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  • kimberlywallbank

What I Discovered about “Seamless” Quality Systems Through My Knitting

I usually get hired by a pharmaceutical or medical device company to update a piece of their quality system such as complaint handling or deviation management. I always ask, “How is this piece of your quality system linked to the rest of your company’s quality system and how well are the links working?” I get the usual answer of “Good”, “Fine” or my favorite “That is not the issue.” I ask these questions because one piece of the quality system cannot fully function on its own.

For those of you who know me well, I love to knit. Sweaters, hats, shawls, etc. anything I can get on my needles. I love knitting because I find it relaxing with a desired outcome. I recently made my first sweater where I had to “seam” (not “sew”, not sure why, but I get looks from my knitting community when I say “sew”) the sweater together. I had made seamed sweaters before but not with sleeve caps (aka, the part that covers your shoulder).

A table with yarn and knitting needles.

I tried everything (YouTube videos, math, praying, etc.) to figure out how to get these curved pieces with straight lines and rows in them to fit properly. I thought about not seaming on the sleeves onto the sweater, but then I would not have a sweater. I would have a heavy and odd-shaped poncho. So, not my desired outcome.

I then went to a yarn store for help. Yes, these places still do exist and have something that many other stores do not … knowledgeable staff members. The staff member at the first yarn store wanted to just talk about the theory of seaming the sleeves to the sweater. I knew that already, so I left frustrated without the knowledge I needed to get the job done.

Feeling defeated, I went to another yarn store (yes, I am fortunate to live within 30 miles of dozen yarn stores) to see if they could help. The owner was there and took ten minutes with me and demonstrated the first few steps of the seaming process for me. When I left, I went home and seamed my sleeves to the rest of the sweater to have an actual sweater. Best of all, it fits!

Two Things You Need to Create a “Seamless” Quality System

Ensure Proper and Functional Links:

You can design and implement the perfect piece of your quality system, but if it is not properly linked or “seamed” to the rest of your company’s quality system, it is just a set of instructions on a piece of paper. For example, your deviation management system and your complaint handling program need to be linked to your CAPA system. Otherwise, how would you address the root causes?

Pharmaceutical worker.

For those companies that outsource manufacturing, they need to be linked to your Supplier Management Program. This helps ensure that this important relationship is functioning properly or if you need to take action. And of course, all the pieces need to be linked to your Management Review/ Site Quality Meeting so that the findings can be reviewed for continuous improvement.

Find the Right Expert:

When you go looking for help to update a piece of your quality system, search for the person who not only has the knowledge (theory) but can work through the quality system links with you to get you the confidence you need to know that your overall company’s quality system is functioning effectively.

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