Q: In one of your training classes, you mentioned the importance of establishing data linkages between the various quality subsystems of our overall Quality System. Can you explain further and provide some examples?
A: FDA believes these four quality subsystems should be the foundation of every firm’s quality efforts:
- Management Controls
- Design Controls
- Corrective and Preventive Actions (CAPA)
- Production and Process Controls
To realize the full value of these subsystems, you must reinforce them with data links. In other words, you should interconnect and leverage the quality subsystems with the relevant data they naturally produce.
Start by developing a process flow diagram of your entire quality system, then track how you want the data to flow. Look at your procedures to ensure they support fast and accurate data transfer among your subsystems.
In doing so, you’ll likely spot gaps in both the links and in your procedures.
Below is a simplified diagram of the quality subsystems approach. Notice the CAPA system resides squarely in the middle.
All of your subsystems should send data to your CAPA subsystem and — correspondingly — the data you collect and analyze under CAPA should flow back to inform and improve the other subsystems.
– From your Design Control subsystem, production specifications should flow into your Production and Process Controls subsystem. In return, data reflecting the real-world experience of making products should flow back into design control.
Design control also should feed your CAPA subsystem, because design should dictate what data you collect and review for continual design improvement.
– In your Management Controls subsystem, create inbound links from nonconformance data identified by internal audits conducted under CAPA.
Use management controls to review all recommended corrective actions, and look for warning signs of additional deficiencies in your quality system.
Additionally, use management controls to double-check how thoroughly you are investigating the root causes of nonconformances flowing from your CAPA subsystem.
– In your Production and Process Control subsystem, make sure design changes and engineering revisions flow quickly to the production lines. In return, feed nonconformance data from your testing stations into your CAPA subsystem. You should be testing incoming components, in-process assemblies and finished products.
You also want to ensure your Management Controls subsystem reviews all concerns about production yields and efficiencies.
A well-linked CAPA subsystem often will suffice, but some seemingly harmless production problems might be shielded from the “quality folks”, including product concessions — products deemed OK for release despite some degree of nonconformance.
“Make your Production and Process Controls subsystem a gold mine of production data. Then let your CAPA and Management Controls subsystems decide what’s important and what’s not.”
Make your Production and Process Controls subsystem a gold mine of production data. Then let your CAPA and Management Controls subsystems decide what’s important and what’s not.
At least once a year, as part of your management controls, take a step back and critically evaluate your quality subsystem and their connections.
Why go to all this effort? Ensuring the safety and effectiveness of your products is by far the main reason, but here’s another reason: FDA believes a firm’s attention to the four core quality subsystems provides one of the best indicators of its commitment to QSR compliance.
Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and who was co-editor of FDA’s Investigations Operations Manual, which is updated annually as a resource for FDA’s own investigators. Denise is the lead instructor for EduQuest’s training class on QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality System Regulation.