Fatal Flaw: Cover Up or Snowballing Worth It?

By Regulatory Doctor (LinkedIn; Google Plus; Twitter)

I am a regulatory and quality professional working in the healthcare industry. We, healthcare professionals, seem to consider (patient) safety mattters as the top priority.

I am puzzled by the News that appeared in New York Times on June 6, 2014, entitled "G.M. Lawyers Hid Fatal Flaw, From Critics and One Another."

The news states:

An internal investigation released on Thursday into the company’s failure to recall millions of defective small cars found no evidence of a cover-up. But interviews with victims, their lawyers and current and former G.M. employees, as well as evidence in the report itself, paint a more complete picture: The automaker’s legal department took actions that obscured the deadly flaw, both inside and outside the company.

Legal professionals (lawyers) should have known, and had reasons to know better that "what(ever) goes around, comes around." Why would they hide fatal flaw when they became aware or informed of fatal flaw? It is so easy to cover up quality matters, but to keep the facts secret permanently is literally impossible - it is a matter of time.

In healthcare industry, there are cases that the firms ignore quality matters (e.g., fatal flaw or defects) even over the threshold leading to serious injury or death and have chosen to retaliate against those who have brought serious quality issues to the management.

It is recommended that the quality problems be addressed as soon as they appear or are brought to the management's attention. Otherwise, firms are likely to be on the risk of beginning to willfully, knowingly, recklessly, and/or negligently cover up or snowball quality problems, which will only gradually become worse and can lead to catastrophic consequences.

Treat Critics As If You Are Opening a Present: Thank Them and Express Appreciation to Them

When a firm encounters any complaint of quality matters brought to the attention of anyone or the management, it should be welcomed. The firm should carefully assess and fairly investigate completely and in full.

Take a Prompt, Adequate Corrective Action in an Effective Manner

Firms must identify all complaints and evaluate them and then investigate serious ones. Based on the outcome of a fair investigation (not based on hearsay or "sham" efforts), an adequate corrective action shall be taken, which will fundamentally address the problems (e.g., eliminating the actual root cause(s), so that the same or similar problems do not recur).

"PASS-IT" Recommendation or Suggestion: No Cover Up or Snowballing

Industry should hear all complaints and address each and every one of them. Although some professionals may defend that we have reasonably dealt with all complaints as part of business operation. However, when we repeatedly observe serious quality problems over and over, it can't be concluded that a corrective action taken was adequate.

Please be aware that any retaliatory action, instead of taking an adequate corrective action, including ignoring the problems, will be more likely than not to eventually cause or contribute to snowballing the problems only waiting to get worse and worst to all the parties involved.

The safety of our patients or consumers should be protected and any gambling for the safety matters should be avoided at all cost - no cover up or snowballing of quality problems!

About Me with Regulatory Doctor and Global Compliance Seminar

I, David Lim, Ph.D., RAC, ASQ-CQA, am President and Principal of REGULATORY DOCTOR. I frequently present global laws, regulations, rules and guidance applicable to medical products. In particular, I provide seminars on various global and FDA compliance, highly focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, I have developed 510(k) templates ready for immediate use compliant with e-Copy and RTA policy. I also have developed the industry’s first 510(k) and PMA drafting seminar series delivered online, intending to help global regulatory affairs professionals become a 510(k) or PMA pro. In addition, I have been providing FDA inspection checklists for drug and device manufacturers based on my analysis of FDA inspectional observations cited in 483s for the past seven years. I provide my feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during FDA’s transparency public meeting in 2009. I recently authored the Chapter 22 Postmarket Requirements in the Book entitled “Fundamentals of Global Regulatory Affairs, ” published by the Regulatory Affairs Professional Society (RAPS). I am an author for the RAPS’ online class for EU medical device regulations. I lead and direct all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the REGULATORY DOCTOR.