At one time or another everyone has heard the mantra, “The
customer is always right!”  When a
company is in the midst of a regulatory recall and its new “best friend” is the
U.S. Food and Drug Administration (FDA), the company must clearly understand
that the FDA is their customer AND it is imperative to get the recall “right.”

Over the past year there have been a number of highly
visible recalls that have laid waste to companies who did not meet FDA
standards.  What a company does both
publicly and with the regulatory agencies is critical to an organizations’
ability to survive and thrive.  This is a
true test of resilience as the FDA is not the only concern. People who buy the
company’s products could be the ones to decide their fate.

The FDA and other regulatory agencies have entered a phase
of intense regulatory scrutiny of companies who do not decisively address audit
findings.  The result has been not only
closer scrutiny of the company subjected to the recalls, but to other sites or
business units as well.   These actions
on the part of the FDA make it very clear that they mean business.

However, all is not lost. 
There are effective courses of action an organization can take to
successfully manage current recall status and prevent future recalls.

Assessment of Key Performance Indicators (KPIs)

A company scorecard of metrics for investigations and
Corrective Action Preventative Action (CAPA) is the starting point for the
remediation efforts. Each company does this in different ways and to varying
levels of sophistication.  In order to
assess the scale and scope of the recall, an organization needs to review the
measures, metrics, and trends from the past two years to determine the extent
of the recall.  Some of the data points
needed include:

• Number of open investigations and CAPAs

• Reportable vs. non-reportable incidents (counted by level)

• Time to close investigations and CAPAs

• Resources required to close investigations and CAPAs

• First-time fix rates

• Mean time to resolution (tracked by person-hours)

In order to launch a remediation effort, this information
must be quickly accessible and available to all involved in the remediation
effort. This is crucial for proper analysis of KPIs.

Next, current workflows that impact the recalled product
need to be reviewed. These should include troubleshooting methodology,
performance environment (including the performance system) and performance
support work flows as well as the standard operating procedures (SOPs) for
investigations, CAPAs and investigation training.  This information, along with the metric
information above, will serve as a basis for verifying the improvements
recommended at the conclusion of the project.

Investigation Assessment

Consistency, stability and capability of business process
are necessary to reduce variations caused either by common causes or by
incursion of external factors or special causes.  Analysis of the current business and
investigation processes regarding the use and implementation of CAPA methods –
and root cause analysis (RCA) tools – will identify a framework to address
quality events in a holistic fashion. This will reduce the time required to
complete investigations and provide a blueprint for future CAPAs to be
transparent and traceable and can be adopted at other sites throughout the
company.

To achieve this, a company should start with a structured
review of the organization’s SOPs against past investigations in a “should vs.
actual” analysis to judge outcomes. This structured review includes analyzing
the SOPs as compared to the written investigations, as well as reviewing the
actions of the employees involved.  By
taking an analytical approach, the gaps and shortcomings not found in typical
audits can be identified and addressed.

CAPA Assessment

To continue with the recall remediation, it is important to
assess the company’s CAPAs. That process begins with a review of the SOPs.  Once this is complete, a company should meet
with its CAPA approval team to identify the gaps between the SOPs and the
actual work flows that drive CAPAs as described by the CAPA approval team.  This meeting will yield valuable data that
will help a company zero in on the “sweet spot” for improving their CAPAs.  It is important to note that there typically
is a gray area associated with how to choose the most effective and efficient
corrective action, among the many that are available.  For these decisions, companies should
consider working with outside vendors, who can look at these potential actions
with an objective mindset, thus removing any emotional elements.

RCA Tool Assessment

Integrity of the RCA tools used in investigations is
essential for achieving scalability, repeatability, improved hit rate (wrong
answer less often, right answer more often), and ensuring the use of the least
amount of resources.  Consequently, a
review of current RCA tools and the training programs that utilize these tools
will help identify weaknesses and/or limitations that can hinder the level of
results. This is essential to keep problems from reoccurring. 

Often times, companies use multiple tools to assess RCA,
which can result in experts racing down parallel paths towards the same
goal—determining the root cause. 
However, these experts are separated by “virtual walls” because they
typically work in different functional areas of the company, and the effect of
separation results in redundant work and little synergy.  One solution to this remediation problem is
to establish a companywide RCA tool chest where employees receive training and
have access to the basic set of RCA tools, such as “5 Whys,” Fishbone and
Kepner-Tregoe (KT) Problem Analysis. 
Then, as investigations unfold and possibly become more complex, experts
of particular RCA tools get assigned to the investigation team so they can apply
the more complex set of tools.

