9. DON'T HESITATE TO RECALL, BUT BE PREPARED BEFORE YOU DO IT
Toyota example: Toyota is in the midst of one of the largest automobile recalls in history. Although a recall obviously is an unfortunate
occurrence that will adversely affect customer confidence, a firm-initiated recall is actually a responsible corporate action.
It is the responsible firms that initiate recalls.
Lesson for Pharma: The FDA has specific recall regulations regarding a firm-initiated recall.9 A recall will generate a lot of publicity, so a firm should be prepared with a solid policy and procedure to handle the
details of the recall event. If not handled properly, a recall can easily spin out of control. A high profile recall will
have some unpleasant consequences, such as opportunists trying to cash-in. Be prepared.
The best preparation, of course, is to avoid recalls altogether by following appropriate manufacturing quality regulations.
To avoid manufacturing-related defects in drugs, FDA regulations require that companies follow current good manufacturing
practices (cGMPs). The FDA's recent emphasis on bringing greater control to manufacturing through the use of process analytical
technology (PAT)—in-line and on-line analytical instrumentation with software to analyze data and effect control—and improving
process understanding through Quality by Design—raises the bar even further for improving manufacturing quality.10
To avoid design flaws in medical devices, the applicable regulations are the "design control" sections in FDA's Quality System
Regulation (21 CFR 820), and the international quality management standards ISO 9001 and ISO 13485. Design validation is required.
New medical devices that are part of drug–device combination products are increasingly dependent on software. The FDA is sensitive
to the importance of software and is increasing its scrutiny of medical device software, requiring a system-level hazard analysis
and software validation before granting clearance to market.
The allegations that Toyota's problem related to software problems highlight the importance of software validation and suggest
that designing in manual overrides is recommended.
10. THE COMPANY, NOT THE FEDERAL AGENCY, IS RESPONSIBLE
Toyota example: In the case of the Toyota recall, the National Highway Traffic Safety Administration (NHTSA) came under criticism for not
having seen the problem coming and for not doing more.
Lesson for Pharma: We should recognize that primary responsibility for the identification and prompt handling of field problems resides with
the firm. It is easy to try to blame the regulatory agency, but the regulatory body is just a check on the system, not the
responsible party. That is why the FDA allows a firm to make an expeditious change in warnings or precautions in product labeling
by using the "Supplement—Changes Being Effected in 30 Days" provision.11
The challenge for the FDA is to keep up with rapidly changing technology. Frankly, the greater expertise resides in private
11. KNOW AND OBEY THE RECORDKEEPING RULES
Toyota example: Toyota has been accused of withholding documents from plaintiff attorneys that reflect on safety. Toyota disagrees with those
criticisms, because it considers documents related to engineering design to be proprietary and confidential.12
Lesson for Pharma: There are regulatory and legal requirements to maintain records for specified times and to make them available to regulatory
authorities and for some court proceedings. Pharmaceutical companies must maintain records for 10 years of all adverse drug
experiences known to the company, including raw data and any correspondence relating to adverse drug experiences.13 These raw data and correspondence include emails and even notes written on desk blotters. When you are putting something
in writing, think through your statements carefully and avoid emotional language.
12. CONDUCT A GOOD RISK ANALYSIS
Toyota example: Could Toyota's recent quality problems have been avoided? The answer is "probably yes," if an effective risk analysis had
been performed at the design stage, before large-scale manufacture.
Lesson for Pharma: FDA and ISO standards and guidelines call for risk analyses. In the lifecycle of a pharmaceutical device, the best opportunity
to perform a risk analysis is at the design stage, before scale-up. One very useful tool is failure modes and effects analysis
(FMEA). The FMEA technique incorporates a brainstorming session to uncover potential failures, which are then scored for severity,
likelihood of occurrence, and whether there are any controls in place to detect a failure. The end result is a punch list
of potential failures that require preventive actions to avoid later problems.
Future university graduate management programs will discuss the Toyota Recalls of 2009–2010 as a case study in what to do
and what not to do when a technical malfunction results in a major recall. Lessons will be learned.
"We learn wisdom from failure much more than from success. We often discover what will do, by finding out what will not do;
and probably he who never made a mistake never made a discovery." Samuel Smiles (1812–1904).
Robert N. Borghese is the president of Borghese & Associates, Whitehouse Station, NJ, 908.534.5354, firstname.lastname@example.org