CORRECTIVE AND PREVENTIVE

ACTION SUBSYSTEM

CULTIVATING COMPLIANCE
CONFERENCE
LAIZA V. GARCIA
MEDICAL DEVICE SPECIALIST
OFFICE OF MEDICAL DEVICE AND RADIOLOGICAL HEALTH
OPERATIONS
U.S. FOOD AND DRUG ADMINISTRATION
 DISCLAIMER
This communication is consistent with 21 CFR
10.85(k) and constitutes an informal
communication that represents our best
judgment at this time but does not constitute an
advisory opinion, does not necessarily
represent the formal position of FDA, and does
not bind or otherwise obligate or commit the
agency to the view expressed.
 Discussion Topics
• Related Regulatory Requirements Under 21
CFR 820

• Precedent Rationale to Substantiate Regulatory

Requirements

• Applicable Standards and Regulatory

Requirements

• FDA Inspection Approach

• Questions

3
 Regulatory Requirements
Under 21 CFR 820
21 CFR 820.100 (a)(1)
Establish (define, document and implement) and
maintain procedures for implementing corrective and
preventive action.
• Analysis of processes, work operations,
concessions, quality audit reports, quality
records, service records, complaints, returned
product, and other sources of quality data to
identify existing and potential causes of
nonconforming product, or other quality
problems. Appropriate statistical methodology
shall be employed as needed to detect recurring
quality problems.
 Regulatory Requirements
Under 21 CFR 820 (cont.)
What is a non-conforming
product?
Product
21 CFR 820.3(q) Nonconformity Conception /
Developmen
means the nonfulfillment of a t

specified requirement.
Pre-
Production
Activities
21 CFR 820.3(r) Product means
Production
components, manufacturing and Post-
Market
materials, in- process devices, Activities
finished devices, and returned
devices.
Regulatory Requirements
Under 21 CFR 820 (cont.)

What Is Quality?
• 21 CFR 820.3(s)
“Quality means the User Needs
totality of features
and characteristics
that bear on the
ability of a device to Evolving
Adequate Process
satisfy fitness-for-use, Design/ Dictated by
including safety and Production Quality Data
Sources
performance.”
Regulatory Requirements
Under 21 CFR 820 (cont.)
21 CFR 820(a)
(2) Investigating the cause of nonconformities relating to product,
processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence
of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to
ensure that such action is effective and does not adversely affect the
finished device;
(5) Implementing and recording changes in methods and procedures
needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or
nonconforming product is disseminated to those directly responsible
for assuring the quality of such product or the prevention of such
problems; and
(7) Submitting relevant information on identified quality problems, as
corrective and preventive actions, for management review.
Regulatory Requirements Under
21 CFR 820 (cont.)
Analyze
820.100(a)(1)
Submit for
Management Investigate
Review 820.100(a)(2)
820.100(a)(7)

CAPA
Disseminate to Lifecycle Identify and
Responsible Implement
Individuals Actions
820.100(a)(6) 820.100(a)(3)

Permanently
Verify and/or
Implement
Validate for
Systemic
Effectiveness
Changes
820.100(a)(4)
820.100(a)(5)
 Regulatory
Requirements Under 21
CFR 820 (cont.)

21 CFR 820.100(b)
• Requires that all activities to
be conducted be documented.
Other Related Regulatory
Requirements
Satellites concerning the CAPA Subsystem
Medical Device Reporting 21 CFR 803
• Requires to establish procedures for evaluating events that can be
considered as reportable under the MDR requirements.

Corrections and Removals 21 CFR 806

• Requires to report to FDA, within a specific timeframe, actions taken to
address corrections made to products after being distributed.
• Market withdrawal, product correction in the field, retrieval of product from
user facility, product returns amongst others.
• Requires that for actions which were not reported to FDA, a rationale is to be
documented.

