The Quality Secret

Because he’s that good (oh yes), I’m bringing back one of my favorites . . . McCormick LifeScience Consultant LLC’s most brilliant (Mark, don’t let this go to your head) consultants, Mark Goodsell, a Quality professional with over 20 years GXP experience.

Take it away Mark . . .

In a scene from the baseball movie, Bull Durham, catcher Crash Davis (played by Kevin Costner) gets mad at his pitcher, nicknamed “Nuke” (played by Tim Robbins), because the future superstar insists on throwing a fastball to the imposing batter, when Crash is calling for the curveball. Crash finally gives in, but not before telling the batter the next pitch will be fastball. Needless to say, the batter hits a tremendous homerun and Crash admits to tipping off the opponent after a stunned Nuke says, “It’s like he knew what the pitch would be.”

32So what does this have to do with the pharmaceutical industry? Well, since the calendar tells us it is spring (and it’s starting to actually feel like it!), I thought a good baseball analogy was in order. For some reason, this movie scene came to mind while joining a fellow QA professional for an after work beverage. He had just returned from a vendor facility audit and told me that he had a fairly positive impression of the company, however, the audit host actually tipped him off about some specific compliance issues. Unbeknownst to management at most companies, this is a fairly common practice when Quality Management becomes frustrated at the inability to get the proper resources to address compliance problems.

Charged by the FDA with the job of maintaining GMP compliance within an organization, the Quality Assurance Unit (QAU) between companies is sort of a quiet brotherhood. When a QAU is unsuccessful in getting a satisfactory response from management on specific compliance issues, they take a page from Crash Davis and enlist the help of willing auditors to get their point across to management. The exchange can be subtle, such as willingly giving the auditor non-compliant documents for review, or the audit host not defending a company practice. It can also be as bold as just flat out stating a problem to the auditor. As a fellow quality professional, an auditor is more than happy to help out and ensure the issue is discussed during the close out meeting with management and subsequently placed into the audit report.

Unfortunately, the QAU is often seen as being restrictive and overbearing. OK, I will admit that in some cases this can be true, but in a broad sense, it is the responsibility of the unit to keep a company out of trouble by putting the proper systems and controls around each process so that business continues to operate within regulatory requirements. When it comes to quality systems, there should be strong communication between the QAU and Management that ensures issues are addressed prior to becoming critical problems that can hinder effective business.

Effective companies have the following procedures in place that ensure compliance issues are dealt with at the highest level of management:

  • Regularly scheduled (annual, semi-annual, quarterly) senior management reviews of company quality systems.
  • Mechanisms for documenting the meeting and putting together some type of corrective action plan.
  • A feedback plan that reviews the effectiveness of any corrective actions.

Finally, if you are at a facility and run into Crash Davis, you know you have someone who is always working with the best interest of the organization in mind.

Toto's Tips

  • Quality is a company-wide mind set, not something just handled by the Quality Unit.
  • Active participation by senior management is crucial in building effective quality systems.
  • All companies should strive for an environment of continual improvement.
  • Feedback mechanisms are necessary for all systems and should be evaluated on a regular basis.