People tend to use the term “Quality” as a catch-all for any function that makes sure we get things right. Under that umbrella, Complemar uses different kinds of Quality methods.
Quality Assurance is the term used to describe the maintenance of a desired level of quality in a service or product. That is, we make sure that the process is set up to produce the desired outcome, especially by means of attention to every stage.
Quality Control is a system of maintaining standards by inspecting a sample of the output against a specification. For example, QC is used when we get first-piece approval, or when we check incoming materials for the right quantity and condition, or when we check that outgoing materials have the right paperwork.
Quality Management System
System Quality is an organized effort to manage how businesses provide products or services they sell. Its primary goal is to ensure that companies act responsibly and have the organizational structure, procedures, processes, and resources in place. That’s what Complemar talks about when we mention “ISO.” ISO 9001 and ISO 13485 are sets of stringent quality management system requirements that we comply with.
In our business, we also look at how well we control our inventory. It’s vitally important to our customers (and to their customers) that we know exactly how much of their stuff we have on hand for them to sell. We ensure Inventory Quality by carefully keeping track of where we put things away and where we pick them from (Quality Assurance). Additionally, we perform cycle counts and random location verifications to double-check that customer property is where it’s supposed to be (Quality Control).
These quality functions are in place to make sure we satisfy our customers.
Complemar has the advantage of being certified to the ISO 9001 international quality standard that ensures we have systems in place to meet our customers’ needs. Most other fulfillment providers are not certified, which means we can easily affirm to our customers that we have top management committed to quality. We have a Quality Policy that promises our customers, “Flawless Execution, Outstanding Customer Service, Continual Improvement.”
Part of the certification process is to get audited every year by an impartial third party. Typically, the auditor is on-site for a few days. They tour the facility to get a feel for what we do, look at our work instructions and records, and ask lots and lots of questions to anyone they see. They point at equipment and ask how it’s maintained. They signalize at people and ask how they’re trained. They point at activities and ask what’s going on and how do we know they’re being done correctly. This year’s audit in Rochester, though, wasn’t typical.
Our recent audit was done remotely. One can’t be much more socially distant than being hundreds of miles apart working through computer screens. Honestly, I think the auditor had a tougher time than we did. We did what we always do: we answered questions and provided documents. But the auditor had to do his job without being able to point at things and people. He had to rely more on his past experiences with our company and the other companies he’s visited. He had to depend on his ability to obtain answers without getting those non-verbal cues like facial expressions and body language that we all typically use when interacting with other people.
This year’s tour consisted of a video call with the camera pointed at a packaging line. We had to decipher whether we had to move to his left or ours, and we were constantly asking him to repeat his requests or questions as the phone’s speakers were drowned out by the sounds of activity on the floor. That was probably the shortest tour I’ve ever give. It’s a good thing he’s been here before. Still, he said he got what he needed.
Despite the COVID-induced barriers, the audit was a success. The auditor was satisfied that we have a solid quality system in place, and we identified ways we could make our services even better. Through continual improvement, our customers get outstanding service, flawlessly executed.
But the quest for quality doesn’t stop there! Every Complemar site gets audited as well. Our Sparks, NV location will go through the same remote audit process in a few weeks that Rochester just went through. Even though we like to be “audit-ready” every day, we still take extra time to make sure every “I” is dotted and every “T” is crossed.
We’re not done with auditing yet. We take time to formally audit ourselves. Nobody knows what we do better than ourselves, so who else could dig to find the opportunities to improve? Representatives from each department participate to help keep the observations objective. Quality might audit Operations, but we don’t audit ourselves. Maybe someone from Purchasing will look us over or maybe one of Project Managers will take on that task.
Rochester isn’t done yet for the year, even though we just had an audit. Rochester is home to Complemar Healthcare, which specializes in satisfying the needs of our biopharma and medical device customers. That means we step up our game a little more and get certified to another ISO quality standard, ISO 13485, “Medical devices — Quality management systems — Requirements for regulatory purposes.” We’ll be audited in the fall to make sure we meet the supply chain requirements our customers want for packaging, fulfillment, and shipping to meet their applicable government regulations.
While nobody likes to be audited, Complemar takes them in the spirit of improvement in which they’re intended. That’s one way we make our operations and systems better for our customers.