Our Minnesota senators and representatives on the Congressional Technology Caucus, Democrat and Republican, have signed a bipartisan open letter to FDA Commissioner Margaret Hamburg asking for, in effect, a streamlined, more flexible and transparent FDA approval process. Any time that Michelle Bachmann and Al Franken agree on something, the evidence of a problem must be overwhelming!
Medical device companies are behind this effort but I would suggest that they perhaps look at some of their own processes, notably in the area of packaging requirements, and do a bit of streamlining and flexibility addition of their own. One area of annoyance (for years) has been the often hyped “Material Certification” or “Certificate of Compliance” or some derivative of this title.
The proverbial final straw that precipitated this post came, in fact, earlier this week. Our production team had produced a label qualification run for one of our clients and sent it over to them. The feedback was positive except that we did not meet the requirement of packing the labels on 1,000 labels per roll, with double shrink wrap. Our crime? We had only packed 500 labels per roll in the prescribed fashion. Why? Because only 500 were ordered for the qualification run! We received an email informing us of the egregious oversight, asking for a Certificate of Conformance affirming that we would indeed pack them 1,000 per roll when the production order was placed. Over the years we have shipped this customer numerous labels, most of which were nicely packed 1,000 per roll and double shrink wrapped. When more than 500 labels are ordered, of course.
This incident challenged me to consider what exactly what a COC/COM accomplishes in the goal of receiving the correct label component for packaging and being able to trace it if there is an issue? In this author’s humble opinion it accomplishes nothing.
We typically receive a print from our customer and do a ‘preflight’, a process by which we make sure we can access the label stock called out in the print, that the tolerances are correct, and that the label is producible and repeatable. Change agreements are already in place with most medical device customers. What these certifications basically do is to say, “Yes, per our agreement this is indeed the stock, ink colors, etc. that you called out on your print. It is exactly like the sixty three other lots of this same label that we’ve sent you over the past five years and nothing has varied”. In addition to this invaluable document, which is normally printed out and in an envelope stuck to the outside of a carton, our manufacturing lot number, the key to the critical traceability component, is inside the core of every roll, on the carton, and in every piece of paperwork relating to the shipment.
In the lean/value added process scheme of things, does this scrap of paper, the COC/COM, add any value to the label product? Does it insure correct material? Do we mobilize a detailed traceability process for each label order before the certication is issued, tracing the paper back to its source? No. Some of our more proactive customers agree with that assessment and have dispensed with the cert process for every single order and instituted a ‘Technical Agreement’ in it’s place. This is a legalese filled document, signed by both companies with sub headings such as Supply of Products and Related Information, Validation Requirements, Product Quality Obligations, and Quality Systems. In a nutshell it says that the device company will provide us with prints and specifications, that we will mutually review and agree upon said prints and specs, and that we will not deviate from the print unless there is agreement in writing. It is basically an overall Certificate of Conformance/Compliance.
Using our job number we can trace label stock, ink, and our machine process back to vendor master rolls, ink batches, and which operators at AWT performed each and every operation down to packing the box. As mentioned earlier, this number is all over the place on every label shipment. If there is an issue of any sort, that number is used to access the entire job record including label retains. How does generating a redundant piece of paperwork add to the value of the labels or the package they go on? Is it possible that it wastes the time of customer service, final pack, shipping, receiving, incoming inspection, and quality personnel at both our plant and our customer? Precisely what function does certifying each and every batch perform? Have perfectly good labels needed on the production line ever sat in incoming inspection because someone misplaced the cert? If a batch is certified and there is indeed an error, will there be meaningful consequences? Those are questions that need to be asked, considered, and candidly thought through.
If we are looking to the FDA to streamline their process, we should also embrace the lean philosophy and do some common sense modifications of our own procedures. Relying on the checks and balance of our upstream vendors quality systems, all of whom we have audited, qualified, and yes, certified, would be a great step and send a message that we are serious about getting devices to market quickly and safely.