40. Certificate of Analysis (CoA)
Certificate of Analysis (CoA) is an evidence of supplier’s final product quality check and can be applied to incoming quality control (IQC)’s reference, and it’s a critical contract between supplier and manufacturing companies’ quality agreement. This section will describe the CoA formulation process with some finer details which QA and RD personnel shall be cautious with.
The general process for CoA establishment is listed below for the complete process
Certificate of Analysis Process Flow
Throughout the Certificate of Analysis formulation, the following elements shall be considered in order to fully assure the Certificate of Analysis is on the full coverages between the company and suppliers.
Evaluate the raw material’s special characteristics and respective acceptance criteria before evaluating the specification. The appropriate testing method shall also be decided, whether it’s from an international standard such as ASTM or JIS.
Trial data between supplier’s trial and RD’s trial shall be cross-verified before finalizing the acceptance criteria and testing method’s reference.
This will be the official contract agreement between company and suppliers. Generally, items such as testing characteristics (whether it’s mechanical or chemical properties), reference testing standard and acceptance criteria shall be recorded within the supplier quality agreement. RD, SQE and supplier representatives shall sign it to make the supplier quality agreement official.
Once supplier quality agreement is official, the Certificate of Analysis will be attached to the shipped raw material for supplier’s final quality control reference check. Certificate of Analysis’ item will be referred to what has been stated from supplier quality agreement.
Meanwhile, the IQC team shall also cross verify the CoA value and internal testing’s IQC value for comparison.
Since the IQC team will initiate the quality test for the respective items from supplier quality agreement. The items shall also be stated in control plan with respective testing method, sampling frequency, sampling quantity and countermeasure if the inspection fails.
During the Certificate of Analysis process, each stakeholder’s responsibilities are listed below by the diagram.
Certificate of Analysis Stakeholder Responsibilities Summary