: The primary company operation to which the ECN is associated.
There are 2 types of ECNs:
 Mechanical/Hardware (Form number DOC-00002-F1)
 Marketing (Form Number DOC-00002-F2)
4.3 ECN Routing: The priority at which the ECN must be processed.
4.4 CCB: The Change Control Board; the group of department-representatives assigned
to
approve or reject ECNs. The CCB is made up of primary and alternate signers.
4.5 Pending ECN: Any unapproved active ECN in the custody of the DCC.
4.6 Approved ECN: Any ECN signed (approved) by the CCB and ready for
implementation in accordance with stated effectivity and material disposition plan.
4.7 Effectivity Date: The date when the ECN's content becomes effective. Unless
otherwise specified in the body of an ECN, the default implementation date is the date of
CCB approval.

5.0 REFERENCE DOCUMENTS

5.1 Document and Data Control Procedure 4.05-P1

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RADITEK INC.

Document Number 4.05 P2 Rev. E

Procedure ECN Processing
5.2 Mechanical /Hardware ECN Form DOC-00002-F1
5.3 Marketing ECN Form DOC-00002-F2
5.4 Software ECN Form DOC-00002-F3
5.5 ECN Approval List Work Instruction 4.05-W1
5.6 Part Numbering and Revision Naming Procedure 4.05-P3
5.7 Document Format and Writing Procedure 4.05-P4
5.8 ISO Document and Data Control Procedure 4.05-P5

6.0 PROCEDURE: The ECN Process:

6.1.1 Initiating: Any employee may initiate an ECN by filling out the appropriate ECN
form.
The ECN form is self-explanatory The initiator must fill in all fields that are indicated as
initiator fields.

6.1.2 Submitting: The ECN is submitted to the DCC

The DCC assigns an ECN number and acknowledges via e-mail within 1 working-day.

6.1.3 Assigning an ECN Number & Document Control Review:

The DCC assigns the next available ECN number (unless ECN number has already been
assigned), logs it into the ECN Status Log, reviews the contents for completeness,
validity
and legibility. An ECN not meeting this standard is returned, with comments, to the
initiator.

6.1.4 Distributing: The DCC creates and distributes a review package for CCB members
in
accordance with the ECN type. Each type has a different CCB approval requirement as
shown in ECN Approval List Work Instruction 4.05-W1

6.1.5 Correcting Discrepancies

6.1.5.1 DCC notifies the initiator about discrepancies which must be resolved before the
ECN can be CCB-approved.
6.1.5.2 The initiator resolves discrepancies and subsequently notifies the DCC of the
resolution.
6.1.5.3 The DCC presents the corrected ECN at the CCB meeting.

6.1.6 CCB and Organizational Approval:

6.1.6.1 An ECN is considered approved after being signed by the CCB members for that
"ECN-type." Each type has a unique signature requirement on the cover sheet.

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RADITEK INC.

Document Number 4.05 P2 Rev. E

Procedure ECN Processing
6.1.6.2 The organization which performs the original review and approval must also
review
and approve changes to Documents and Data.
6.1.6.3 An ECN must contain an Effectively Date and, if applicable, a Material
Disposition.
An ECN lacking these is effective "upon approval" with a material disposition of
"implement immediately."

6.1.7 Incorporating:
6.1.7.1 DCC arranges for the ECN to be for incorporated after CCB approval.
6.1.7.2 Drawings, PPSs and Procedural-type documents need not be incorporated
immediately to be effective or implemented. The approved ECN's content such as red-
lined
markups can be used by Manufacturing or Materials prior to incorporation.
6.1.7.3 Item Masters, Bills of Material, Material Requirements Planning (MRP) and
associated EDM Database entries must be incorporated in accordance with the ECN's
effectivity date.

6.1.8 Releasing: After incorporation, the DCC arranges for the Director of Manufacturing
Operations or Manager of Manufacturing Engineering, or designee, to sign the Revision
Block of the document or procedure, excluding Bills of Material.

6.1.9 Final Distribution and Archiving: The DCC "e-mails" the released ECN to the
affected
Departments as required and archives the ECN.

6.2 ECN Routing: (Reference Section 6.1.4) An ECN's processing-route depends upon
the
routing priority checked on the ECN's cover sheet. An ECN can be routed to the CCB as
routine, urgent or emergency.

Routine: Approval will occur within 7 working days after submission to Document
Control.
Urgent: Approval will occur within 3 working days after submission to Document
Control.
Emergency: Approval will occur within 8 work-hours after submission to Document
Control. An Emergency ECN requires the signature of the VP of Engineering prior to
distribution for CCB review.

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RADITEK INC.

Document Number 4.05 P2 Rev. E

Procedure ECN Processing
6.3 ECN Status

6.3.1 The DCC will assign the following Status to ECNs as they are processed:
Pending, to those newly submitted to Document Control and in-process.
Approved, to those signed-off by the CCB, but not yet incorporated.
On Hold to those not CCB approved and awaiting resolution.
Rejected to those rejected by the CCB.
Incorporated to those approved and fully incorporated

6.4 Synopsis of ECN "rules."

A Purchased Part Specification (PPS) does not require an ECN for initial release.
An ECN is required to change a released PPS.
Incomplete ECN packages will be returned to the initiator for correction prior to
further processing by Document Control.
An Emergency ECN requires the signature of the VP of Engineering.
An ECN must contain an affectivity date and, if applicable, a Material Disposition. An
ECN lacking these, is considered to be effective "upon approval" with a material
disposition of "implement immediately."
The affectivity and subsequent implementation of an ECN may be carried out prior to
incorporating drawings by using red-lined markups.
Bills of Material, Item Masters and MRP data and associated EDM Database entries
must be incorporated in accordance with the affectivity date.

7.0 Appendix: N/A

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