Quality Name Plate AS9100 Quality System


QNP AS9100 Main Index


Change Impact Analysis

Change Impact Analysis: OP-836-01 rev A

Effective Date: 4-13-17
Owner Approval by Andrew Adams, Quality Assurance Manager, on 4-12-17
Management Approval by Craig O. Garneau, President, on 4-12-17


Printed copies of this document are for information purposes only and are uncontrolled. Printed copies are not valid after the date of printing. This document was printed on


1. PURPOSE

To describe the process and due diligence performed by Quality Name Plate, Inc. (QNP) used to identify the potential consequences of a change, or to estimate what needs to be modified to accomplish a change.

2. SCOPE

Applicable to QNP’s Tier 1 designated customers only. This procedure provides guidance to customer submitted changes between requirements, design elements, specifications and functional test requirements to determine the scope of an initiating change. 

3. TERMS AND DEFINITIONS

3.1. Originator – A person who creates or initiates

3.2. Document Expert – A person who has comprehensive and authoritative knowledge of or skill in regards to a particular specification, requirement, or manufacturing process.

3.3. Work In Process – An unfinished project that is still being added to or developed

3.4. Store Stock – Inventory

3.5. Lead-Time – The latency between the initiation and execution of a process

3.6. Cost – An amount that has to be paid or spent to buy or obtain something

3.7. Sub-Tier – A supplier in the supply chain

3.8. Special Process – Operation which converts or affects material properties

3.9. Frozen Process – Defined as absolutely no change is allowed to any process unless approved by the end user

3.10. Manufacturing Process – Steps through which raw materials are transformed into a final product

3.11. Procedures – A documented, established or official way of doing something

3.12. Work Instructions – A description of specific tasks and activities within an organization

3.13. Shop Order – QNP’s internal quality plan record. FM-710-01

3.14. Training – The action of teaching a particular skill to a person

4. GENERAL

4.1. The Quality Manager is responsible for implementation, oversight and training related to this document. All QNP employees involved in contract review, engineering, and quality are responsible for complying with the requirements and processes identified in this document.

4.2. Change Impact Analysis is performed when a change occurs in the design of the part or referenced specification. This is typically in response to a problem, a new identified risk, or a customer driven revision/engineering change to a blue print and/or specification.

4.3. The following criteria should be met prior to implementing the actual design change on the part/device:

4.3.1. The part/device is under configuration management.

4.3.2. A proposed change is to be made.

4.3.3. The details of the change are known.

4.3.4. The design (at all levels) is configuration controlled.

4.3.5  Referenced specification revision.

5. Responsible Personnel

5.1. The Customer Service employees or the Originator are/is responsible for reviewing the customer’s purchase order for any changes. This may include but is not limited to the following:

5.1.1. Customer’s drawing/print revisions

5.1.2. Customer email/fax requests

5.1.3. No verbal change requests will be used as acceptable means of communication

5.2. If a change is identified, the Originator will request a change impact analysis by initiating form FM-830-01 and submitting it to the Document Expert (e.g. Engineer / Quality Representative).

5.3. The Document Expert is responsible for evaluating the new/revised document to identify the impact of the change.

5.4. The Document Expert completes Section B of form FM-836-01, identifying any areas potentially impacted by the change. The following will be taken into consideration:

5.4.1. Will the proposed change adversely affect performance requirements, maintainability, or other quality attributes?

5.4.2. How extensive is this change? (Minor, Moderate, Major)

5.4.3. Will the proposed change place unacceptable demands on any resources?

5.4.4. Will the change require any kind of recertification?

5.4.5. Will the change potentially damage the hardware?

5.4.6. Will the proposed change alter any output type or value?

5.4.7. What are possible adverse side effects or risks of making the proposed change?

5.4.8. What are the consequences of not making the change?

5.5. If the impact analysis is complete and shows no undesirable impacts caused by the change; the Document Expert submits form FM-836-01 to the Quality Assurance Manager or their designee for review.

5.5.1. IFF the analysis shows any undesirable impacts from the change, then the Engineering Review Board (ERB) will review the changes and communicate back to the customer.

5.6. The Quality Manager or their designee will approve the changes and submit form FM-836-01 to the Originator as to finalize the form and file it with the customer’s Purchase Order. 

5.7. The Quality Engineer performing the Quality Planning will update the production Shop Order form FM-710-01 with any appropriate changes as applicable. 

6. RELATED DOCUMENTION

6.1. FM-836-01, Change Impact Analysis Form

6.2. FM-710-01, Shop Order

RECORDS/OBJECTIVE EVIDENCE

The retention duration for records referenced in this procedure are available on-line in the FM-423-01 Master Document List with Revision History.
Records are maintained in accordance with OP-424-01 Control of Quality Records.
 


REVISION HISTORY

Revision, approved date, effective date, and a document change summary for this document is located on-line in the FM-423-01 Master Document List with Revision History.