TAKING CORRECTIVE AND preventive action in the medical sector

Closed-Loop CAPA: What is the Big Deal? asks Ann McGuire, product marketing manager, Arena


edical technology improves and sustains lives like never before. So, when a problem occurs with a medical device, actions that

correct the problem and prevent it from happening again have to be defined and implemented. For this reason, the FDA requires medical device manufacturing

companies to establish and document corrective and preventive action (CAPA) processes, described in 21 CFR 820.100. All product companies, medical or otherwise, have a closed-loop CAPA process –whether it’s formal, connected, or not. The first part of the loop is the typical CAPA quality process: identify, document, and approve the corrective or preventive action. The second part is taking the actions and updating the impacted systems. Because most CAPA processes relate to one or more elements of the product record, a CAPA system tightly connected with the product record is the most traceable and efficient choice.

INITIAL STEPS: IDENTIFY, DOCUMENT, AND APPROVE THE CORRECTION ACTION In these steps, a cross-functional team determines how to correct a problem documented in a complaint, returned product, quality records, or other sources of quality data, described in 21 CFR 820.100 (a) (1). A quality issue comes from an employee, a partner, or a customer. The documentation includes information including a problem description, the severity of the problem, product identification information (serial or lot number), and relevant usage information, like the operating environment. A cross-functional CAPA team then works to analyse the issue and identify a solution. Customer support and quality teams research this problem, then reproduce it. The quality team proceeds to better understand the root causes. The CAPA team uses the root cause information to determine the best resolution, then documents it. That proposed resolution is then reviewed by the impacted groups for approval. These activities conform with 21 CFR 820.100 (2, 3, 4, and 7). Typically, the solution addresses one or more of these elements –

all part of the product record: Personnel training; Product design; Manufacturing and test documentation; and Purchased product or service.

CLOSED-LOOP STEPS: CHANGE PRODUCT RECORDS, UPDATE DOWNSTREAM SYSTEMS Because CAPA resolutions relate directly to one or more parts of the product record, a closed-loop CAPA process manages the steps to identify, analyse, and resolve product issues while documenting the resolution and linking it to the product record, as described in 21 CFR 820.100 (5). This ensures all impacted teams, from design to purchasing, know about outstanding issues and can easily participate in the CAPA process. A product-centric QMS system provides this

connection between the CAPA process and the product record.

PERSONNEL TRAINING If an issue is traced to an employee or an external team member, training may be the resolution. A product-centric QMS system includes training- record management that notifies the person, tracks training activity, and tests for competency. The CAPA loop closes when the training record is linked with the product record and training plans. Any required changes to personnel training can be documented, corrected, and linked via a corrective action request (CAR).

PRODUCT DESIGN When the team decides the product needs to be changed, an engineering change process manages this resolution. An engineering change order (ECO) describes the change, the reason for it, and tracks the change to the product record. A redlined bill of material (BOM) clearly describes changes to the BOM. The CAPA loop on product design issues closes when the product- centric QMS system links the ECO with the CAPA that initiated that ECO.

MANUFACTURING AND TEST DOCUMENTATION Occasionally, the documentation, like an assembly instruction, does not reflect the most recent change to the product design causing the product problem. In this case, a change order will drive the updates to the document. Change orders list the change descriptions and reasons for them. For documentation issues, the CAPA loop is closed when the change

order links to the impacted documentation as part of the CAPA. All team members can see the change and what started it, and then access the updated released revision of the documentation as needed.

PURCHASED PRODUCT OR SERVICE ISSUES Finally, a problem may be traced to a purchased product or service. If a purchased part or service is the root cause of a product problem, the

“The FDA requires medical device manufacturing companies to establish and document corrective preventative action (CAPA) processes, described

in 21 CFR 820.100. All product companies, medical or otherwise, have a closed-loop CAPA process, whether it’s formal, connected, or not”

34 MARCH 2019 | DESIGN SOLUTIONS 

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