INSIGHT REPORT
Vol 3  #5 
May - June 2000

INSIGHT REPORT

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When is a Change to a Device not a Design Change? 
     or 
Do all Design Changes require Design Control?

 

This is not double talk but it is causing a great deal of confusion to the medical device manufacturing community.

During a recent FDA inspection, one in which we participated, the FDA investigator raised some interesting points concerning change control of design changes. This area of concern was also raised during the review of an FDA Warning Letter issued to another medical device firm as a result of an inspection.

The Quality System Requirements (QSR) requires that you have Design Controls including control of design changes. The QSR states in section 820.30(i) Design Changes,

"Each manufacture shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation."

Now this section is in section 820.30 Design Controls and it has been interpreted to imply that this section is to be used for the control of the design of the device in order to ensure that specified design requirements are met.

The changes to the design requirements would have to be controlled under the Design Change procedure. Does this Design Control Change procedure apply to devices that have already been transferred to production or to devices involved in the Design Control Stages? This has been a "bone of contention" during FDA inspections and a cause of confusion for many medical device manufacturers.

The QSR also has a requirement for Document Changes, Section 820.40(b). This section states:

"Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Changes 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."

Now, most manufacturers have accepted this procedure to control changes to any approved document, which would include the records in the Device Master Record.

In a recent Warning Letter issued April 3, 2000, to a firm in NJ, there was one observation that stated:

"Your firm failed to establish and maintain procedures for the identification, documentation, validation or where appropriate, verification, review and approval of design changes before their implementation, as required by 21CFR 820.30(j). Specifically, the investigator noted that changes to your (purged from the report) used is several of your power chairs, was not verified and/or validated."

From this observation, there could be some confusion as to whether this was a device still in design control or one that was in production and under device master record via design transfer.

In fact this observation was made concerning a change to a device in production and under device master record control and not in the design control phase.

So, what is the responsibility of a company as it relates to the changes of the device once it has been transferred out of design control into production?

First of all, change to a device, whether it is just the changing of a component or a print could be construed as a design change. Do all design changes require design control? This is obviously a BIG NO.

Prior to the implementation of the QSR, or the good old times of the GMPs (Good Manufacturing Practices) the FDA required that any change to a device required that you qualify the change. This was meant to assure that you actually tested all changes to assure that the change actually worked and did not affect the device's specifications. As a matter of fact this was one way that the FDA was able to get to review your engineering department and design control.

So, now the FDA has put into words what was expected by policy in the past. A company must now maintain procedures for the identification, documentation, validation or where appropriate, verification, review and approval of design changes before their implementation. This involves changes to a device once the device has been transferred to production.

As was previously mentioned, not all changes require design control. But, if you decide that a specific change does not require design control, i.e. verification and/or validation, then you must document this and indicate why it was not necessary to carry out these tests prior to approving and implementing the change.

This should be made part of your change control procedure. One way you could handle this would be to add a check-off and comment area on your change form. This would include a statement as to whether the pending change required design control, and, if design control is not required, a comment section where to record the reason(s) why. We have found this to be a very effective means of controlling changes and determining if the change should be put through design control procedures prior to approval.

So be aware: 

1. That all changes to a device are in fact considered DESIGN changes. 
2. That your Quality System should require that all device changes be considered for design control review prior to approval and implementation. 
3. That not all changes would require design control procedures prior to approval and implementation. 
4. JUST BE SURE IF YOU DECIDE NOT TO USE DESIGN CONTROL FOR A CHANGE THAT YOU DOCUMENT WHY.

Next Month’s Insight Report –

         The next Insight Report Vol. 3 #5 

• Warning Letter Review

If you have any comments on these INSIGHTS we hope that you let us hear them. If you have any of your own INSIGHTS that you feel would be of value to other companies, we would be pleased to hear from you and to discuss them with you and if you allow, we would even put them up on this site for others to learn from.
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