Part 7 is the last article in our blog series of key strategies for successfully passing NMPA inspections. In our
previous blog, we wrote about the verification of the QMS for Good Distribution Practice for Medical Devices based on updated GDP regulation. In this blog, we will walk you through the findings and results published by the health authorities NMPA in recent years. Being aware of common findings is a valuable approach for manufacturers to assess their quality systems and identify potential issues during internal audits, ensuring they are well-prepared before the authorities conduct an inspection.
Although the NMPA defines findings and observations somewhat differently than the ISO 13485 terminology mentioned in our earlier blog series, the underlying concern remains focused on risk. When we examine non-conformities identified during authority audits, the most common issues arise in areas such as product design and development, production management and quality control, document management, and purchasing. By learning from past issues, manufacturers can gain valuable insights into common problems and develop effective preventative strategies.
Design and development: Two common findings in the design and development section are lack of control on design change and design transfer.
- When a third party is involved in product design, manufacturers often face challenges in transferring the design process to the local site or fail to provide proper transfer records. Additionally, there may be issues where the design output does not fully align with the design input requirements or the local product-specific guidance, and output validations may be incomplete. For example, design validations might include only the test protocols and reports, overlooking the clinical evaluation, or vice versa.
- Design changes often lack proper review or fail to adequately assess their impact on the final product's safety and effectiveness. For example, companies may not apply a risk-based approach to determine statistical techniques for defining sample size during the re-validation process when changes occur. Another common issue is insufficient control over software change validation, particularly when updating manufacturing software.
Take away: Change control and its impact on the risk management process shall be robustly maintained. The authority may extend the inspections to R&D partners and 3rd party suppliers such as sterilization provider or packaging materials vendor. Foreign manufacturers shall coordinate with their partners to enable the access of documentation and extended inspections.
Production management:
- Production records are often inadequately maintained, failing to meet traceability requirements. For instance, instead of recording detailed part or batch numbers for key raw materials, only generic names are noted. Another issue is the lack of documentation or calibration of installation or operational equipment used in production, which is necessary to verify their qualifications.
- The special production processes are not adequately identified in the production flow chart. According to the NMPA definition, critical processes are those that play a vital role in product performance and quality, while special processes require external validation efforts. For example, welding in the production of a supportive brace is considered a critical process, whereas sterilization of a hip implant is classified as a special process.
Take away: Adequate documentation and evidence of control are essential to demonstrate that the product conforms to its specifications. Clear, concise, and comprehensive records can greatly streamline this process. Additionally, the actual manufacturing process must align with the process registered with the regulatory authority.
Quality control:
Quality control involves a set of activities, ranging from testing, inspection, and documentation. Adequate procedures should be in place to ensure that products are manufactured consistently and meet the established standards.
- The testing equipment used has not been labelled or calibrated properly or the timely calibration records are not available. Or the testing equipment usage records are not well established or maintained. During the testing process, the sampling tests have not been done based on the pre-determined requirements, or the original test results are not recorded.
- Another issue is that the process validation has not been set up adequately, so the produced results may not be consistent, reliable or repeatable. For example, the performance testing validation protocols and test results are not fully meet the pre-set functional parameters requirements.
Take away: Ensure the quality system is functioning optimally with ongoing quality control procedures review.
Document control:
- Inadequate recordkeeping is one of the most common findings. This often means that records are incomplete, inaccurate, or not up-to-date to properly document the manufacturing and quality control processes. For example, documents may lack version numbers, use incorrect versions, or fail to discard outdated documents promptly. Additionally, some locally created documents are not controlled under the master document management system.
- Traceability is important for auditors to consistently track and verify a component from purchase through bill of material management, production, quality control, and into the finished product. The best practice is to attach drawings, material lists, and quality acceptance criteria as appendices to the quality and contract manufacturing agreements, especially when using contractors. It's also important to specify key component part numbers in purchase agreements to ensure traceability throughout the entire production process, rather than relying on generic product names.
Take away: Detailed documentation of procedures and clearly written records are essential to help the auditor to understand the company’s process and review them in a traceable manner.
Purchase:
In the purchasing process, effectively managing critical suppliers and ensuring that procured components meet the required standards are key challenges.
- Supplier selection, management, and re-evaluation often do not align with internal vendor requirements, or the evaluation records are poorly documented. Additionally, supplier qualifications may not be thoroughly reviewed and archived, and regular audits of key suppliers may not be conducted in a timely manner.
- The product specifications outlined in the purchase agreement sometimes do not fully match the final Product Technical Requirements. For instance, a key component listed in the approved technical documents may not be traceable to the procurement records due to inconsistent naming, making it unclear whether the different terms refer to the same product.
Takeaway: It is essential to consistently review and update procurement management files, and to cross-check purchase orders, shipment invoices, arrival acceptance receipts, and submitted technical documentation across departments to ensure consistency.
Becoming curious about what the NMPA inspection process entails?
Read our blog series - 7 parts:
Part 1. China NMPA inspection types
Part 2. China NMPA inspection process
Part 3. Preparation for China NMPA inspection
Part 4. Verification of the QMS for Medical Device Registration
Part 5. Verification of the QMS for Medical Device Production
Part 6. Verification of the QMS for Medical Device Distribution
Part 7. China NMPA Inspection Results and Common Findings
Identifying hidden issues within your quality system is a great first step towards improving your processes and identifying the potential areas for improvement. At Qserve, our experienced auditors are ready to assist with gap assessments, mock audits, quality management improvements, and interim support. If you need expert quality support, don’t hesitate to reach out to us!