Medical Devices

9. Document and Change Control

INTRODUCTION
CHANGE CONTROL PROCEDURE
     Identification
     Effective Date
     Responsibility
     Revision Level
     Validation
     Communication
     Updating Documentation
     Documentation Distribution
     Remedial Actions
     Regulatory Submissions
     Business Factors
QUALITY ASSURANCE REVIEW
CHANGES UNDER PREMARKET NOTIFICATION
     Regulatory Background
     Premarket Notification Decisions
     Quality System Control Always Required
EXHIBITS
     Engineering Change Policy/Procedure
     Change Control Forms

INTRODUCTION

There is no easy way to properly control changes to devices, processes, device master records, etc. Change control is a complex process. Failure to have an adequate change control system can cause equally "complex" results. Inadequate change control exposes a company to product liability actions, results in product recalls, causes internal confusion, and is a serious violation of the Quality System (QS) regulation.

Change control activities and procedures apply to: design; components, including software; labeling and packaging; device manufacturing processes; production equipment; manufacturing materials; and all associated documentation such as quality system procedures, standard operating procedures, quality acceptance procedures and data forms, and product-specific documentation. Change control should also be applied to any production aids such as labeled photographs and models or samples of assemblies and finished devices.

The device master record (DMR) is a compilation of records containing the procedures and specifications for a finished device [820.3(j)]. This record contains the manufacturer's documentation for the device specifications and all other documentation required to procure components and produce, label, test, package, install, and service a finished device. Manufacturers are to prepare, control changes to, and maintain a device master record using the document controls procedures outlined in 820.30 and 820.40.

CHANGE CONTROL PROCEDURE

Changes to DMR documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval unless there is a specific designation that states otherwise. These approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include:

a description of the change,
identification of the affected documents,
the signature of the approving individual(s),
the approval date, and
when the change becomes effective [820.40(b)].

For the medium to large company, a change control procedure is one of a family of standard operating procedures (SOP's) usedto produce and control documentation or control activities that result in documentation. The sample engineering change policy/procedure exhibited at the end of this chapter lists a group of six such procedures. However, this chapter concentrates on only one of these -- the change control procedure -- because of the specific requirements for change control in the QS regulation. It is a traditional and current practice for change control procedures to include change control forms. Some manufacturers also use change request forms for suggested changes.

The written change control procedure should describe the company-approved procedures to be followed from the time parts of the device master record are first released for production through examination of a change in relation to other appropriate documents, activities, and implementation. The company procedure should have an appropriate degree of flexibility integrated into it. That is, all changes do not need the same degree of evaluation and approval. Consider manufacturers such as repackers/relabelers that may have to make simple changes such as the size of a container or arrangement of the items in a kit. Also, production runs for some kits may last only a few hours. Obviously, these manufacturers should develop and use a change control procedure that allows rapid changes, approvals, and implementation. The QS regulation is a flexible regulation which allows manufacturers to develop and use procedures that meet their specific needs.

The important point to consider is that all changes are made according to the approved company policy and procedure. A trap that is easy to wander into is the situation where a company, knowingly or unknowingly, allows research and development personnel or other appropriate technical personnel to make changes to a device that is already in production or make changes to an ongoing process without following the approved procedure. Such changes generally do not receive the necessary evaluation and review and, therefore, they may and in many instances have resulted in hazardous or ineffective devices. Making uncontrolled changes is a violation of several sections of the QS regulation, including sections 820.30, 820.40, 820.70, 820.75, and 820.181. Also companies making uncontrolled changes are not operating in a state-of-control. It bears repeating: all changes Should be made according to the approved company policy and procedure.

A change control procedure may be long when a large number of activities are covered. However, a very small manufacturer may have only a few activities. For very small manufacturers, the following are some examples of how to word simple procedures for changing and approving the device master record:

Draw a line through but do not black out the old information.

Ink in the new information.

Date and sign at the change or place a mark at the change which refers the user to the date and signature.

