Quality Control

I mentioned earlier that my company manufactures medical device.  Our products and services are highly regulated by all sorts of government regulations and agencies.  FDA, GMP, ISO, CE are all part of the culture.  Change does not come quickly or easily around here.  I’ve often told people that we are so tightly regulated that we can’t change brands of toilet paper without getting FDA approval.  I wear many different hats but my primary role in this place is to buy stuff.  I run the procurement department for the company.  My group's charter is to find and qualify suppliers for just about everything.  From nuts & bolts to equipment to supplies to contracts, everything comes through our little department.  We get to write the checks.  It is interesting to see exactly what we actually pay some of the consultants we hire. 

Being an ISO company, one of the critical aspects of our role is supplier controls.  We have a very tedious and extensive process were we qualify a supplier.  It can take up to several months and requires a thorough evaluation of the prospective company and their systems.  Usually we wind up going to the facility where the parts are made and conducting an extensive systems audit.  That’s another one of the hats I wear.  That is why I am frequently out on the road visiting with various suppliers around the world (hey - it’s a tough job, but somebody has to do it).  Part of my job is to go out to each manufacturer and inspect how they build  the product, how they put things together, how they maintain records, etc.  It is all part of the Quality Control system.  We are ISO 13485 certified (international standards for Medical Device manufacturers) and both ISO and the FDA expect us to maintain a heightened level of control over the products and  processes used to make our stuff.  Quality Control is critical to a company’s reputation and success, especially when it involves medical implants.  We spend a lot  of money and time investigating and exploring suppliers and their quality.  If one supplier cuts corners or creates a defect, it could have a serious impact to our patience, our business.  Recalls seem to be a way of life, especially when it  comes to cars, but in a medical device company it can be the kiss of death. 

That said, I find it mildly interesting/amusing about the saga of Lululemon and their recall of yoga pants.  Lululemon has been making exercise clothing for years has had a recent rash of “sub-par” product out in the field.  It appears that, while the pants have essentially remained unchanged, somewhere in the supply chain, the material formulation has changed and now they are having to recall some portion of their black luon yoga pants because they are a wee bit more “revealing” that originally planned for.  I've gotta give them props for stepping up and owning this.  This faux pas will cost them some serious money but they are working to make this right by their customers.  Normally, I don’t find recalls all that funny but this one just struck me as a wee bit amusing.  If you don’t keep an eye on quality, it may come back to bite you in the end.  Don’t get caught with your pants down. 

Lululemon's quality stand:  Quality is at the heart of everything we do, from the technical features we (sometimes literally) weave into our products, to the people we work with and relationships we build.

Addendum:  apparently this is a bigger crisis than I had originally thought...