Factors that can slow down time to market: Regulatory Compliance

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You’re in the middle of the project and some requirements come up related with regulatory compliance that you weren’t aware of. But what is regulatory compliance?

“Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.(1) Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls.(2) This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources.”(1)

If your project needs to comply with certain regulations it's possible that compliance reports and milestones may have been omitted as requirements. You may slow down time to market if you need to add them later on.

 Depending on the industry, different regulatory bodies govern these activities. Industries include, among others, the following:

  • Financial

  • Aviation

  • Pharmaceutical

  • Food Industry

  • Safety

  • Internal Compliance

Let me briefly touch on examples of these.

Financial

If the project you’re managing is in the Financial Industry there may be some regulatory compliance associated with it.  An example of a regulatory compliance in the financial sector may be SEC disclosure requirements for reports generated by a system being developed through your project.  Make sure a Subject Matter Expert (SME) regarding the financial industry is available when putting together the requirements and estimating the work.

Aviation

If the Federal Aviation Administration (FAA) governs part of your business you should know that they have very specific Management Information System (MIS) Report specifications for companies with employees performing safety-sensitive functions. Examine these specs well to introduce them as part of the requirements and design of your project.

Pharmaceutical

“The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation.” (3)

Take into account all pertinent regulations to your project. If your project deals with Medical devices, your FDA SME should be aware of what to report, the reporting forms, the recipient and the time interval.  As an example, deaths, serious injuries and malfunctions should use Form FDA 3500A, should be reported to the FDA and it should be reported within 30 calendar days of becoming aware of an event.  All detailed specification should be defined at the onset of the project to avoid delays in your project.

Food Industry

Projects in the food industry may be dealing with a variety of topics such as GMO reporting, food traceability, restaurant standard operating procedures, etc. All these topics are governed in many instances by regulatory compliance. Do your research to make sure your taking this into account in the planning stage.

Safety

 If the project you’re managing involves operations & safety, the Occupational Safety and Health Administration (OSHA) may have standards that you may need to incorporate.

These standards vary and depend on your industry, they may include topics such as Blood borne Pathogens, Hazard Communication, Respiratory Protection, Occupational Noise Exposure, Powered Industrial Trucks, Hazardous Waste Operations and Emergency Response, Personal Protective Equipment and many others (4).

Consider bringing an OSHA expert to help with requirements and design if you think they apply to your project.

Internal Compliance

Lastly the organization may have internal regulatory compliance rules. Any project should take these into account.

In my next blog I will touch on other factors that may slow down time to market.

Tchau!

Diego Ferrer, PMP

 

References

  1. Compliance, Technology, and Modern Finance, 11 Journal of Corporate, Financial & Commercial Law 159 (2016)

  2. Jump up ^ Silveira, P., Rodriguez, C., Birukou, A., Casati, F., Daniel, F., D'Andrea, V., Worledge & C., Zouhair, T. (2012), Aiding Compliance Governance in Service-Based Business Processes, IGI Global, pp. 524–548

  3. FDA Fundamentals. https://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm

  4. Occupational Safety and Health Administration. Regulations (Standards - 29 CFR) https://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=1&p_keyvalue=1910

 

Posted on: March 20, 2017 05:44 PM | Permalink

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