Ascertain that the modified documents are placed into use and the old documents are removed from production.

Ascertain that in-process and old finished devices are reprocessed or discarded.

Record the effective date for these procedures.

The above procedure obviously depends on the devoted attention and knowledge of the person responsible for the change. It is obvious that for a large manufacturer or for complex operations, the person responsible for the change would not or could not "pass the word" to everyone that has a need to know. Hence, the need for written procedures. Small manufacturers, with short communication lines, usually need a less extensive procedure than a large manufacturer; however, the use of a change control form, as described below, by small manufacturers is highly recommended. As the manufacturer grows, all procedures, particularly the change control procedure, should be analyzed and modified to meet current needs. Such a review should be part of the quality system audit.

Change control records for documents should cover:

identification of the entity being changed,
a description of the change,
identification of the affected documents,
signature of the approving individual(s),
the approval date, and
when the change becomes effective.

These elements of a typical change control system are explained below. These controls extend to installation and service when a manufacturer is performing, or contracting these activities.

Identification

The written procedure should cover the identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material and any other related item or document. The change control form should have blanks for recording this data and other data discussed below.

Effective Date

The procedure shall cover the effective date of the change which is usually a completion date, or an action to be performed when a specific event occurs, such as "implement the change when the new mixer is installed, validated, and operational." The blank on the change control form for recording the effective date should not be left empty.

Responsibility

The change control procedure should state which department or designee is responsible for each function to be performed. One of these is the issuance, use, and control of blank and completed change control forms. Another is the extra level of management oversight during the phase-in of a change. (Also see Document Distribution below.)

Revision Level

The way the revision level is to be incremented and which code should be used need to be covered by the change procedure for: components including software, assemblies, and devices; and associated documentation such as labeling, process procedures, and assembly drawings. It is common practice to use numerical revision levels during pilot production and letters during full scale production.

Validation

Each changed device, accessory, labeling, packaging, and process should be thoroughly verified and/or validated by the appropriate department. Then the test results and all information related to the change should be reviewed by the change control board or other designated review group. This procedure is the same as needed for designing and introducing a new product or process into production and is detailed in section 820.30, Design Controls. Changes that only modify documents and do not change any design aspect of a device or process are performed according to 820.40 Document Controls. The change control procedure should state the details of the evaluation and review process or, as appropriate, refer to the company control procedures. The change control procedure should define the responsibilities of the various departments and members of the review board.

Communication

The change procedure should cover the communication of changes to all affected parties such as production, purchasing, contractors, suppliers, etc. As appropriate, activities that apply to internal operations are also applicable to suppliers. Examples are employee training, rework, or disposition of in-process assemblies, use of revised drawings and/or procedures, and disposition of old documents.

Updating Documentation

The change procedure should cover updating of primary and secondary documentation such as instruction manuals. Usually there are no problems with updating or revising primary documentation -- in fact, that is a major reason the given change order is being processed. In contrast, it is rather easy to forget that related secondary documents such as component drawings, instruction manuals or packaging require revision if affected by a given change. The use of a good change control form can alleviate this problem.

Documentation Distribution

Revised documentation should be distributed to persons responsible for the operations affected by the change and old documents removed and filed or discarded, as appropriate. After a document has been approved, these documents shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. This means current documentation shall be accessible to company employees [820.40(a)]. Supervisors should be vigilant in overseeing the flow and use of documentation, especially if a change is being phased in, because both the old and revised documentation may exist in a given department during the transition period.

Remedial Actions

Certain changes may affect installation or servicing, or require remedial action in the field or rework of warehouse stock. Changes of this nature should be addressed in the change control procedure. The change control procedure should outline the documentation and activities required for changes involving installation, servicing, or field remedial actions or rework of warehouse stock. (Note that field remedial actions may be classified as recalls depending on the nature of the change. Generally, rework of warehouse stock which is under a manufacturer's control is not classified as a recall.)

