There have certainly been some tough lessons learned from the current pandemic. For a lot of businesses, a primary takeaway is how planning ahead and having a secondary resource for materials and services is so important in ensuring that the business is capable of meeting customer expectations.
“It's in an organization’s best interest to ensure that its service or material suppliers are providing the highest quality products and services while also conforming to pre-established requirements. This is often accomplished through the use of supplier quality management systems (QMS), which allow companies to monitor supply chains and inspect or audit materials and services at regular intervals” Quote is taken from The Certified Manager of Quality/Organizational Excellence Handbook, ASQ Quality Press.
All quality systems, including FDA, require that manufacturers of medical devices qualify suppliers of raw materials, subcontractors, and consultants. This process should ensure that vendors of these services meet the manufacturer’s requirements for quality as well as compliance. The goal is to minimize risk to the manufacturer for receiving materials or services that could negatively impact the manufacturer’s quality and ultimately customer satisfaction.
In the past, it was not uncommon to line up multiple suppliers for the same raw material, usually due to concerns about running out of stock or a desire to obtain the best pricing. This has given way to working more closely with a smaller number of suppliers in longer-term, partnership-oriented arrangements.
The current COVID-19 pandemic has shown the importance of proactively qualifying alternate vendors in the event that the original vendor is unable to meet the demands of the manufacturer. The entire supply chain was greatly impacted by the pandemic due to both mandatory and voluntary shutdowns of many companies. Dependence on only one supplier caused many manufacturers as well to suffer due to shortages of raw materials and other supplies necessary for keeping business operations ongoing.
The pandemic aside, there are many other issues that could also cause a need to tap into an alternate supplier. Many are the result of the way we use computers and technology.
I recently observed this type of situation in a client facility firsthand while onsite for an audit. The manufacturer received a notification that the one qualified supplier of a major component of the client’s product had suffered a collapse of their computer system responsible for processing orders. The supplier informed the client that it was unable to process orders that had been previously received from the client and It might take some time to get the system back up. The client then went into panic mode since without the material it would fail to meet customer expectations for delivery of the final product. The material had specifications that were very important to the success of the manufacturing process. It proved to be a very stressful situation for everyone in management which could have been avoided by having an alternate supplier already qualified and the material already identified that met specifications.
Planning for unforeseen events by identifying alternate suppliers can ensure that production is not affected, and that just makes good business sense more than ever.
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