Know what a certificate of analysis is, its importance, and how to make your own.
Published 6 May 2022
A Certificate of Analysis (COA) is a document that communicates the results of a scientific test done on a product such as food or drugs. The COA also lists the chemicals used in the product’s manufacturing and testing and is created to ensure all important regulations are met and complied with.
The main purpose of a COA is to assure customers, manufacturers, and suppliers that the product they are dealing with meets their agreed-upon standards. The COA is provided by the manufacturer and it is based on their capabilities and internal quality standards, the customers’ needs and targets, and, if applicable, the governing quality standard of the manufacturer’s city or country. Most countries require a COA for importing and exporting food products, while for other products such as pharmaceuticals and chemical products, a stricter analysis process is needed. Some countries that implement this are Saudi Arabia and the US.
Although a COA is usually used for product inspections, having a COA is also important for suppliers’ product manufacturing and delivery. A COA can serve as an identification document for products, supporting the labels they come with as a COA has more details, such as the product’s components, their quality, and their purity. When transacting with customers, suppliers can then use their respective products’ COA to explain to the customer the type of product they are receiving. In this case, the COA can also help customers compare the products they received with the instructions they initially gave to check if they meet the prescribed standards.
By definition, a COA is very similar to a Certificate of Conformance (CoC). Like a COA, a CoC is also a document that ensures a product’s specifications and quality are in line with the provided guidelines for it. Required in some countries and industries, a CoC can be produced if one intends to sell their products to other countries and markets as proof of quality assurance and compliance.
However, a major difference between a COA and CoC is their content. While both documents are for quality assurance and standard compliance, a COA is often more specific and stringent in its details. A COA would sometimes include test conditions and specifications based on the provided guidelines, which also makes the products easier to trace.
The authorities issuing the documents are also different. A COA is usually issued by a manufacturer’s quality assurance or quality control personnel who will then ensure the products’ authenticity and that they are fulfilling the prescribed standards set. In some cases, the issuing authority can also come from an inspection agency known by the manufacturer. On the other hand, a CoC can be given by a manufacturer’s authorized person or party, which includes third-party or external laboratories, certification bodies, and experts.
QA Specialist working on a COA
There are many ways to create a COA, as each industry would have different testing methods and quality standards. However, the US Food & Drug Administration (FDA) requires all COAs to have the following elements:
The FDA emphasizes that each COA should also be dated and signed by the authorized personnel from the manufacturer or supplier’s quality unit before release. In case of repacking and reprocessing, the COA should also show their details and include the original manufacturer’s.
For new certificates issued for or by repackers, reprocessors, agents, or brokers, their COAs should contain the details of the laboratory where the analysis was conducted for them, along with the original details and batch certificate that came from the manufacturer.
To help you create your own COA, consider going paperless and using digital checklists to assist you. Using a digital checklist, you can conduct quality checks anytime and use the data collected to validate the quality of your products.
One app you can use is iAuditor by SafetyCulture. Used by industry leaders in manufacturing and other industries, iAuditor is a quality and safety inspection app available on mobile and desktop that allows you to do everything a digital checklist can and more to help ensure that your products meet customer expectations. With iAuditor, you can use your existing Word, Excel, or PDF checklists, or create your own checklists from scratch. Utilize the best practice checklist templates available in the Public Library and edit as you see fit. You can also conduct inspections from anywhere and store your inspection results in the cloud where authorized personnel in your organization can easily access them if needed.
iAuditor also allows you to:
Roselin Manawis is a content writer and researcher for SafetyCulture. She has experience in news writing and content marketing across different fields of discipline. Her background in Communication Arts enables her to leverage multimedia and improve the quality of her work. She also contributed as a research assistant for an international study and as a co-author for two books in 2020. With her informative articles, she aims to ignite digital transformation in workplaces around the world.
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