Regulatory Submissions

Modifications to devices or manufacturing processes should be made and covered under the quality system change control procedure as described herein. Such changes may also require a premarket notification [807.87(g)] or premarket approval (PMA) supplement (814.20) depending on the classification of the device. The change order or control form is a convenient document for reminding employees that regulatory submissions should be considered when making a change.

Business Factors

In order for the change procedure to be complete, it should also cover other factors such as financial impact, modification of sales literature, update of products in commercial distribution, etc.

QUALITY ASSURANCE REVIEW

Identifying the need for change; making, evaluating, and reviewing the change in the product or process; and revising and distributing the documentation is about half of the change control process--the change also needs to be correctly implemented. Quality assurance and other designated personnel should make certain that the change is fully implemented during routine production, as shown by data and activities that meet GMP requirements for:

review of production records [820.80(d)(2)];

acceptance of components, labels, materials, etc. [820.80];

assuring that quality assurance checks are appropriate and adequate for their purpose and are performed correctly [820.30(d)], [820.181(c)] and [820.80(d)(1)];

finished device evaluation [820.80(d)];

collection of device history record data to demonstrate that the device is manufactured in accordance with the updated device master record [820.184]; and

making certain that only accepted product is distributed, used, or installed [820.80(d) and 820.86].

The change procedure should cover these activities and specify that they are accomplished before the first lot of the changed devices is released for distribution. After the change is implemented, resulting components, in-process items and finished devices should meet the new specifications established in the revised DMR as shown by the data in the Device History Record. This agreement, of course, is assured by the change control procedure as well as the remainder of a manufacturer's quality system.

CHANGES UNDER PREMARKET NOTIFICATION

When making changes to devices and associated manufacturing processes for substantially equivalent devices, manufacturers should consider both Subpart E of Part 807, and Part 820 of Title 21, Code of Federal Regulations, which address Premarket Notification Procedures and Good Manufacturing Practices for Medical Devices, respectively. By considering these simultaneously, labor costs can be reduced and compliance enhanced.

Regulatory Background

Under the Act, the burden is on the manufacturer to determine whether a premarket notification should be submitted for a change or modification in a device. It is not intended that the owner should submit a premarket notification for every change in design, material, chemical composition, energy source, or manufacturing process. Rather it is the manufacturer's responsibility to determine if a proposed change could significantly affect safety or effectiveness. If this change will affect safety or effectiveness, another Premarket Notification submission [510(k)] shall be submitted to FDA. (Please see Premarket Notification 510(k): Regulatory Requirements for Medical Devices, FDA 95-4158 and Deciding When to Submit 510(k) for a Change to an Existing Device.)

Changes in manufacturing processes, labels, packaging, device master record, design, etc., of a device are also subject to GMP requirements in sections 820.30, 820.40, 820..70, 820.75, 820.90, and 820.181. Compliance of manufacturers with these change-control requirements is checked during comprehensive inspections by FDA investigators. Manufacturers may consider their degree of compliance with the QS regulation as one factor, but not the sole factor, when making decisions about premarket notification submissions for modified devices or processes.

Premarket Notification Decisions

Premarket notification submissions are required for changes that could significantly affect safety or effectiveness and for new or modified intended uses. Additional submissions are not required for marketing or convenience changes where safety or effectiveness could not be significantly affected. Management should decide whether or not a change meets the threshold requirements for submitting a new premarket notification. While waiting for an FDA review of the submission, a manufacturer may continue to distribute the unchanged device for its original intended use.

Some manufacturers with highly qualified personnel and substantial experience may feel confident in performing various technical operations and analyzing results to determine that a particular change in a device, component, or manufacturing process will not significantly affect safety or effectiveness of the device. After technical activities are completed and documented, the results should be reviewed by a design-review panel, change control board, or equivalent group. Reviewing changes should include design verification/validation, change control procedures, equipment qualification, equipment calibration, process validation, personnel training, and routine manufacturing procedures. If it is determined that the change(s) to a previously FDA cleared device could not significantly affect safety or effectiveness of the device, then the intent of the regulation has been addressed and there is no need to submit an additional premarket notification. If this thorough review of proposed changes indicates that a change will significantly affect safety and effectiveness, either positively or negatively then another premarket notification shall be submitted.

