What the Pharmaceutical Industry Can Learn From Toyota's Recalls - Twelve lessons of what to do and what not to do to avoid quality problems. - BioPharm International

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What the Pharmaceutical Industry Can Learn From Toyota's Recalls
Twelve lessons of what to do and what not to do to avoid quality problems.


BioPharm International
Volume 23, Issue 7

5. SERIOUS ADVERSE EVENT REPORTING MUST BE HANDLED WITH DILIGENCE

Toyota example: At the time of this writing, 39 deaths have been attributed to runaway Toyotas.5

Lesson for Pharma: The FDA has specific regulations to handle serious adverse drug experiences on marketed products. In the case of pharmaceutical or biological products, the recipient of a serious and unexpected adverse drug experience has 15 calendar days to report it to the FDA.6 The industry faces its greatest challenge to meet the reporting deadline because international adverse event reporting sometimes is delayed by time and holiday differences. Strict adherence to allotted review times and adequate global adverse event handling systems are essential.

6. CONDUCT A THOROUGH SITUATION ANALYSIS BEFORE MAKING PUBLIC STATEMENTS

Toyota example: During its handling of the recalls, Toyota's managers made inconsistent and sometimes contradictory statements, suggesting that they had not analyzed the situation carefully before they began speaking about it.

Lesson for Pharma: When a major problem begins to surface, a situation analysis should be prepared to pull together all of the information and analyses for management review and action. The company's conclusions must be supported with a well-thought-out rationale that will avoid inconsistent statements. Don't get caught like a deer in the headlights, unable to respond effectively and demonstrate as clear an understanding of the problem as available data permits.

7. PERSIST UNTIL YOU IDENTIFY THE ROOT CAUSE OF THE PROBLEM

Toyota example: Toyota defined the problem (unexpected acceleration, faulty braking) and then investigated, but may not have gotten to the root cause. Problems were blamed on faulty floor mats and sticky gas pedals; however, there have been reports that the problem continued after the "fix," which suggests that the root cause may not have been identified.7

Lesson for Pharma: Promptly define the problem, investigate, and get to root cause by performing a root cause analysis (RCA). If you do not get to the root cause, there cannot be an effective corrective or preventive action (CAPA).

8. WHEN ADDRESSING A PROBLEM, INCLUDE ALL AFFECTED PRODUCTS

Toyota example: Toyota knew about those problems years ago and made some fixes on models sold in Japan, but delayed addressing the problems on other cars.8

Lesson for Pharma: Effective CAPA includes addressing all other products that may be affected. For example, if one drug or one model of medical device is judged to have a deficiency, all of the drugs in that class or all medical devices in the same family must be examined as part of the investigation.


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