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 of the things that’s made me crazy for years is the beloved Material Certification, Certificate of Compliance, or whatever it’s called at your company. I am going to take the controversial position that this document, a piece of paper without which our labels can’t be released to production, is, as my departed Grandpa would say, “about as handy as teats on a boar hog”.
The final straw that precipitated this tirade came earlier this week. We had produced a label qualification run for one of our customers and sent it over to them. The feedback we received was that everything went fine except we did not meet the requirement of packing them 1000 labels per roll, with double shrink wrap. Our crime/transgression? We only packed 500 labels per roll in the prescribed fashion. Why? Because they only ordered 500 for the qual run! We received an email informing us of the egregious oversight, asking for a Certificate of Conformance affirming that we would indeed pack them 1000 per roll when the production order was placed. Over the years we have shipped this customer lots and lots of labels, most of which were nicely packed 1000 per roll and double shrink wrapped. When more than 500 labels are ordered, of course.
My eldest son owns a company in Portland, OR, a wonderful city with 45 beer brewing operations within the city limits. He recently sent me an email exchange with a customer, who had called one of their practices ‘stupid!’. The email to his old dad read, “The good thing about owning your own business is that you can tell people to pull their head out of their ass”. His response to the critical customer was, “Free life advice: you will elicit a better response if you refrain from calling people stupid. Thanks, Erik”. Since I only own a wing tip of the Advanced Web Thanksgiving turkey, I will refrain from any name calling regarding the Certificate of Compliance requirement. I would ask however, that we take a look at just exactly what a COC/COM accomplishes in the goal of receiving the correct label component for your terminally sterilized package and being able to trace it if there is an issue. In my opinion it accomplishes nothing. Zero. Nada. 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 produceable and repeatable. We already have a change agreement in place with most medical device customers swearing on a stack of Bibles with Torahs and Korans interspersed in the stack, that we will change nothing unless we have written authorization from the medical device customer. What these certs basically do is say, “Yup, per our agreement this is indeed the stock, ink colors, etc. that you called out on your print. It’s exactly like the 63 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 (or turkey?), 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 cert is issued, tracing the paper back to Aspen tree #435 on the SW of the SE 40 acres, Section 18, Town of Oulu, Bayfield County, Wisconsin? My answer to those questions would be 1) No, 2) Nope, 3) Hell 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.
I’ve tried to shoot holes in this technical agreement process but have been unable to. 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 AW 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? Do ya think maybe 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 (humans involved here folks) will there be fines, suspensions, and a visit from the CAPA Police? Those are questions that need to be asked, considered, and honestly thought about. When I run through that question set I come up with the conclusion that the whole process is stu…….oops, poorly thought out.
I know that the Certification windmill will never succumb to my Don Quixote-like tiltings. This very day we will dutifully generate some BS document, affirming our intent to rewind 1000 labels per roll (maybe also asking for deviations on any future engineering/qual runs signed and notarized by multiple company officers) and there will be muttering and snide comments made. But 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.