Quality System Control Always Required

Section 807.87(g) requires that a premarket notification submission "include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device." Regardless of whether a change is submitted under the 510(k) process, the change should be evaluated under the QS regulation and the associated data filed for an appropriate period of time (820.180) because demonstration of process effectiveness and use of adequate quality assurance acceptance criteria for finished device release are GMP requirements. Change control is also necessary to assure that a modified device or process results in a device that meets company quality claims. Otherwise, the device is adulterated according to Section 501(c) of the FD&C Act.

The above information applies to changes contemplated for devices and associated processes that are subject to premarket notification requirements. If proposed device and process changes are for devices subject to Investigational Device Exemption (IDE) requirements or Premarket Approval (PMA) requirements, then FDA approval should be obtained, in advance, by submitting a supplemental IDE or PMA.

EXHIBITS

An example of a detailed change control procedure and several change control forms are described below and exhibited.

Engineering Change Policy/Procedure

This example of a change control procedure is typical of those used by many manufacturers of electromechanical products. It includes all of the elements described in this chapter and may be used as a guide in developing a change control procedure for medical devices.

Change Control Forms

To aid in the daily use of a change control system, manufacturers often use two forms in conjunction with the change control procedure. Examples of these forms are printed after the sample change control policy/procedures. The first form is called a request for engineering action (REA) or a similar title -- it is a "technical suggestion box." The use of this form encourages all personnel to be involved in product and process improvement, allows management to assign priorities to various tasks, and tends to prevent lack of action. The second form is called an engineering change order (ECO), engineering change notice (ECN), or a similar title. For most manufacturers, the use of ECO paper or computer forms is essential for the implementation and control of all the many elements in a change control system. A log of changes is usually maintained for fast reference to old ECO's and for controlling the issuance of sequential numbers for new ECO's. Also, if used, the completed REA and ECO forms need to be filed as required by the QS regulation in 820.180.

One of the example forms, Engineering Change Package (ECP), is simply an ECO cover sheet for a group of ECO's. An example of a filled-in group change is included. It includes the completed ECP cover sheet and two completed ECO forms. The other three completed ECO forms noted on the example ECP are not reprinted.

The contents of any forms selected for use by a manufacturer and how to use them should be discussed with all affected departments. Manufacturers may use, if appropriate, the example forms as exhibited or modify them to meet their specific needs. In either case, after using an ECO procedure and forms for a few changes to products, processes, and associated documentation, improvements to the form or procedure will become obvious if needed to meet the needs of a specific operation of a company.

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COMPANY LOGO

No: __________

Rev: ____________

DATE: ___________

Sheet 1 of 8

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SUBJECT: ENGINEERING CHANGE POLICY/PROCEDURE APPROVED:

____________________________,

President

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1.0 PURPOSE: The intent of this policy is to assure that our products are, and remain, what we intended in our product specifications; are safe, efficacious and reliable; meet the needs of the marketplace; and are cost effective to manufacture and test on a continuing basis.

2.0 SCOPE: This policy establishes the procedures to be followed for engineering changes to devices or manufacturing processes.

3.0 APPLICABILITY: The responsibilities and procedures established by this policy shall apply to all released documents. The policy becomes effective immediately upon approval by the President.

4.0 APPLICABLE DOCUMENTS: The latest revision of the following documents form a part of this policy to the extent specified herein:

No. xxx Document Control Policy/Procedure

No. xxx Document Part Number Policy/Procedure

No. xxx Interchangeability/Compatibility Policy/Procedure

No. xxx Obsolescence Policy/Procedure

No. xxx Change Request Policy/Procedure

No. xxx Design Review Policy/Procedure

(Copies of these procedures and the ECO form discussed below are not included in this Manual. The REA form is reprinted at the end of this procedure.)

