Page 73 - Biomedical Engineering and Design Handbook Volume 2, Applications

52 MEDICAL DEVICE DESIGN

Subpart I: Nonconforming Product. Procedures must be established for dealing with any prod-
uct found not to meet specification under acceptance procedures. Once again, as in subpart H, this
covers the entire manufacturing process from raw material through finished goods. These procedures
must “address the identification, documentation, evaluation, segregation, and disposition of noncon-
∗
forming product.” The procedure must provide for determining whether an investigation is needed
and whether to notify the persons responsible for the nonconformity.
Your procedure must identify the person or group that reviews the nonconforming product and
determines its disposition, for example, destruction, rework, salvage of parts, etc. The disposition
must be documented.
You must have a procedure controlling rework. It is important to distinguish rework from a
multiple-try process. Some processes call for multiple tries, “polish and inspect up to three times
until product meets specification.” On the other hand, when a product finishes the manufacturing
process and fails, then sending it back is called rework. The specification should state if there is a
limit on the number of times a product can be reworked. Reworked product must meet all tests and
acceptance criteria.

Subpart J: Corrective and Preventive Action (CAPA). This subpart is critical because it is one
of the most heavily inspected activities by FDA. It is considered a major module in an inspection
of a quality system because these procedures are where nonconformities are corrected and, per-
haps more importantly, examined to see if preventive action can be taken to preclude other future
nonconformities.
The difference between Corrective and Preventive Action is sometimes not clear. In general it
might be said that corrective action is that which prevents the same nonconformity from recurring.
For example, if the pull test of a gluing step was missing nonconforming the product, corrective
action might be changing the test to one that can find all errors, such as by increasing the pull weight
or duration. Preventive action could be to look around your manufacturing process for other steps
where similar tests are done to see if any similar processes should be upgraded. Corrective action
looks back at an error to prevent recurrence; preventive action tries to use what was learned to pre-
vent other types of errors.
CAPA procedures covers a wide range of nonconformities. CAPA procedures analyze input from
“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.” This is a wide area of data input. This
†
has led some FDA inspectors to incorrectly treat CAPA as a “system” that must receive input from
all sources. Actually the CAPA procedures need not be one enterprise-wide system, but there must
be a way to determine if data concerning nonconformities found in different areas are related.
Statistical methods may be required to analyze the multiple data inputs to detect recurring problems.
Some inspectors have misread this section to mean that corrective action related to audit reports must
be in your one, unified CAPA system. This is incorrect. Internal audit results may be handled in a
separate audit CAPA process. Nevertheless, the scope of CAPA is immense. Modern quality theory
is expanding CAPA procedures beyond manufacturing to areas such as clinical trial compliance.
Once you have events in the CAPA procedure, subpart J requires
(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 iden-
tified quality problems;

∗ Id. § 820.90(a)
† Id. § 820.100(a)(1).