In the remediation effort, looking at the complex
interaction between quality investigations and manufacturing production will
greatly increase the probability of effectively addressing issues (e.g.,
unclear investigation reports, lack of detail on findings of root cause, lack
of specific details to get to CAPA, difficult and costly implementation of
CAPAs).  Finally, continuous improvement
in the use of RCA tools and methods will only guarantee a reduction in recalls
if the current RCA tools are in line with human resource training programs. A
review of training manuals and seminars is a key element in any remediation
effort.

Assessment of Roles and Responsibilities in Investigations
and CAPAs

Understanding the people performance and the dynamics of
team performance in current investigations and CAPAs is THE most overlooked
area during remediation efforts.  Our
work with companies indicates this is often overlooked in standard audits.  Yet, when performing a review and remediation
of a company’s Investigation/CAPA processes, this is where most of the time is
spent. 

All meetings associated with investigations and CAPAs, such
as CAPA In-Process Status Reviews, Investigation Reviews, Disposition Meetings
and Problem-Solving, should be recorded in order to obtain a summary
picture.  Once this is achieved,
interviews should be conducted with operators, quality control analysts, supervisors
and quality assurance personnel, to get a better understanding of why people
are not getting the appropriate performance during investigations.

The results and trends from those interviews should be
explored and clarified with focus groups. 
Once completed, a full, and comprehensive picture may begin to emerge
regarding the rewards and consequences the workplace and the quality or the
lack of quality of feedback given to employees. It may also reveal the
encouraging consequences management offers the organization to get to root
cause and close out CAPAs effectively. 

The Performance Environment is an area where the majority of
systemic failures can be found.   Looked
at another way, performance systems, if designed correctly, and with individual
levers pulled appropriately, are the most significant area that WILL ensure a
reduction in the likelihood of recalls AND drive dramatic improvements in a
company’s “in-process” investigations. 
Effective performance systems are the silver bullet for recall
remediation. These need to be in place at both leadership and operational
levels.

Conclusion

In the end, recall remediation is hard work.  Somewhere, in all those previous audits, were
the nuggets of information and “ah ha” moments that, if exposed earlier would
have kept the recall from happening. 
Somewhere during your past efforts, the blinders were left on and issues
were looked at through rose-colored glasses. Now, things have gone sideways in
the worst possible way for the company. All procedures, processes and SOPs need
to be seen through a new set of eyes with renewed passion to get to the bottom
of what is happening.  Unfortunately, in
a recall those new eyes are now many pairs of eyes, some within the company and
many outside of the company. The rush to judgment by many will be uninformed and
very, very damaging, unless the company takes the time to start over and drive
the remediation effort across all aspects of the business.

About the Author:

Michael Curran-Hays coordinates Life Science operations for
Kepner-Tregoe (KT) globally with focus on Pharmaceutical, Medical Device,
Biotechnology, Generic and the Healthcare provider industries.  His area
of expertise extends to business process and operational improvement as well as
strategy formulation.  

Previously Mr. Curran-Hays was director of professional
development, building advanced consulting and training resources for
Kepner-Tregoe on a global basis.

Mr. Curran-Hays joined Kepner-Tregoe in 1998 as a consultant
specializing in analyzing organizational processes, facilitating issue
resolution, designing and implementing project management systems, and
transferring critical thinking skills in client organizations.

His expertise is in cost management, operational
improvement, and strategy formulation. Clients he has worked with include Bayer
AG, Corning,
Johnson & Johnson, Prudential, Sun Microsystems, FIDC, and HCFA.

Prior to joining Kepner-Tregoe, Mr. Curran-Hays was the
longtime president of The Professional Service Group, Inc. He has also been an
independent consultant and a researcher working in both lab and plant
environments at Arco Metals. His executive leadership and consulting expertise
is enhanced by his experience in operational enhancements, strategy
formulation, and the design and administration of cost-benefit analyses.

Mr. Curran-Hays holds a Bachelor of Arts degree from the University of Arizona. He resides with his wife and
children in Camp Hill, Pennsylvania.

About Kepner-Tregoe Inc.

For more than 25 years, Kepner-Tregoe (KT) has collaborated
with Pharmaceutical, Medical Device, Biotechnology and Generic clients around
the globe to achieve and sustain measures that define exceptional operational
performance. In partnership with our clients, the application of our proven
tools and techniques have contributed to significant performance improvement in
Manufacturing, Quality and Regulatory Compliance. KT customized solutions have
produced major improvements in equipment reliability, shutdown and changeover performance.
In addition we have extensive experience in troubleshooting, root cause
analysis, investigations, CAPA remediation and Complaint Handling. Visit www.Kepner-Tregoe.com.