5.0 DEFINITIONS

5.1 Engineering Change Board: Each Engineering Change Board Member will represent a major area of activity. The Board will be under the direction of a moderator appointed by the President. The Change Board will meet to review the technical content of all proposed changes to released documentation for accuracy and impact on safety, efficacy, reliability, product cost, parts and finished goods inventory, work-in-process, instruction and service manuals, data sheets, test procedures, product specifications, compatibility with existing products, and other factors listed in ________section of Design Review Procedure No. _____________.

Sheet 2 of 8

5.2 Change Request: A request for engineering action (REA) may start the change activities. The next stage is the completion of an engineering change request. An engineering change request (ECR) is a completed engineering change order form filled out as described in this policy but unsigned by the Change Board (i.e., is, it is an unsigned ECO form -- there is no ECR form in our company). To merit consideration by the Board, the change request must be complete. Unless the change is so simple that it can be readily understood from the Engineering Change "Request" form, the formmustbe accompanied by a reproducible copy of the last released revision of each sheet of documentation from the device master record that will be affected by the ECR if it is accepted. The reproducible copy must be marked with all proposed changes.

5.3 Engineering Change Order (ECO): An ECO is an ECR (that is, the completed ECO form and associated documents) which has been approved by the Engineering Change Board. An ECO must present a statement of the problem, a solution, updated documentation, an effective date, and a statement that the device and proposed changes meet regulatory requirements.

5.4 Regulatory Compliance: The review by the Change Board includes an analysis of the change with respect to regulatory requirements. For example, the following questions should be answered.

1. Is the change significant enough to require a 510(k) submission?

2. Is there a major change in the intended use? [Requires a 510(k).]

3. Does the change affect our quality system? (A new use such as infusion pumping by an existing precision metering pump means additional GMP requirements may apply.)

4. Do we need to change the labeling in order not to be misbranded?

5.5 Disposition: This action statement defines the updating or disposition of nonconforming materials, components, labeling, software, in-process assemblies, and finished devices at all applicable locations such as suppliers, stockroom, production lines, final test area, finished goods storage, and in field service.

5.6 Effective Date: The effective date will be expressed in terms of shipment date. That is, every change shall be applicable to all units shipped after a specific date. If shipment does not occur by the date specified, an amendment must be issued. The amendment will be presented to the Change Board and upon approval, the ECO cover sheet will be reissued. Quality Assurance has responsibility for verifying that the effective date is met as specified and for maintaining records showing the actual effective date of each change. If a change is not effective by the date specified, Quality Assurance shall be responsible for requesting an amendment to change the effective date.

5.7 Cost: At the Change Board meeting, each department shall be prepared to give the cost impact on its area for implementing each change order. Finance shall assure that all financial implications are considered because the cost analysis must include engineering time, manufacturing time and material, and field service material and labor. The following cost data is to be available at the meeting.

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1. Amount of increase or decrease in per unit unburdened material and labor cost. This cost change is not to include extraordinary costs of rework and scrap which are incurred only when the change is first phased in.

2. Total unburdened cost of material to be scrapped in each location indicated on the ECO form.

3. Total unburdened rework cost for all items requiring rework.

4. Total unburdened engineering manpower and material required to design, test and document the change.

5. Where rework or replacement of units in the field is involved, Field Service must indicate the proportion of costs to be charged to warranty expense.

5.8 Amendment: An amendment may be issued only to change the effective date or correct drafting errors in implementing the change order. Any Board Member may request that an amendment be issued.

5.9 Board Member: An Engineering Change Board Member shall be a person appointed by the area manager to represent a particular functional area. A Board Member may represent more than one functional area. For changes to a process, or design of a device, labeling, or packaging, board members must at least include a design review to meet the following GMP requirements:

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.

The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as any specialists needed.

The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file [820.30(e)].

