Did you know that supplier quality management procedure issues have resulted in 1,111 citations by the FDA since 2008?
142 of those observances occurred in 2018, so the FDA certainly isn’t glossing over this subject. A recent update from deputy FDA commissioner Anna Abram tackled supply chain risks and clearly instructed life sciences companies to work on strengthening the integrity of purchasing partnerships. “Complacency is not an option,” said Abram.
Supplier quality management procedure problems have a clear link to potentially contaminated drugs and risky devices. Poorly managed purchasing partnerships can sink your company in a hurry, and worse, threaten the safety and health of your customers.
Being ignorant of supply chain quality management is dangerous. To arm you with the knowledge to deliver the best medical device quality possible, we’ve compiled a list of the most common supplier quality management procedure missteps at life sciences organizations.
Four Common Supplier Quality Management Procedure Problems
A supply chain is best defined as a series of linked organizations and processes which transform raw inputs into a finished medical device. Supply chain quality management is a series of controls that minimize the risk of quality issues at every stage of the product lifecycle.
Nearly one in six medical device manufacturers who received an FDA 483 citation last year were non-compliant with 21 CFR 820.50, Purchasing Controls. Nearly 15% of cited organizations failed to establish or follow “procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.”
RELATED READING: How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps
Supplier quality has always been among the top citations, but it’s receiving more focus than ever from FDA inspectors. Why? It could be partly due to the industry’s outsourcing trend. Device manufacturers are outsourcing at historically high rates, and demand for outsourced services is growing significantly. Perhaps medical device manufacturers are struggling to scale purchase controls across a bigger global network.
“With the emergence of new markets, supply chains have become more complex,” stated Abram. In the eyes of the FDA, a renewed focus on purchasing controls is first and foremost a quality-driven effort to “put patients first.”
The growing global supply chain offers incredible opportunities for medical device manufacturers, including faster innovation and more competitive pricing. It also presents new risks. Putting patients first requires smart purchasing controls—including a better approach to risk, supplier selection, cost control, and monitoring.
1. Improper Risk Identification
Purchasing controls exist to minimize quality risks. These controls should act as safeguards during every stage of the product lifecycle, from design to distribution. Risks can occur due to product inputs, manufacturing methods, or any other number of causes. An effective supplier quality management process is dynamic and responsive to constantly changing risks throughout the product lifecycle.
Identifying risks should be a cooperative effort between subject matter experts to identify all potential points of failure and assign risks accordingly. Examples of common categories of dynamic risk can include, but aren’t limited to:
- Growth: Rapid growth can result in suppliers who are unable to fill orders due to demand or a shortage of talent resources.
- Facility changes: Issues can occur if a supplier changes facilities or adds a new facility, which likely involves the addition of new equipment and staff.
- Supplier changes: An evolving supply chain can present new risks to quality, timeliness, and cost. Supplier changes may go undetected if a device manufacturer doesn't monitor partnerships or is working with an intermediary.
- IT systems: Effective quality management technology is a powerful tool for communicating with suppliers and identifying risks in real-time. However, failures or changes in the IT systems can threaten communications and transparency.
- Supply chain size: “Long” supply chains with globally distributed sources can increase the risks of input quality concerns due to a lack of oversight.
Manufacturers of Category 2 and 3 medical devices can face unique risks that are difficult to predict before product realization. It’s not always easy to plan controls if you’re relying on complex new technologies with unique risks, which is why dynamic risk identification practices are crucial.
Avoid underestimating risks. 483 observations for CFR 820.50 often happen because inspectors place a higher risk valuation on various components than members of the organization. For example, imagine that container closures are your product’s primary sterile barrier. An FDA inspector would categorize these closures as critical. However, if you as the sponsor don’t categorize these components the same way, your risk oversight is likely to be considered inadequate by an inspector.
2. Inconsistent Supplier Evaluation
Make sure you’re consistent in how you evaluate your suppliers. This doesn’t mean you should evaluate all suppliers in the same way. Instead, it means you should consistently use a documented, risk-based approach to evaluating prospective partners.
