A successfully run organization stays successful by meeting the evolving needs and requirements of their customers. During normal business cycles, customer needs will change. One way the best manufacturing companies make sure they are meeting current client requirements is by supplying Certificates of Analysis (COA).
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.”
Consider a typical scenario in which a manufacturer wants to change a current product or produce a new product. The manufacturer needs to ensure the product meets stated specifications for a particular customer. After the R&D has been completed and the facility has proven it can produce said product they still need to ensure the most critical specifications or the critical-to-quality trees (CTQ) are met consistently. If the manufacturer has a system to collect pertinent data and assemble it proving the product(s) meets specification then a COA can be created. The problem many manufacturers encounter is the collecting of the data in a timely and accurate way. This is where having an automated COA tied in with a Quality Manufacturing System (QMS) really makes a difference.
Many manufacturers know having the ability to create COAs is an advantage but consider it too costly a proposition. I ask, “what is the cost of not having COAs?”
- Lost customers (current and future)
- Increased time needed when products get recalled or placed on hold
- Less confidence in what gets shipped out
- Audits are longer and more arduous than need be
- Competitors can get the edge when they have COAs and you do not
As you can see in the above list, the price of not having COAs is quite high. Ask any manufacturer who has successfully implemented an automated COA system if they would ever go back to the old way of doing business and you will hear a resounding no!
However, if you produce a product that is a component in your customer’s final product, the real value of a COA program is the competitive advantage you give YOUR customers. Thru COAs your customer knows you back up your quality results with official documentation. This helps them win new business with confidence and simultaneously puts a barrier to entry for other suppliers. Would you rather buy a product from a supplier who says they are behind their product or one who proves it?