5.10 Alternate: Each functional area shall also designate an Alternate who shall be available to attend Change Board meetings in the event that the Board Member is not available. Each functional area is to notify the Change Board Moderator of the names of its Board Member and Alternate.

6.0 RESPONSIBILITIES

6.1 Engineering Change Board Moderator: The Engineering Change Board will meet at the discretion of the Moderator. The Engineering Change Board Moderator is responsible for the conduct of the Change Board meetings. This person is appointed by the President for an indefinite term. At least one full working day before each meeting of the Change Board, the Board Moderator shall distribute to all Board Members a copy of all ECR's to be discussed at the next meeting of the Board.

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6.2 Engineering Change Board Members: Engineering Change Board Members shall be responsible for the functional areas they represent in all matters relating to engineering changes and shall be empowered to act on behalf of their areas in Board actions. The Board Members or Alternates shall come to each meeting thoroughly prepared to discuss each Engineering Change Request (ECR) to be discussed. Specific Board Member responsibilities are listed below.

Product Management - Product Management shall determine the effect of changes on marketability, field information, catalogs, price lists, data sheets, and gross profit margin. Product Management must verify the suitability of each design (not documentation only) change in the international as well as the domestic marketplace.

Field Service - Field Service has responsibility for determining the: time required to implement the change in the field; availability of components and assemblies for retrofit; impact of the change on service manuals; and adjustments to service stock. Field Service will make the changes in the areas under their jurisdiction and pass other defined tasks to appropriate departments.

Quality Assurance - Based on verification data, analysis and design reviews, Quality Assurance and manufacturing engineering shall be aware of the effect of all changes on test requirements and on overall quality of our products and assure that product specifications are met. Quality Assurance shall assure that there is compliance with customer, corporate and regulatory agency requirements.

Manufacturing - Manufacturing shall determine component and raw material availability, break-in point, effect on material-on-order, material-in-process and material-in-stock. Manufacturing engineering shall assure that manufacturing and test procedures are adequate. Manufacturing shall determine total cost to the Manufacturing Department of implementing each change.

Engineering - Engineering is responsible for making certain that the change is technically feasible and complies with appropriate company and customer specifications and with accepted standards. Every major change must be fully analyzed and tested (verified) and the results documented by Engineering before it becomes a change order. Any Change Board Member may request that Engineering furnish evidence of technical viability of a change. If the Board so decides, a change may be tried in Manufacturing on a limited pilot production basis before final approval and implementation in full-scale production. None of the trial units may be shipped until the change has been verified; validated, if appropriate; subject to design review; and received final approval. If, as the result of such trial production, the change is altered or modified before final approval, all of the trial units must be changed to the final form before shipment.

Engineering shall supply QA and Manufacturing Engineering with copies of verification protocols, if any, to be used to update production test methods. The updated production documents are part of the change.

Finance - Finance shall make certain that all financial aspects have been considered.

6.3 Engineering Documentation Section (Engineering Services): Engineering Documentation Section shall have overall responsibility for coordinating, scheduling, and executing documentation changes.

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7.0 PROCEDURE: The procedure followed for a given change depends upon whether the change is only to documentation or is a change that affects design, the manufacturing processes or just documentation.

7.1 Procedure for Design and Process Changes

1. A request for engineering action (REA) is completed and forwarded to the Manager of Engineering Services. (The REA form is reprinted at the end of this procedure.)

2. A number is assigned and appropriate audit controls are established. Engineering Services then sends a copy of the REA to the cognizant device or process design section for recommended solutions, evaluation of impact on specifications, and a recommended effective date. As appropriate, the changes must be supported by device verification data and/or process evaluation data or validation data. The REA is then forwarded to the Engineering Documentation Section.

3. Upon evaluation for adequacy of data, where-used considerations for the items being changed are made. Engineering Services makes certain that the latest revision of all affected documentation is included. If not already done, an "ECR" (unsigned ECO) form is completed at this stage.

