Engineering Change Order System
This sample procedure is based on the use of a database for tracking ECOs. It is also based on having different class of ECOs.
The different classes of ECOs allow simple changes to be made with a minimal of effort and approval while major changes require approval from the executive management. About 80% of ECO should be the basic kind. These ECOs should take less than 30 minutes to fully implement including the drawing change, system database change and documentation of the ECO itself. This will still cost the company about $20 (@$40/hour) to make a change but that is better than most companies.
The purpose of this procedure is to define the requirement for corrective and preventive actions.
This procedure applies to all company personnel who are responsible for planning, development, use, and maintenance of the quality management system (QMS) at ACME, Inc.
4.1 Quality Manual.
4.2 Engineering Change Orders
5. ASSOCIATED DOCUMENTS
All changes to a product or controlled document require an ECO. The ECO form consists of a single page that details the scope of the change, status and approval signature. The scope of the ECO determines the class (I, II, or III), type (standard or temporary), and documentation requirements for the ECO. Documentation shall be attached to the ECO to describe the affect of the change on different areas. See section 3.5 for information about the requirements for each area. An ECO may change any number of documents. The flow chart below shows how the ECO is processed. Products with Agency Approvals have special requirements as seen in the chart.
Engineering change request
An preventive or corrective action request in the form of a ECR can be made at any time using a verbal or email request to the ERC/ECO manager.. This request is then entered in the Quality system database. If the action request is found to be appropriate, The ERC/ECO manager will initiate as ECO. In appropriate request will not generate an ECO. ECR can also be entered directly by anyone with access to the database.
Engineering Change request can com from any source. Every Complaint from the independent customer survey should result in an ECR.
ACME has 3 classes of ECOs. The classes are designed to keep the level of documentation proportion to the affect and cost of the change. The engineering or accounting manager is responsible for setting the class during the pre-approval process.
Class I: Class I ECO have a financial impact of $5000 or greater, effect product in the field and may include a recall. Prior to approval the ECO must include financial justification and impact analysis and timeline for the completion. A product recall is always a Class I change.
Class II: Changes that affects the service organization, inventory or outside organization including approval agency are Class II ECO. Any changes with a financial impact of over $500 is a class II ECO. Products with Safety approvals must be approved by the organization prior to implantation.
Class III: Class III ECO are used for minor changes that do not affect inventory significantly, outside customer or outside agency. They have a financial impact on the company less than $500. The do not affect field service Class III ECO includes pre-production products, accounting functions, clarifications, typo corrections and changes that that do not affect the form, fit, or function of the product or part.
If the ECO affects products in the field to the degree that a recall is required, the ECO must be a Class I. All customers affected by the ECO will be contacted with instructions on how to proceed with the return of the nonconforming product. A Field Recall Execution Plan (FREP) will be developed that includes a master list of all non-conforming units. The master list will be kept until all the customers have been identified, contacted, and their problems resolved. Any outside suppliers or partners will be notified. Any relevant Approval Agencies will be notified during the investigation/engineering stage and they will be distributed a copy of the FREP . The ECO shall not be closed until the recall is complete. The list of non-conforming serial numbers will be kept with the ECO file.
In the event that it is not possible to contract 100% of the customers who have received a recalled product(s), then ACME, Inc will advertise in established journals and trade publication that the product has been recalled. These ads should give information about how customers with a recalled product should address the problem (i.e. call or contact the factory).
3.6 Approval and Distribution
The ECO requires both pre-approvals and approvals before the change is implemented. Pre-approvals happen during the investigation of the ECO and Approvals happen after the change has been developed, tested and documented. Once the solution is documented, the Doc control depart will promote the rapid approval of the ECO. Different signatures are required based on the Class (as seen by the shaded blocks on the ECO form). The ECO may be returned to the ECO Manager if there are any errors or omissions. The Database automatically show which signatures are required base on the ECO class. The following table shows the Signatures and who is allow to sign.
The authority to approve ECOs is listed in the employee training records. The following table list general rules for approval.
After the final approvals, the document control department/engineering manager will complete all doc changes included the central computer system, part specifications, assembly prints, Routings, SOPs, Manuals. GS sheets and any other documents required.
Changes that affect Inventory, WIP, Parts on Order are managed by the production manager. All changes to production software are managed by the production manager.
All changes that affect the service software are the responsibility of the service manager. Changes that affect the field including field recalls are the responsibility by the service manager.
Documenting Changes to Entries in the Manufacturing and Purchasing Systems: Implementer?s Responsibilities
As part of the Implementation, the Implementer of an ECO must document any changes to existing entries in the Baseline System required to complete the ECO as described in this subsection.
BOM Change Implementation:
If a BOM change has been approved, the Implementer must complete the following steps.
a. Complete all corrections on the manufacturing system
b. If necessary make all changes to the Routing.
c. If necessary make all changes to the Components List.
d. Compile the new component list.
All document must be published to the system.
Procedure revision change implementation:
If an ECO effects a procedure, then the ECO manager must check work in process (WIP). If the change effects the current production, then the Work Orders for the current product must be reprinted to reflect the current revision of the procedures. Changes may or may not affect the WIP.
Controlled Drawings and Approved Products
If the ECO is for an intrinsically safe (IS) product, the ECO manager should press the "View controlled drawing" button to confirm that the ECO does effect a controlled document. If the document is listed as controlled, then the change will require a PAR (project authorization request) or prior approval from a certified body before the change can be done. In this case, the ECO should include checks by the appropriate boxes (UL, CSA, etc) and use the distribution list pick the appropriate person to request the PAR. A blank PAR is available on the internet.
Once the ECO is signed for final documentation is complete, doc control of the Engineering manager may distribute copies of the new documents to all affected parties based on section 3.5. Final document will be emailed or mailed to all external parties based on their requirements.
Any new or corrected documents should be managed based on document control procedure