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Design Control Be Not Painful

Has this ever happened to you?  The Class II medical device that your Engineering Department has been working on for the last eighteen months is finally complete (so they say, for the umpteenth time.)  The Regulatory Department dusts off that 510(k) that was prepared several months ago (when the design was supposedly finished the last time.)  And, in the medical device industry version of a triple witching hour, the QA department just finished the annual internal audit of the Engineering Department, with the finding "There was no objective evidence of conformance with the Design Control SOP.  Specifically, although Engineering had been working triple overtime to complete the design of the latest product, there is no design history file, required by 21 CFR 820.30, and the internal SOP."

It doesn't need to be this way.  The Design Control requirements of the Quality System regulation (21 CFR 820.30), ISO 9001, EN46001, and ISO13485 are not a punishment, but intended to ensure that you do two things:  Design the device correctly and design the correct device - the one everyone thought you were designing.   Interestingly enough, it turns out the most straightforward way of doing this, with a reasonable level of supporting documentation, is to just follow the regulations.   Yet, for many companies which composed their design control SOP straight out of the FDA regulation and the standards, it has turned into a torturous thankless task.   And, so, it is rationalized, "our Notified Body audit is not for another 6 months...,"  or "FDA was just in here...we've got plenty of time to do the design history file."

There may be unfortunate outcomes for companies that play these games.  Of course the worst is that something in the design was inadvertantly omitted, not tested properly or completely;  a design defect resulting in only costly re-design if you're are lucky, recall if you're not.  The best is that you broadcast the message to your staff: "This quality system stuff, it's just an act.  We don't need to follow this every day.  We can get away with getting the important stuff done, and save the documentation for a rainy day."   This message is like a narcotic.   Once one department gets it, it propagates throughout the company, leaving all with the same mindset. 

You may say, "Not at our company."  But not so fast.  A review of the FDA Warning Letter database hits by Canon Publications, publishers of magazine MDDI reveals that the number one subject is...Design Control.  So, obviously, it is a widespread concern, and it may make sense to drop on down to the Engineering Department unannounced, and ask to see the Design History File for a product you know is in the pipeline.

At The CRO Group, we have seen the good, the bad, and the just plain ugly when it comes to Design History Files (DHFs).  We emphasize content quality rather than "filling out the forms."  For example, the Design and Development Plan is often some spreadsheet that the project engineer filled out at the beginning of the project, and inserted into the DHF binder.   To a seasoned auditor, the first sign of trouble is often a non-conforming Design and Development Plan.   These plans are infrequently updated, hardly ever revised when new tasks surface, or the project takes a new turn, and are not shared with the members of the project team.   Of course the best time to share the plan with the other members of the team is at the project meetings.  Failure to document project meetings is often the next nonconformity finding for these companies.  What is the number one reason why these things happen?  It basically comes down to this:  The truly creative people in this world are often the members of your design team.  Truly creative people and documentation are like oil and water.

Since we have not met a design engineer yet that truly liked documenting all these requirements, it's your job to recognize this and help them out with streamlined forms that encourage conformance.  How can a form encourage conformance?   At The CRO Group, we have eighteen electronic forms that help you to complete a conforming DHF, and our clients tell us, they really do work.  Here is a sample: Design and Development Plan.  We have risk assessment/hazard analysis forms that support EN1441 and EN60601-1-4.  We have labelling forms that address EN980 and 21 CFR801.  If these documents seem a bit distant to you, it's probably a good time to speak with a partner, or send us an email.  For new companies just starting up, we provide these forms as part of our Quality Systems consulting service.  What about for the established/already certified quality system firms? We also provide them as part of our Design Control Training Seminars.  Again, send an email or contact us to obtain more information.  These forms are not the only solution, but they do make it so design control need not be painful.

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