4. Sepias (or separate computer versions in a computerized system) are made of all affected documents. The ECR number and proposed changes are marked on the sepias. These sepias are included as part of the ECR. The only exception from this procedure is where the change is basically self-explanatory, i.e., where all necessary information can be discerned from the section on the ECR form indicating "change from" and "change to."

5. The Engineering Documentation Section will then duplicate and distribute copies of the ECR to each Change Board Member. Upon receipt of the ECR, each Member shall review the proposed change and determine the impact on their area.

6. The Change Board Moderator then calls a Change Board Meeting.

7. All aspects of the change request are reviewed at the meeting including the following: Is the ECR presented so that anyone may understand the problem and the solution? Does the verification data show that the device meets the device product specification? Does the device continue to meet the intended use and the needs of the user/patient? Has all documentation including manuals and data sheets been updated?

The Board will then establish a reasonable effective date. Finance will make certain that all costs of this change have been considered. After agreeing upon an effective date, each Board Member signs the change request. Each signature implies concurrence with the method of solution, effective date, and costs. If the Board Members are unable to reach a unanimous decision, the issue is submitted to the President for resolution.

Sheet 6 of 8

After all Board Members in attendance have signed, the ECR becomes an engineering change order (ECO). Copies of the cover sheet may be issued by Technical Services upon request of the Board Members if the effective date is very near and the Change Board has not modified the ECR before approval. This action permits Manufacturing to use the previously distributed marked-up sepias or "from-to" information on the ECR as operating documentation until copies of the updated original documents are available for distribution.

It is the responsibility of Manufacturing to indicate the earliest permissible effective date in all areas, i.e., supplier, stockroom, raw material, and work-in-process. It is the responsibility of Field Service to indicate an effective date for any field activities.

8. The change order is then sent back to Technical Services where copies are made for the Board Members, who requested them. Upon completion of this task, the master documentation is withdrawn from the print file, updated to the new revision, and copies are distributed and obsolete documents are collected. During the updating process, a copy of the marked-up sepia (if any) replaces the master in the print file.

9. After all documents are updated, the change order is filed permanently in the design history file for the device. The verification protocol and data and design review documents and minutes are also placed in the design history file.

7.2 Procedure for Minor Changes and Changes in Documentation Only.

This procedure is the same as that for design changes except that the second and third steps read as follows:

2. A number is assigned and appropriate audit controls are established. Upon evaluation for adequacy of data, where-used considerations are made. Technical Services assures that all affected documentation is included and that it is the latest revision.

3. Technical Services then sends a copy of the ECR to the Design Section for evaluation of the effect of the changes on the device and for recommendations on the effective date to be suggested to the Change Board. The ECR is then returned to Technical Services.

8.0 ENGINEERING CHANGE ORDER FORM (ECO): A definition of the various items on the form and instructions on completing each item follows.

1. Status: At the top of the form are the words "Engineering Change" followed by two words, REQUEST and ORDER. When the mark appears in the request area or the form is not signed by the Board Moderator, it shall be considered a request or preliminary copy -- not an action copy. The change order is an action copy which must bear the signature of all Board Members or their Alternates. (The Moderator is empowered to sign for any function not represented at a meeting.)

Amendments: Amendments shall be designated by an alpha suffix, e.g., A, B, C, etc.

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3. Originator: The individual who initiated the REA that resulted in the ECR or ECO.

4. Interchangeability/Compatibility: This area is made up of two blocks. First block is "Yes", second block is "No". Interchangeability/Compatibility is expected to be checked off as "Yes" when it affects form, fit, or function of any numbered part. (The design, design verification and design review must always consider interchangeability and compatibility.)

5. Change Complete Block: The drafting supervisor shall sign this block when the documentation is updated.

6. Prerequisite: Is there another ECO or new Product Release Notice which must be effective before this change can be implemented? If so, what are the numbers?

