2. KEEP YOUR QUALITY PRIORITIES RIGHT AND MAKE THEM CLEAR
Toyota example: Toyota's CEO admitted that the company began to put efficiency above quality.
"I would like to point out here that Toyota's priority has traditionally been the following: first, safety; second, quality;
and third, volume," said Toyoda. "These priorities became confused...we pursued growth over the speed at which we were able
to develop our people and our organization..."3
These statements suggest that the understanding of priorities and how to implement them was uneven within the organization.
Lesson for Pharma: The goals of the company—in the form of its mission statement, quality policy, and priorities—must be communicated to and
understood by all employees. Proof of effective communication is the ability of each employee to paraphrase the goals of the
company in his or her own words if asked.
3. THE CORPORATE CULTURE OF QUALITY MUST EXTEND WORLDWIDE
Toyota example: Toyota's much-vaunted corporate culture of quality was not exported to manufacturing sites around the world. The challenges
of rapid growth and international marketing contributed to the lack of uniform worldwide quality.
Lesson for Pharma: The quality management systems described in the FDA's Quality System Regulation (21 CFR 820), ISO 9001 (Quality Management System), and ISO 13485 (Quality Management System for Medical Devices) are broadly overlapping
in their requirements and are applicable across international borders. Regulatory authorities do not recognize rapid growth
as an excuse for non-compliance. The take-home lesson is: Do not grow faster than the establishment of quality systems permit.
Furthermore, the corporation's quality responsibilities are not limited to work performed within the corporation; they extend
to vendors and contract manufacturers. Therefore, vendor audits and the use of approved vendor lists are critical for success.
4. PAY PROPER ATTENTION TO COMPLAINTS
Toyota example: Toyota is alleged to have ignored or minimized thousands of early reports of sudden acceleration in its vehicles.4
Lesson for Pharma: Every complaint must be recorded and analyzed, and any complaint that involves a product specification must be investigated.
Accumulating data must be analyzed for trends and preventive action must be taken to prevent a problem from getting worse.
There is a misconception in the pharmaceutical industry that some threshold number of complaints must be received before there
is need for a recall. Not so. Even one valid complaint can trigger a recall. If the complaint is credible, serious, and unexpected
(i.e., it does not appear in the product label), it would behoove the firm to immediately investigate, sending a technical
person to the site of the complaint if necessary.
In a real life example, my quality control laboratory received a high assay on an antimicrobic raw material and a complaint
was called in to the pharmaceutical company client. The next day, there were two technical representatives from the pharmaceutical
company at my door—even though my laboratory was 1,200 miles away! They took the complaint seriously because a valid high
assay would have a serious adverse effect on patients. As it turned out, the discrepancy in assays was attributed to a difference
in testing methodologies, demonstrating the important QC lesson that you cannot separate laboratory results from the methodology