Ensure patient and operator safety with proper medical device supply chain management.
Medical manufacturers need to:
- thoroughly vet potential suppliers
- measure quality of current suppliers
- make continual improvements
- put shipping and packaging processes in place
This guide will help you successfully manage your medical supply chain.
Conduct comprehensive screening process
Set up a thorough screening process to vet potential suppliers.
Develop a supplier survey as the first step in the screening process. There are generally five areas of interest when evaluating a potential supplier:
- capacity to produce at the levels required
- existence of a Quality Management System (QMS)
- use of controlled processes
- ability to demonstrate performance
- financial ability and stability to provide goods at an agreeable price
(NOTE that price is listed LAST!!! Anyone can negotiate a low price, but not many low price suppliers can consistently deliver on time and within specifications. )
The survey should cover the supplier’s documentation system, incoming material controls, quality assurance process, manufacturing controls, management support and environmental controls. Check out our supplier survey for an example and other potential questions.
Also, request the supplier’s quality manual, organizational chart, ISO certifications, RoHS and other environmental certifications, and a list of equipment.
Perform quality systems audits
Depending on the results of the supplier survey, it may be necessary to perform an on-site audit of potential suppliers.
KMC Senior Supplier Quality Engineer Christine Long explains that an audit “is a means of mitigating our risk of doing business with a supplier and it will provide us with the added assurance that a supplier does have a Quality Management System with documented processes (that if consistently followed) should provide us with products compliant with our specifications.”
Audits also give you the ability to seek evidence that the QMS processes are followed.
Audits should minimally require review of a documented QMS, a documented and compliant calibration process, provisions for inspection/test of product to be shipped, a documented corrective action (C/A) system, and a documented process for document control.
The audit evaluates whether “suppliers have a QMS that will be capable of meeting our standards (do they have a documented quality system that includes processes for calibration of inspection equipment, product inspection, documenting and proper handling of discrepant materials, and C/A documentation change and/or design controls, purchasing and supplier approval processes, etc.?)” Long explains, “I audit them to their own documented QMS procedures to ensure they really are doing what they say they do, and are in compliance with their own procedures.”
The audit should also require as much detail as possible on your suppliers’ ISO certifications, their purchasing processes, resources, work environment, handling of test equipment and more.
Audit critical suppliers at least once every three years to ensure their continued quality compliance.
After moving suppliers through the qualification process, take the following steps to guarantee quality throughout the life of your medical device supply chain partnership.
Measure supplier performance
Keep track of current suppliers with an Approved Supplier List (ASL) and measure their performance.
Determine how you will rate quality, such as comparing total piece parts received to the piece parts accepted. On-time delivery can be rated by comparing the promised delivery date to the actual delivery date.
Determine the course of action if a supplier performs poorly, such as issuance of a Supplier Corrective Action Request (SCAR) form, discussion or removal from the supplier list.
Also, use scorecards and audits to measure performance and make improvements. Each quarter, report on the critical suppliers’ quality performance to assess their compliance to your requirements and to identify their continued ability to meet them.
“I may request a Corrective Action Plan (or some folks refer to it as a Get Well Plan) from a supplier if their quality rating indicates that a negative trend is being seen,” Long said, “so, if it’s a key/critical supplier, I may request a Corrective Action Plan when I issue their quarterly scorecard.”
Make continual improvements
In his Medical Product Outsourcing (MPO) webinar Applying Quality Systems Principles to Improve Supply Chain Management, B. Braun Medical Manager/Quality for Purchased Finished Goods Jonathan Severino stresses the importance of establishing feedback loops to continuously improve your own supply chain management system and improve supplier performance.
Medical supply chain management requires communication. Provide feedback when performance is exceptional and when it requires improvement. Open, honest communication is key. If suppliers value your business, they should be responsive, and if they’re not, it’s time to find new suppliers.
“I don’t like to use the term ‘sustaining’ as it creates the perception that keeping status quo is acceptable,” Severino said, “You should always be looking to improve your supply chain and improve the value they can add to your manufacturing efforts.”
Packaging and shipping your medical product
You may have strict packaging regulations in place, but that can only go so far in protecting your medical product. Once it leaves the manufacturer, it encounters circumstances outside of your control.
In his Effective Supply Chain Management for Medical Device Shipments article for Medmarc, Eric Newman says, “Under FDA regulations and cGMP protocols, the manufacturer not only is responsible for validating the quality of the manufacturing and packaging process, but also for ensuring and documenting that the proper level of care, custody and control is provided when moving product through the supply chain.”
Newman highlights a few ways that medical device manufacturers can ensure the medical instrument’s safety during shipment.
- Hire 3PL transportation service providers that specialize in storing and moving medical technology.
- Develop stringent standard operating procedures. Medical device supply chain SOPs should detail “handling and stowage requirements, transportation service levels, sub-contracting limitations, routing, length of transit time, product temperature/humidity requirements, temperature/humidity excursion threshold limits, maximum amount of time product can be exposed to non-controlled environments during transit, etc.”
- Make a pre-shipment plan for your medical device to assess risks during shipment and create a contingency plan.
- Implement real-time shipment tracking into your medical supply chain management plan to catch any delays along the way.
- Conduct packaging qualification studies to determine the proper packaging of your medical device for shipment to suppliers.
Establish a stringent screening process, perform quality systems audits, measure supplier performance, work with suppliers on continual improvements and determine shipping procedures to maintain quality in medical device supply chain management.
What supply chain management methods do you use? What are some other considerations to take into account when managing your medical device supply chain?