It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory requirements apply to you, or which ISO standards you comply with, supplier quality plays a fundamental role in ensuring your product is safe and effective. Although design and manufacturing controls are often thought of as the “make or break” processes, if your organization does not have robust supplier quality controls it could have disastrous outcomes.
Arguable one of the largest facets of supplier quality within the MedTech industry is contract manufacturing. Contract manufacturing is essentially outsourcing all or part of your manufacturing processes to a supplier when you do not have the internal resources to complete it. Contract manufacturing is a budding sub-industry that is expected to grow at a compounded annual rate of roughly 11%, from 2020 through 2027.1 With this type of growth, organizations can expect to see the FDA and other regulatory agencies prioritize how these suppliers are managed.
Contract manufacturing is a process that has inherit risk. It is important that you select a contract manufacturer that has a robust QMS, understands the regulatory requirements they are responsible for, and is willing to work with you to accomplish overall regulatory compliance. A large part of supplier quality is how you qualify suppliers, and contract manufacturers should go through the highest level of scrutiny.
Qualifying any supplier should begin with a full understanding of the risk they present to your product/overall compliance status. A contract manufacturer has one of the highest risks since they have the most direct impact on product quality. Other types of suppliers who provide lower risk commodities/services may not require the same level of controls. Part of the controls that should be employed, especially for higher risk suppliers, include audits and enforcing quality agreements.
Supplier quality should be one of your most robust QMS processes, no matter what your product is. If you need assistance keeping up with supplier audits, or improving your overall supplier quality process, EMMA International can help! Give us a call at 248-987-4497 or email firstname.lastname@example.org to learn more.
1Precedence Research (Oct 2020) Medical Device Contract Manufacturing Market Size retrieved on 05/04/2021 from: https://www.globenewswire.com/news-release/2020/10/15/2109290/0/en/Medical-Device-Contract-Manufacturing-Market-Size-to-Hit-US-97-52-Bn-by-2027.html#:~:text=According%20to%20Precedence%20Research%2C%20the,97.52%20billion%20by%202027%20globally.&text=Contra