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  • kimberlywallbank

Like Free T-shirts, One Size Quality System Does NOT Fit All!

Most of the calls for help I receive from small pharmaceutical and medical device companies are for SOPs. Their first question is something like, “Do you have a SOP for complaint handling (or other piece of the quality system they need)?”

My response is always not what they wanted to hear. I do not have off the shelf SOPs like some other companies because one size does not fit all.

Free T-shirts?!?

I was attending a volunteer event where they were handing out T-shirts for us volunteers to wear. I told one of the people at the table that I needed an x-large. I was handed a T-shirt and told that “one size fits all”. I could tell from holding up the T-shirt that it would not fit.

Plus, the T-shirt fit the woman standing next to me perfectly and she looked like one of those fashion models that could have stepped out of a couture ad. I live outside New York City, so it is entirely possibly that she was a fashion model. For those of you who have met me, she and I would never fit in the same size. Except for maybe a scarf or a hat, but a T-shirt … no way!

I did take the T-shirt and of course, I could not even get it on. In fact, I got stuck in it. The woman standing next to me had to help me get out of it.

A rack of colorful t shirts

The same is true with quality systems. What works for a large international company with multiple product lines and product types would not work for a start up with one product in the pipeline. Larger organizations can handle a more complex quality system while a startup would collapse under the complexity (dare I say it … red tape) of that same quality system.

Finding the Right Fit

When these companies call, I offer to perform a gap assessment. Many potential clients have some SOP or process in place so there might not be a need to start from scratch. The gap assessment is designed to document the current process and where it meets and does not meet the required regulations and standards for compliance. The gap assessment gives them confidence in knowing how compliant their current process is.

Of course, not every pharmaceutical and medical device company I speak with has the same state of compliance. Some need a few tweaks to what they have while others need a brand-new process.

A person talking notes.

Once the gap assessment is complete, I provide recommendations on how to address any gaps. In my quest to provide the best recommendations, I ask my clients questions about their business such as: “How big is your company/department?”, “How many products do you have?”, and “What types of products do you have?”

I do this to learn about their organization. I want to ensure that I am providing the best recommendations for their (T-shirt) size.

Need to Double Check Your Compliance Fit?

If you would like to double check your compliance fit, please contact me at I am always looking forward to discussing with companies their concerns and helping them address them or even putting them at ease that their compliance fit is right.

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