It is interesting to identify engineering trends from our technical support lines. It seems that many of the non compliance issue related to packaging has to do with quality teams letting go of the wheel after the development of the medical device packaging validation plan.
Medical device companies will often assemble a dream team of packaging and manufacturing engineers to develop a sterile device packaging plan under the ISO-11607 guidelines.
These guidelines largely harmonize with the FDA’s quality system regulation’s QSRs. Lately we have been surprised at some of the conversations we have had with engineers through our engineering departments support line, our support line are in place in a effort to to help our customers as they write their IQ.
Through our support lines we receive a host of exacting questions, some that likely exceed the IQ requirements, such as asking us to identify the metallurgy of the base plate of the machine or what gauge wire feeds the power switch. We’re always happy to oblige the engineers as total customer support is the hallmark of our firm.. We too are an inquisitive group and want our customers to share our thoroughness as they develop their sterile device packaging plan.
Our customer’s plans are crisp, clear, well-developed, well-supported, and meet all of the expected “spirit of validation” requirements that is outlined on Part 3:29 of the ISO11607 standard. At the end, these teams develop a medical device packaging plan the is the tour de force of of quality processing. But then something changes; we no longer hear from the customer, as their program has been largely turned over to secondary and tertiary level employees for implementation and preservation. This is where the trouble typically starts. Quality groups, either as outside consultants or internal groups, seem to be diverted to other projects, and often let go of their validation child. Because these secondary and tertiary employees don’t have the expertise, training and education to keep the spirit of the validation alive, the validated process begins to quickly decay. We typically won’t hear from these companies until there’s been a 483 observation or a complete packaging failure to the point of a product recall.
We can’t emphasize enough that a living validation is essential to compliance. Further, if outside consultants are to be brought in for the process of sterile device packaging validation, they need to be on some type of a retainer that will assure that the lifecycle approach to sterile device packaging is preserved. Don’t expect to create a masterpiece in your capable hands, and turn it over to infantrymen to maintain its scope. Indeed not only should this system not decay it is the expectation that this medical device packaging program should continue to improve over time. Taking a Kaizen approach to this validation process is key whereas small but important steps forward are creating a more robust process.
Remember own you medical device packaging plan and do not pass it down to less interested parties. Review often to assure that the process is still sound through medical pouch testing methods such as peel testing and dye penetration. The “Ounce of prevention is worth a pound of cure” trueisuim is a worthy motto from your medical device packaging plan.