Thursday, March 26, 2015

4 Reasons Companies Come Under a Consent Decree

When you peel back the layers of causes leading to serious FDA enforcement action, it comes down to a handful of fundamental reasons.

1. Management does not know what is required.

Executive and senior management may not have regulatory experience. MBA programs may offer courses on Quality, but it is more about the popular concepts of Lean Manufacturing, not the Food and Drug Cosmetic Act or the Code of Federal Regulations and CGMPs. Some may go as far as to think that if you are doing Six Sigma, you have a quality program. If you have a quality program, you have the FDA base covered. There is a mental disconnect with CGMPs as legal requirements. It just so happens that CGMPs are also a business enabler that drives reliable processes, product quality, and uninterrupted patient supply. And management must acknowledge and embrace these legal requirements just as much as it does SEC, EPA, EEOC, and other business laws.

2. The Quality Unit lacks the capability to detect problems and report to management.

Management may have regular status updates on how well the market is responding in Europe to a new product launch, or how the new ad campaign is affecting the Southeast Sales Region. But management often flies blind when it comes to knowing at any moment whether the operation is in a state-of-control. That knowledge is thought to come with regulatory inspections. You deal with the FDA483 when it comes, and that buys you time until the next inspection. The Quality unit often buys-in to this reactive mode of problem detection since this is when resources are most likely to be justified. The Quality Unit must develop the systems and the capability to detect unacceptable trends and be empowered to report problems directly to management. Such a mindset is essential to move from a reactive to an anticipating organizational culture.

3. The organization cannot plan and execute permanent solutions.

It’s one thing to know about a problem and something entirely different to do something about it. The best position to be in prior to a regulatory inspection is to be able to say, “There’s nothing you will find that we don’t already know about. Not only do we have a plan to address these problem, but also our plan is on schedule.” But all too often projects to prevent failure move to the bottom of the priority list for resources. If they do get funded, the projects are not directed toward a permanent solution, or managed to a verifiable conclusion. Not only must compliance projects must be resourced and managed, they also require oversight and governance to ensure that the projects are supported and completed on time.

4. Lack of integrity.

Then we have the phenomenon of doing whatever it takes for self-preservation over the health and welfare of the patients we serve. No degree of knowledge of the requirements or the presence of highly effective detection and escalation systems can prevent dishonest individuals from violating public trust. What we can do is have a zero-tolerance Integrity Policy that is part of every employee’s training curriculum, and to make it safe for someone to voice his or her concern should they witness a violation. In addition, training on Good Documentation practices will help to standardize record entries and how to document correction of errors. This will counter the perception of fraud for honest mistakes. The dishonest ones—well, that’s another matter.

Opinion Survey:  Reasons Companies Come Under Consent Decrees

When the FDA starts moving against your company is not the time for introspection. Take this quick survey and use the results in an internally facilitated discussion. Now is the best time.

How would you rate your company? What are the implications for your collective results? Most of all—take action.

5 = Strongly Agree
4 = Agree
3 = Not sure
2 = Disagree
1 = Strongly Disagree

_____ a. Our management demonstrates visible support for CGMP projects to ensure our compliance position is strong.

_____ b. Our Quality Unit has robust processes that provide management the means to know the state-of-control and to take decisive action.

_____ c. We have a good history of directing teams toward potential compliance problems and finishing on time.

_____ d. We have an Integrity Policy and everyone knows how to confidentially report a potential violation.

John E. Snyder
The QA Pharm

The QA Pharm is a publication of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.

Contact us at

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