Consistency begins in the product design stage of the lifecycle, by identifying the type of product or service you will purchase and what kind of supplier can provide it. Organizations are required by ISO 13485:2016 to consistently apply a risk-based approach to evaluating new suppliers. Specifically, evaluation procedures must include documented procedures for evaluating and selecting supply chain partners according to:
- Product impact on device quality
- A product’s potential risks to finished device quality
- The supplier’s ability to consistently fulfill your requirements
- A supplier’s performance record
Scores in these four areas should be used to group prospective partners according to critical, medium, or low risk. Different evaluation controls may be applied within each category. For example, you may determine that a prospective packaging partner has the potential for critical impact on device quality, while a prospective catering partner is low risk. Partners in the “critical category” may be subject to a full audit, product samples, and qualification studies. Partners in the “low risk” category may not require a QMS audit or a qualification study.
Creating and using a consistent method for supplier evaluation doesn’t absolve your company of partnership risks. It’s simply a tool for effectively screening suppliers before you form a partnership. All supplier partnerships require ongoing monitoring and oversight. However, a consistent, risk-based approach to evaluating prospective supplier partnerships can help your organization comply with ISO 13485. Consistency can also help you avoid jumping into risky relationships.
3. Picking the Cheapest Supplier
Cost control is critical during every stage of the supply chain management lifecycle. You’re wise to consider the costs of a supplier when you’re sourcing partners and on an ongoing basis. Your organization gains an advantage if you can lower costs without sacrificing quality. However, avoid going with the cheapest supplier.
Make sure you consistently evaluate your suppliers based on risk and performance record and have specs in hand before making a purchase. The quality assurance unit should be heavily involved in evaluating supplier capabilities and product samples. A supplier might be your cheapest option, but if their quality system stinks, it will cost you in the long run. You’ll potentially lose money and time if you face parts issues. You could even have to change suppliers, which creates a snowball effect of regulatory submission issues and an effort to demonstrate that the new supplier’s part is equivalent.
4. Sloppy Quality Agreements
Life sciences organizations can be guilty of sloppy quality agreements with suppliers for numerous reasons. A supplier quality agreement should be an airtight outline for a partnership. FDA cGMP does not explicitly require device manufacturers to maintain quality agreements. However, they’re definitely a best practice according to the agency.
21 CFR 211.22(a) states your organization’s quality unit is responsible for approving or rejecting products that are manufactured, processed, or packaged by another company. 21 CFR 200.100 states, “contract manufacturers are an extension of [your] own facility.” Quality agreements aren’t optional if you consider that you’re assuming regulatory responsibility for your supplier’s quality.
A supplier quality agreement is a document that defines the quality obligations of the design owner and the supplier with regards to cGMP. It may contain checklists or SOPs. This document is not the same as a legal agreement between you and your supplier or non-disclosure agreements to protect intellectual property. It should address:
- Partnership details and key contacts
- Scope of partnership
- cGMP and regulatory requirements
- Quality checklists and SOPs
- Audit, monitoring, measuring, and testing schedules
- Confidentiality, non-competes, and intellectual property
- Pricing and cost agreements, including volume discounts
- Design ownership, control, and maintenance
How Qualio Can Help
Outsourcing allows medical device manufacturers to innovate more quickly, and benefit from product expertise, faster time-to-market, and deeper capacity across a global network. Global supply chains can also present unique quality risks. Many organizations are facing compliance hurdles as they expand partnerships, based on the surge of purchasing control observations issued by the FDA last year. Supply chain management isn’t simple, and it’s nearly impossible if you lack standardized processes and systems.
FDA inspectors are looking closely for common purchasing control pitfalls that threaten patient safety, including weak quality agreements or improper risk identification efforts. Qualio is the first cloud-based electronic quality management system (eQMS) built for fast-growing medical device manufacturers based on the latest guidance and best practices for life sciences. Qualio can help device startups and scale-ups manage suppliers with an approved supplier list (ASL) and simplify interactions with partners throughout the product lifecycle.