By Alan P. Schwartz
This isn't meant to be double talk. But the question is causing a great deal of confusion for the medical device manufacturing industry.
During a recent FDA inspection, one in which I participated, the FDA investigator raised some interesting points concerning the company's change control of design changes. This area of concern was also raised during a recent inspection of a medical device manufacturer in New Jersey as indicated by the FDA Warning Letter issued to them.
What Does the FDA Require?
The Quality System Requirements (QSR) mandates that you have design controls including control of design changes. The QSR states in section 820.30(i) Design Changes:
"Each manufacturer shall establish and maintain procedures for the identification, documentation, validation orwhere appropriateverification, review, and approval of design changes before their implementation."
This section has been interpreted to be used for the control of the design of the device in order to ensure that specified design requirements are met prior to release for production. The changes to the design requirements would have to be controlled under this design change procedure. Does this design control change procedure apply to devices that have already been transferred to production or only to devices involved in the pre-production stage? This has been a real 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 found in the device master record.
In a recent FDA Warning Letter issued April 3, 2000, to a firm in New Jersey, there was one observation that stated:
"Your firm failed to establish and maintain procedures for the identification, documentation, validation orwhere appropriateverification, 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 in several of your [products] was not verified and/or validated."
From this observation alone, there could be some confusion as to whether this involved a device still in pre-production design control or one that was in production and under device master record control. In fact, this observation was made concerning a change to a device that was already in production.
What's Your Responsibility?
So, what is the responsibility of a company when it makes changes to a device once it has been transferred out of design control into production?
First of all, any change to a devicewhether it is just the changing of a component or a printcould 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 in the good old days when there was only the GMPs (Good Manufacturing Practices) to worry about, 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 reach into a company's engineering department and their design control procedures.
With the implementation of the QSR, 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 orwhere appropriateverification, review and approval of design changes before their implementation. This even involves those changes to a device after that 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(s).
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 was not required, the reasons why should be indicated in the comment section of the form. We have found this to be a very effective means of controlling changes and documenting your decision as to whether or not a change should be put through the design control procedures prior to approval and implementation.
So be aware of the following:
- All changes to a device are, in fact, considered design changes.
- Your quality system should require that all device changes be considered for design control review prior to approval and implementation. Specifically, is validation and verification necessary for controlling the change?
- Not all changes require design control procedures prior to approval and implementation.
- If you decide not to use design control for a change, the reason for this decision must be documented.
Alan P. Schwartz is senior partner of mdi Consultants, Inc., a management consulting firm that helps medical product manufacturers meet FDA requirements. Since 1978, mdi has provided such services as 510(k) submissions, GMP compliance, FDA strategic planning, ISO assistance, as well as market evaluations and strategic partnering. With more than 28 years in the device industry, Schwartz has authored many articles and been a guest speaker both nationally and internationally. He can be reached at firstname.lastname@example.org or through his website at http://www.mdiconsultants.com. Or visit the firm's storefront on Medical Design Online.