Whether your medical device company is new to the MDSAP program or has participated for a few years, audits present an opportunity for continuous improvement of your quality system. However, audit findings can lead to lengthy corrective actions and major costs, so proactively avoiding pitfalls is critical. This post highlights common mistakes and potential non-conformances seen during MDSAP audits, organized by chapter, to help guide your company to be audit ready.
Chapter 1 Management
Task 2- Management Representative.
Per the MDSAP guidelines, top management should be appointing a management representative for the organization. A common mistake we see is that the management representative knows they have been assigned this role but is unable to produce documentation showing this appointment. Ensure you document the management representative by name, position title, and responsibility within a formal document such as the Quality Manual, memorandum to file, or job description.
Task 3 – Quality Policy and Quality Objectives
In Task 3, manufacturers are asked to verify quality objectives have been set and are measurable. A common pitfall is quality objectives being set without objective success criteria. For example, if you set a metric for timeliness of nonconformance investigations, there should be quantifiable success criteria, such as “90% of nonconformance investigations must be completed within 30 days of initiation.” A simple objective stating “Nonconformances will be completed in a timely manner” will be insufficient here.
Chapter 2 Device Marketing Authorization and Facility Registration
The biggest gap seen in chapter 2 is around notifying regulatory authorities of changes made to product, facility, or process. Be sure to have a documented procedure in place that defines significant / substantial changes and the appropriate method to submit a notification or submission. Less commonly accounted for changes include (but are not limited to):
- Change to the name or location of the manufacturer
- Commercial name
- New software version
- Inclusion of a new device in a family of medical devices already approved
- Inclusion of new accessories
Chapter 3- Measurement, Analysis and Improvement
Task 5- Correction, Corrective Action, and Preventive Action
In this task, manufacturers are asked to confirm that corrections, corrective actions, and preventive actions did not adversely affect finished devices. This assessment should be documented as part of your CAPA or nonconformance. To further meet specific ISO 13485 requirements, ensure there is confirmation in your documentation that any reworked product was re-inspected or assessed to the original product specifications following completion of actions.
In a similar vein, Task 8- Identification and Control of Nonconforming Product asks manufacturers to confirm that an appropriate disposition was made, justified, and documented. The key miss here is for concession dispositions. When a product is accepted under concession, confirm your records include an assessment of regulatory requirements impacted by the now accepted nonconformance. Ideally, a regulatory person would complete the assessment and documentation to prove that a person with adequate qualifications gave the OK. However, any qualified person should be able to make this assessment with justification.
Chapter 4 Medical Device Adverse Events and Advisory Notices Reporting
Task 1- Notification of Adverse Events
The most common miss we see in this chapter is not adequately documenting the criteria used to make an adverse event reporting determination. Your procedure or software system should document the set of criteria being utilized (e.g., your decision tree). Ensure these criteria can be printed or made available to the auditor. Additionally, your procedure or software system should clearly define the required timeframes for reporting, per each of your relevant jurisdictions. Even if some of the timelines are the same, MedLark recommends listing the timeframes per market, so it is clear to an auditor that all locations have been considered in your process.
Chapter 5 Design and Development
Task 5 Design and Development Input requires manufacturers to ensure that design inputs include applicable regulatory requirements. The most common pitfall in this area is not updating product design files over time. For example, products that are older may have been grandfathered into your QMS. But chances are, if you are participating in the MDSAP program, you may be selling into a few more markets now than when the product was introduced in the 1970s or 80s. Be sure to update your design documentation when a new market is added and include the regulatory requirements for that jurisdiction.
The second common miss we see in design is Task 14- Design Review. Most manufacturers have a design and development process in place that includes provisions for design review. However, the subtle and easily missed piece here is to include an individual at each design review that is independent from the design stage being reviewed, and any relevant specialists needed. If no specialists are needed, MedLark recommends including a justification for no specialists being included in your design review documents.
Chapter 6 Production and Service Controls
Chapter 6 is a big chapter and has many opportunities to miss requirements. Task 4- Control of Product Cleanliness requires manufacturers to assure that process agents are removed from the product if required. Such agents can include mold-release agents for injection molding, machining lubricants, proteins, or residues from cleaning chemicals. If you utilize any process agents in your manufacturing that come into contact with product, ensure a cleaning or biocompatibility validation is in place to verify adequate removal of the chemical or agent.
Task 7- Identification of processes subject to validation also concerns controls within the manufacturing environment. The common mistake we see here is not documenting adequate training for temporary workers within your manufacturing environment. Note that these temporary personnel can include maintenance people. If maintenance or other personnel are required to work temporarily under special environmental conditions (e.g., in your cleanroom or other controlled areas), these individuals must be appropriately trained or supervised by a trained individual. Document the training and / or supervision in the employee training or supplier file.
Task 14- Impact Analysis of Monitoring and Measuring Device Found out of Specification looks for manufacturers to confirm that calibration is traceable to a national or international measurement standard. This includes calibration performed by suppliers. When qualifying a calibration supplier, confirm they are using a documented standard, and include the standard reference within the calibration documentation. Additionally, when equipment is found to be out-of-tolerance, manufacturers must assess and record the validity of previous measuring results and take appropriate action on the equipment and any product affected. Many manufacturers do not include this assessment as part of their nonconformance or out-of-tolerance investigation. Most perform an investigation and include actions to address the issue going forward but forget to address the retroactive piece. Be sure to justify why product continues to be safe and effective, and link to your other processes for health hazard evaluations or recalls if product in the field could be impacted.
The final miss we see in Chapter 6 is under Task 20- Customer Property. This task asks the medical device organization to implement controls to identify, verify, protect, and safeguard customer property. The critical miss here is not accounting patient information and confidential health information as customer property. Document the controls in place for safeguarding patient health information in your procedures, in the complaint process, customer service process, or elsewhere.
Chapter 7 Purchasing
The final MDSAP chapter includes Task 5- Selection of supplier based on ability of the supplier to satisfy the specified purchase requirements. In Task 5, there is a Canadian requirement for any regulatory correspondent used by the manufacturer to be treated as a supplier and adequately qualified. This is becoming a more common miss, especially with the MDSAP, UK MDR, and EU MDR requirements for authorized representatives or correspondents for foreign manufacturers. In many cases, manufacturers use sister sites or partner locations to perform these roles, but do not have supplier documentation in place to qualify, evaluate, and continuously monitor these regulatory correspondents.
Conclusion
Addressing common problem areas proactively is the key to optimizing your MDSAP audit performance. By shoring up common gaps, companies can showcase a mature quality system ready to meet global compliance challenges.
If your firm needs additional guidance tailoring these recommendations to your specific processes and products, MedLark is here to help. Please reach out to schedule a consultation on enhancing your audit readiness. We can conduct a gap assessment and provide tailored solutions to have your quality system audit ready. With thorough planning and expert support, your next MDSAP audit can be a valuable opportunity to drive continuous improvement.
Medical Device Consultant | Regulatory & Quality System 
Leave a comment