Things to Consider/Benefits of Developing Your Certificate of Analysis (COA)

By David Wilt, Manufacturing Solutions Architect, InSource Solutions

In a previous blog, I discussed the competitive advantages and benefits of utilizing COAs. In this communication, I will be looking at details to consider when configuring your COA.

For those who may have missed my first blog, COAs are defined as “documents issued by Quality Assurance that confirms a regulated product meets its product specification. They commonly contain the actual results obtained from testing performed as part of quality control of an individual batch of a product.”

I recently spoke with Felicia Adams, Rich Products Quality Systems Manager.  Rich Products is a $3.7 Billion food manufacturer. Felicia is a recognized leader in the development of Quality Systems which include the use of automated COAs. Felicia provided these bullet points which are helpful for anyone considering the deployment of a quality system including COA use.  Although the details address a food manufacturer needs there are common threads that can be applied to most any industry.

Details to consider:

  • When a product must meet X requirements, this can be microbiological for Food Safety, and Performance (product quality)
    • For Micro this can be costly, and the supplier may not do this or will charge the customer additional fees for it.
    • Depending on the significance of the customer relationship, a supplier may choose to absorb the additional cost.
    • If a Supplier does not want to provide a COA for micro’s it can be a leading indicator of uncertainty and customer will source another supplier
  • Customer tells supplier what is needed on a COA with the intent the Supplier can meet the criteria. This helps clarify customer expectations.
  • A COA provides written documentation that a product/batch/lot meets customer key CTQs (critical-to-quality trees). This is considered a legal document and can be very helpful as a reference in event that a product requires withdrawal or recall.
  • A COA also confirms that a supplier has reviewed the production and/or test data and it is within specs. There is additional high-level accountability since the (COAs) are signed by usually QA manager or proxy
  • A COA confirms that the supplier can consistently produce product to a measurable spec.

It is important to consider the COA cycle as it applies to manufacturing. Below is a simple diagram demonstrating how COAs from incoming product- to processing- to testing-to shipping.

As we can see, COAs can be involved in the entire supply chain. Suppliers that create COAs likely expect COAs on their incoming material. Testing is performed on the customers products and data gathered to confirm/reject that the product meets COA requirements. Ultimately, the approved products are shipped expecting to be accepted at the customer’s site.

The manufacturing cycle that includes COAs has distinct advantages, so as you embark on your COA journey be sure to consider the big picture of what you expect without forgetting the details that will make you a preferred vendor on your customer’s list!

Learn more about the benefits of a successful COA program here.