For Medical Devices

Document Sample
For Medical Devices Powered By Docstoc
					For Medical Devices
Five Steps to Simplifying CAPA Documentation
Five steps that can help medical device companies simplify CAPA
documentation processes.
In light of the record number of medical device recalls in 2006 and the FDA’s recent
urging to device manufacturers to double-check all systems related to corrective and
preventive actions (CAPA), the importance of proper CAPA documentation, tracking,
and verification has never been a more relevant topic in the medical device industry. In
fact, the most frequently cited CAPA subsection of 21 CFR Part 820 on FDA 483 forms
in 2006 was 820.100(b), the subsection requiring the documentation of CAPA activities.      1

There are several schools of thought regarding the correlation between the changing
trends in CAPA documentation and the increase in device recalls. Some believe recall
increases are being driven by better CAPA practices. Tim Ulatowski, director of CDRH’s
Office of Compliance, was quoted in the February 2007 “Silver Sheet” as saying,
“(W)hen you get increases in recalls it’s because maybe companies are doing some of
the right things, too, in terms of corrective and preventive actions.” 2 Others believe the
reason is likely related to increased regulation enforcement. “I think medical device
companies are a little gun shy with the ramp up in enforcement at FDA, so they are more
diligent in reporting complaints and quicker to initiate a voluntary recall,” said Matthew M.
Lowe, product manager, medical device expert with MasterControl Inc. “Device
companies have seen more injunctions in the past year than they have for a long time,
so there is a general feeling in the industry that they are being monitored more closely
than in the past.”

Whatever the reason may be, the general trend in the industry appears to be that most
medical device firms are taking adequate CAPA actions but are just not making efforts to
document CAPA activities to the extent the FDA expects. The key to CAPA, therefore, is
found in the FDA’s perspective: It’s not enough to just say that you do it, you have to
document it, too. CAPA actions taken must be thoroughly documented for regulatory
purposes. The flip side of this CAPA coin is that there are other companies that do not
believe their products are subject to device regulation. It is only when the FDA comes
knocking that they realize they are obligated to comply with regulatory requirements and
must have the quality system regulation (QSR) elements in place.

Wherever your device company may be positioned on the CAPA spectrum, there are
five steps that can simplify and streamline the processes involved with CAPA
documentation. Adopting these fundamental measures will help device companies
improve compliance with regulatory documentation requirements and avoid product

1. Automate CAPA Documentation Processes to Increase Efficiency

Any tool that facilitates the collection and centralization of data generated through CAPA
investigations will contribute to the effectiveness and ultimate success of the CAPA
process as a whole. Implementing an electronic CAPA solution will simplify the overall
CAPA documentation process by automating the routing, notification, delivery,
escalation, and approval of CAPAs and any related documentation. An automated
system not only saves resources and manpower, but it facilitates compliance by
streamlining CAPA processes and providing better tracking of all CAPA activities,
resulting in thorough documentation that is easier to generate. The main purpose of the
CAPA software system should be its capacity to securely store documentation and
report on the data generated through investigation processes. It is much easier to
identify harmful trends when data from CAPAs can be effortlessly retrieved and
analyzed. Whether it is an electronic system developed in-house or a proven out-of-the-
box software solution, an effective automated CAPA system simplifies documentation
efforts and makes search and retrieval of documents easier during inspections and

2. Streamline Reporting/Tracking/Verification Capabilities

An effective CAPA solution should provide the ability to track the implementation phase
of CAPAs and verify the efficacy of actions taken. Verification can be dramatically
simplified through the use of a proven CAPA software solution in that all quality events
can be electronically tracked and users can report on events with greater ease. For
instance, if a device company has a specific part that is failing in a particular way, an
automated CAPA system permits users to track complaints without difficulty following the
implementation of a corrective action. Verification that the failure has been rectified is
automatically provided by the system.