7. Reference: In this block will be listed any references such as REA's, etc.

8. Device Affected: This block is used to indicate which device(s) or device line is affected by this particular change notice.

9. Description of the Problem: The description must be presented so it can be fully understood by the technical personnel involved.

10. Solution: The solution is what has to be done to correct the problem. It must be explained in terms that can be fully understood by our technical staff

11. Item Number: A sequential number beginning with 1.

12. Size: The size of the sheets of the drawing or procedure.

13. Revision: From what revision level the document is leaving and to what revision level it will go.

14. Description: This section must contain a general description of the drawing, not necessarily its title.

15. Where Used: To which device(s) or processes do the changes apply? This information is especially important if a component is used on several devices.

16. Disposition:

1. Engineering Cost: List engineering cost of design and documentation change.

2. Supplier: What needs to be done to update in-process assemblies at a supplier, i.e., rework, use as is, or scrap?

Sheet 8 of 8

3. Stock Room: What should be done with non-conforming purchased components in our stock room? By what date should the above action be complete?

4. Work-in-Process: What do we wish to do with the material on the floor?

5. Finished Goods: What do we do with the material in finished goods?

6. Field Service: What should be done to devices in the field?

7. Cost: Each department is responsible for reporting the cost of the change with respect to its area.

17. Effective Date: Each change shall be applicable to all units shipped after a particular date where the date is relatively unimportant because the change is a minor documentation change. In all other changes, an effective date must be assigned by the Board. If it is important to a particular functional area that a change be implemented by a date or not sooner than a date, it is the responsibility of the appropriate Board Member to assure that an acceptable effective date is designated.

The change notice is broken into Parts 1 and 2. Part 1 shows how to update the documentation. Part 2 is the special rework instructions required by Manufacturing or Field Service Operations on how to update a component or assembly that does not conform to the new revision.

(Note: The specific ECO form for this procedure is not included in this manual. However, several ECO forms follow. One of the example forms, Engineering Change Package (ECP), is simply an ECO cover sheet for a group of ECO's. An example of a filled-in group change is included. It includes the completed ECP cover sheet and two completed ECO forms. The other three completed ECO forms noted on the example ECP are not reprinted.)

REQUEST FOR ENGINEERING ACTION		REA No.
Originator	Dept	Date
Component, subassembly, or device:
Drawing(s)
Problem (in detail)



Solution recommended, if known	Date action required by




Comments


Dept Manager approval		Date
Assigned to	Date forwarded for solution
SOLUTION	Charge No.	Priority




App. By	ECO Number	Date

Notes on back? YES Sheets attached? YES

PROCEDURE

1. Originator: Complete top of this form except for REA number.

2. Obtain your Department Manager's approval.

3. Forward original to Technical Services Manager who will assign the REA number.

Note: One copy will be returned to originator with REA number assigned.

If problem involves safety, effectiveness, or reliability, Technical Services will forward to the QA Manager a copy with the REA number assigned.

4. Technical Services takes appropriate action and also executes an ECO.

5. Technical Services returns a copy to Originator after resolution of problem.

Form No. Rev. App. By Date

COMPANY LOGO

Engineering Change

Order (ECO)

ECO #

Signatures

Date

Approvals

Date

Reason for Change

Originator

Type A

[ ] Improve process [ ] Biocompatibility

[ ] Design improvement

Project Engr.

Type B

[ ] Correct error [ ] Cost reduction

[ ] Customer request

TYPE

Type C

[ ] Labeling or packaging

A[ ] B[ ] C[ ]

[ ] Regulatory

DESCRIPTION OF CHANGE

Action

Code

Drawings

Affected

REVISED

From To

Change action required

codes

Change action required

codes

Purchasing

and

Production

Rework components in stock

Service

and

Repair

For reference only

Rework part in-process

Scrap in-process items

Make new parts

Other

Action

Labeling Change Parts in Field

Rework finished goods

Packaging Notify User of Part

Notify supplier

Employee training

See old parts for spares

510(k) required for Change