Medical Device Tracking 21 CFR 821

• Requires to adopt a method of tracking a class II or class III device, if the
device meets following criteria; and FDA issues an order to the manufacturer.
 Precedent Rationale to
Substantiate Regulatory
Requirements
Quality System Regulation
Preamble Timeliness,
Containment
Comment 159 Actions,
• “FDA agrees that the degree of Scope
corrective and preventive
action taken to eliminate or
minimize actual or potential
nonconformities must be
appropriate to the magnitude
of the problem and
commensurate with the risks
encountered.”
• Relevant when establishing Risk
proactiveness, scope, and (Intended Use and
Performance)
adequacy of actions
implemented to prevent
recurrence.
 Precedent Rationale to
Substantiate Regulatory
Requirements (cont.)
Comment 160 The exception under
• “FDA wants to make it clear that 820.180(c) FDA excludes the
following:
corrective and preventive actions,
• Reports required by
to include the documentation of 820.20(c) Management
these activities, which result from review, 820.22 Quality
internal audits and management audits, and supplier audit
reviews are not covered under reports used to meet the
Sec. 820.180(c).” requirements of
820.50(a) Evaluation of
• It is within FDA’s authority to suppliers, contractors,
review CAPA’s that result from and consultants...”
these activities and these are
be contemplated within the • Procedures for
management reviews,
firm’s CAPA procedures and
internal audits and
established CAPA subsystem. purchasing controls are
also not contemplated
within the exception.
 Precedent Rationale to
Substantiate Regulatory
Requirements (cont.)
Comment 160
• “FDA emphasizes that the • Statistics are not to
appropriate statistical tools justify the exclusion of
must be employed when it is additional actions, or
necessary to utilize statistical inaction, in terms of
methodology. FDA has seen far corrective and
too often the misuse of statistics preventive actions,
by manufacturers in an effort to specifically when
minimize instead of address the
problem. Such misuse of controls to address
statistics would be a violation of recurrence of reported
this section.” problems were non-
existent.
 Precedent Rationale to Substantiate
Regulatory Requirements (cont.)
Comment 166
• “Two comments stated that the records
required under Sec. 820.100(b) should
be treated as part of the internal audit.
FDA disagrees with these comments
because this information is directly
relevant to the safety and effectiveness
of finished medical devices. FDA has
the authority to review such records
and the obligation to do so to protect
the public health.”

• CAPA activities are to be

commensurate with risk; are required to
be documented; and FDA is entitled to
review these. This further substantiates
comments 159 and 160.
Applicable Standards and
Regulatory Requirements
Recognized Consensus
Standards Regulation Standards

•Are non-binding in respect to

requirements under the regulation Statutory Specific to a
and adherence to these is voluntary. Requirement process, device,
meant to be environment, or
•Manufacturers may submit a adaptable. operation. Not
Declaration of Conformity to May exceed mandated by
applicable Consensus Standards that standard law. May
apply to their device and/or exclude or
requirements.
processes. exceed
regulatory
requirements.
Applicable Standards and Regulatory
Requirements (cont.)
• During inspections, FDA may routinely
audit the data or information that
supports the firm’s conformity to the
standard.
• Commonly used standards include:
• ISO 13485-2019 “Medical devices—Quality
Management Systems-Requirements for
Regulatory Purposes”
• ISO 14971-2019 “Medical Devices-
Application of Risk Management to
Medical Devices”
FDA Inspection Approach

Procedural direction form managing CAPA’s

and related activities.
• Are these comprehensive ?
• Did procedures address all potential quality data
sources for evaluation and escalation to CAPA’s as
needed ?
• Are theses consistently implemented ?
• Are these followed ?
FDA Inspection Approach-Cont’d
Comprehensive approach to root cause
determination and subsequent corrective actions
implemented.
• Were all contributing factors and common
denominators evaluated ?
• Processes, products, acceptance activities,
components, workforce, environment, design,
etc.
FDA Inspection Approach
(cont.)
Comprehensive approach for implemented
corrective actions.
• Were all affected product, processes,
components, instructions amongst others
impacted by corrective actions implemented ?

Adequacy of related investigations.

• Risk
• Impact on product performance
• Where lack of controls to prevent recurrence
adequately identified ?
 FDA Inspection Approach
(cont.)
Proportionality of corrective actions implemented to
related risk and product impact.
• Timeliness
• Product scope
• Containment actions
• Additional controls
Adequacy of effectiveness evaluations.
• Is effectiveness quantifiable ?
• Are timeframes to measure effectiveness
adequately established.
• Are the quality data sources selected to measure
effectiveness adequate to detect recurrence ?
 FDA Inspection Approach
(cont.)

• Effectiveness to prevent recurrence.

• Are there repetitive instances
documented on subsequent
and/or separate CAPA’s or
related quality data sources ?
• Documented CAPA activities
• Are investigations, actions,
verification and/or validation
adequately documented to
include objective evidence ?