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As a medical device manufacturer, you are responsible for an entire system that moves products from the idea stage to market. Your suppliers play a key role in the process. In fact, during audits you’ll be expected to show how you manage suppliers and ensure that the parts they provide are compliant with regulations and standards and meet your specifications.
I have been on both sides of the equation. I’ve worked at medical device companies that purchase parts from suppliers and at a contract manufacturer that supplies parts to medical device companies. Based on these insights, I will share with you common issues that medical device companies face when dealing with suppliers and ways to better manage the relationship. (Note: Suppliers provide components, materials, sub-assemblies and finished devices. In this article, I will refer to these items as “parts.”)
Choose the Right Supplier
I often discover during audits of medical device companies that they have chosen the wrong suppliers because they didn’t conduct a thorough evaluation or failed to properly complete the often tedious process of getting the supplier added to the approved supplier list. Too often, issues are discovered after the process is complete or after parts are received from the supplier.
Sometimes it’s not apparent that there will be issues until you receive the parts from the supplier. Suppliers could give off the appearance of being able to deliver what you need before you find out that the part doesn’t meet your specifications, the finish isn’t what you expected or there are problems with supply levels. To avoid these issues, get the part in your hands to confirm that it will do what you need.
It’s better to discover that a supplier might not be a good fit before you add them to the approved supplier list. The forms and process for adding a supplier can be lengthy and difficult to complete. Don’t approve a supplier without being certain that they will be a strong match for your company.
Keeping underperforming suppliers on the approved list can cause further issues if engineers continue to order parts from them. That is why it’s important to choose the right supplier in the first place, and immediately remove those that don’t meet your needs. Companies often tend to minimize the approved supplier list, and they’ll instruct associates not to order from another manufacturer if there’s someone on the list who can supply the needed part. Another reason why it’s important to a) choose the right supplier in the first place and b) immediately remove suppliers from the approved list that don’t turn out to be a good fit.
Avoid Common Issues
Problems with approved suppliers aren’t necessarily about product quality. You might face issues on the business side of the relationship, such as reconciliation for purchasing or a lack of communication. Delays in orders could be the result of your company failing to pay supplier invoices, so make sure your suppliers are paid on time. Update team members about potential issues with suppliers to minimize delays and avoid backlogs.
In either case, it’s important that you maintain clear communication with those on your team who need to know about supplier issues. When team members who are responsible for ordering do not know about issues, they’ll likely keep ordering and end up with a backlog.
Complete Regular Audits
Don’t leave out supplier management when it comes to checks. Members of your quality assurance team should review the supplier list annually to ensure that it remains current. Review parts that suppliers send and confirm that items are sent on time and without quality issues. Document the findings of these audits, because you will need to prove that suppliers provide parts that are made to regulation standards during an FDA inspection or ISO audit.
Find the Right Fit
It’s important to have a clear idea of what to look for in a supplier. A strong supplier should respond to you in a timely fashion. For example, when you request a quote or submit a question, expect a reply within 48 hours. Suppliers should also proactively inform you about issues that could lead to unnecessary production delays. Look for value when considering suppliers on the approved list. Assess their cost, lead time and product quality, and make the best choice based on your current business needs.
It’s also best to work with a familiar company. Has someone you know worked with the supplier that you’re considering? Have you seen the parts that they provide? You should always look for proof in the part first (often referred to as a “first article”), unless the supplier comes highly recommended by someone you know and trust.
Managing the Supplier
Maintain a strong working relationship with your supplier that is based on trust and respect to ensure smooth operations. It’s like any situation in life — you get better results when you’ve nurtured the relationship.
As with most things, clear communication is a huge factor. Let suppliers know as soon as possible about issues that arise and be very clear about your lead times, especially if changes occur.
Nurture Trust
Don’t ask for things you don’t really need. For example, avoid the request of an expedited quote or part unless you’re under a true time crunch. You will lose credibility if every request is urgent. Remember, suppliers will go the extra mile for companies with which they have good working relationships.
When issues arise with a part, alert the supplier as quickly as possible as a courtesy before issuing a Supplier Corrective Action Request (SCAR), which should only be used to address risks related to safety and quality. A SCAR for suppliers is equivalent to CAPA for manufacturers — managing one requires a significant amount of work. That said, remember that your company is fully responsible for the quality of the parts you produce. Never hesitate to do what’s right to maintain high standards of safety and quality. However, you shouldn’t face many problems if you’ve been careful about supplier selection in the first place.
Also be aware that many contract manufacturers won’t give you what they consider proprietary information, such as specific equipment settings or exact material formulations. However, you also have a regulatory obligation to have certain information available. You might not receive all the proprietary information you need from the supplier, but you must have confidence and get confirmation that the part was made to proper requirements and specifications. Ask for a certificate of compliance, schedule a tour of the facility, audit the quality of their performance and request a copy of the Device History Record for your files.
Ask suppliers these questions up front: What information will you give me? What will you hold as proprietary? Don’t proceed with the supplier if they’re not going to give you required information. There is a strong likelihood that you will need this information and documented, objective evidence to demonstrate that the part meets your specifications. This may be necessary to support regulatory submissions and clearances. Again, as the manufacturer, you are 100% responsible for the quality of your devices.
The Ultimate Responsibility
Solid supplier management relies upon these key principles: conduct appropriate research before adding a new supplier; communicate early, clearly and often; make sure the part meets your specifications before finalizing the deal; build a relationship of trust and respect.
The quality of your products and supplier relationships has a direct impact on the quality and performance of your medical devices. Make sure that this is an area of your business that you audit regularly, and keep good records for your quality management system.
A version of this article was originally published on greenlightguru.com. Jesseca Lyons is an Operations and Enablement Guru at Greenlight Guru. She’s a Mechanical Engineer by trade who loves working with cross-functional teams in engineering and non-engineering disciplines. She’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry.