Advanced analytics, reporting, and tracking capabilities are integral components of any
automated CAPA system. A CAPA system that has the capability to electronically track
all routing information and data entered into a form allows all departments to view the
CAPA process, identify bottlenecks, and understand the sequence of events during
processing. With a comprehensive system, the revision or approval history of all CAPA-
related documents should be easy to review and the documents should be viewable by
status (i.e. “in process” or “complete”) or by history. If the system allows CAPAs to be
summarized in multiple levels (such as product, department, root cause, etc.) then the
paper trail of CAPA documentation is easier to follow.

21 CFR 820.100 (6-7) mandates that manufacturer’s establish procedures for “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 submitting relevant information on identified quality problems, as
well as corrective and preventive actions, for management review.” 3 In support of these
requirements, an effective CAPA software solution should be able to generate reports
based on validated templates and forward those reports to appropriate recipients. An
effectual electronic CAPA system should also allow recipient receipt and review activities
to be fully documented and readily tracked.

The FDA has emphasized that appropriate statistical tools must be employed when it is
necessary to utilize statistical methodology. An all-inclusive CAPA solution with robust
reporting and tracking tools can support this effort and help medical device companies
avoid “the misuse of statistics by manufacturers in an effort to minimize instead of
address the problem.” 4
3. Connected CAPA: Provide All Departments with Easy Access to CAPA

Because CAPAs tend to be centered heavily on manufacturing and quality, other
departments are typically kept out of the loop until later phases when teams are
investigating a root cause. A CAPA system that connects all departments allows
effective tracking of all incidents that could potentially escalate into a CAPA and provides
a view of those incidents across departments.

A secure, Web-based CAPA system can connect employees, suppliers, contractors, and
any other parties involved in a corrective action. If the automated system allows
customers, vendors, and others outside the company to electronically submit forms that
could generate a CAPA (such as customer complaints or product issue reports) the
ability to track and document CAPA activities is vastly improved.

4. Integrate CAPA with All Quality Processes

A connected CAPA solution should have the capability to seamlessly integrate with other
quality processes (change control, training, customer complaints, audit,
nonconformance, etc.), the result being a more efficient and effective system. For
example, a CAPA that causes a change in product design or function could
automatically invoke new training tasks after the change is approved. Or a customer
complaint that results in a CAPA could be automatically escalated by a connected,
automated system. Such process integration keeps all quality groups on the same page,
making it easier to track and subsequently document CAPA actions.

5. Develop Standard CAPA Protocols

If a CAPA program is to be extended across all departments, the basic CAPA processes
involved must be uniform. Some commercial off-the-shelf (COTS) CAPA management
software solutions include pre-configured best practice forms and workflows that can be
used as is or that may be customized to suit a device company’s specific needs.
Configurable CAPA forms simplify the process of initiating a CAPA by only requiring
completion of fields related to data entry and by limiting users’ views to only relevant
information. A system that includes the capability to automatically launch a CAPA from
another process (such as a customer complaint or audit finding) further streamlines the
CAPA process and provides more thorough and accurate documentation. If the system
can manage and maintain the links between the forms, all parties involved can easily
identify the action that triggered a CAPA and review the completed process. When all
relevant groups are able to view the entire CAPA process from start to finish, it is much
easier for companies to gather data and provide thorough documentation to inspectors
and auditors.

Implementation of these five measures will have a perceptible impact on a medical
device company’s capacity to improve CAPA documentation efforts, but these are not
changes that can be made overnight. The best way to start is to view each step as an
ongoing process in a state of continual progression as the company strives for better
CAPA documentation, regulatory compliance and product quality.

   1. “FDA Urges Device Manufacturers to Double-Check Their CAPA Systems” from
      the June 2007 issue of “The Silver Sheet.”
2. “Device Recalls Reach New High In 2006 As FDA Works On Postmarket Issues,”
   from the February 2007 issue of “The Silver Sheet.” http://www.medical

3. Federal Register, 61 FR:52601, October 7, 1996 [online]:

4. Federal Register, 61 FR:52601, October 7, 1996 [online]: