The Justice Department’s revised Evaluation of Corporate Compliance Program Guidance (“DOJ Guidance”) was released with little fanfare.  It is difficult to find the press release that accompanied the release.  No one at DOJ flagged the issue in advance of the release.  No speech or event accompanied the release.  All was relatively quiet from the DOJ front. Do not be fooled by the relative silence of...

The Department of Justice quietly issued revisions to its Corporate Compliance Program Guidance.  DOJ’s revisions underscore important new trends in corporate compliance — the importance of resources and empowerment, continuous monitoring, proactive strategies, access to and use of data, consistent discipline and new, training strategies. In this episode, Michael Volkov reviews DOJ’s changes to its Corporate Compliance Guidance and puts the changes in perspective to...

DOJ is catching up to compliance officers and evolving best practices.  Say what you want, DOJ is behind the curve of the compliance industry.  But you have to give DOJ credit – they are moving quickly to update its Guidance.  Compliance is a fast-moving profession – innovation and technology continue to define the industry.  Compliance officers are willing to embrace change and the industry is...

If anyone thought that DOJ was planning to relax its expectations regarding corporate compliance programs, forget it – DOJ has removed all doubt.  In an announcement on Monday, June 1, 2020, DOJ released revised guidance, Evaluation of Corporate Compliance Programs, June 2020. DOJ issued the new guidance to reflect its own experiences and feedback from the compliance and business community.  According to Assistant Attorney General...

The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in anticipation of developing a new vaccine, treatment products and testing.  As a result, pharmaceutical, medical device and diagnostic and laboratory tests will be subject to federal scrutiny and monitoring for proper use...

Paul Kruse, former CEO of Blue Bell Ice Cream, was recently charged with criminal charges stemming from the sale of contaminated ice cream, resulting in the death of three persons.  Kruse was aware of serious safety and contamination issues arising from the production of Blue Bell ice cream.  Notwithstanding his knowledge, Kruse ignored safety concerns and withheld critical information from its customers and consumers. In...

Boeing is still under investigation.  A grand jury is investigating potential safety and obstructions allegations.  Congressional investigations are continuing.  Civil litigation surrounding the 737 Max are continuing.  Boeing’s long path out of this nightmare appears to be rocky and filled with continuing risks, financial harm and reputational risks.  In reviewing the wreckage surrounding Boeing’s culture and safety performance, public disclosure of over 100 pages of...

Boeing’s 737 Max problems began over ten years ago.  Facing competitive pressure from Airbus, Boeing embraced the 737 Max as its competitive savior.  After two horrific crashes killing a total of 346 people, the FAA ordered the grounding of the 737 Max. Despite the grounding, Boeing produced another 400 737 Max airplanes before ceasing all manufacturing of the airplane in January 2020. The two plane...

When a company suffers from serious misconduct, the source of such a failure usually lies in its corporate culture.  I know this theory sounds relatively obvious, but bear with me here. The CEO and senior management and the corporate board are responsible for creating, oversight and monitoring of a company’s culture. Corporate boards and senior management work together, communicate regularly and should set an example. ...

NAVEX Global produces a number of valuable compliance reports.  Aside from its annual Third-Party Risk Management Report, NAVEX Global’s Hotline and Incident Report is always valuable given its leadership role in the hotline and incident management industry. The NAVEX Global Report is based on 2019 data before the pandemic occurred. Nonetheless, the insights are helpful and provide important insights that can be applied in a...