In the June Issue of Innovative Thinking, we wrote about "Reducng Redundancies". In this July issue, we address Regulatory Mandates, one of the most critical challenges for many of our clients and growing companies in the Process Industries.
Don't miss our What's new section this month. Introducing our new BLOGS and our new monthly WORD SCRAMBLE feature.
Regulatory Mandates - Can You Keep Up? By Paul Sita, Ph.D, President, Innovative IT Consulting, LLC. Paul can be reached at 631-549-1685 or email@example.com.
Regulated or Strangled? The industries we serve are highly regulated industries.
A variety of governmental and regulatory agencies develop standards and requirements that are intended to protect the public, provide peace of mind and ensure a level playing field in terms of product consistency, quality and continuity. This includes bodies such as the EPA, OSHA, FDA, and mandates such as the Bioterrorism Act, Sarbanes-Oxley, HAACP (Hazard Analysis and Critical Control Point) CFR21 part 11 governing electronic signatures, and C-TPAT (Customs Trade Partnership Against Terrorism).
A Dual Edged Sword. Many regulatory mandates are a double edged sword whereby compliance can be promoted as a marketing differentiator, similar to ISO certification. However, others are like the proverbial hammer, representing a deadline that can’t be moved with penalties that are swift and severe.
You don't have to suffer the stranglehold of meeting regulatory mandates. IT is part of the solution, not part of the problem!
In almost all cases, the solution involves IT: Capturing highly detailed information across the entire supply chain, and linking that information in a highly predictable and secure way with audit controls so that the information can be relied upon to be accurate and having the tools in place to produce information on demand – this is not a simple challenge!!!
It should be no surprise that regulatory ranks 2nd only to overall information access as the driver to replace legacy systems.
Legacy Systems add to the chokehold. Legacy systems simply do not have the breadth or depth of information nor the flexibility to produce information on demand. Gone are the days when it was good enough to produce an MSDS on demand. Companies are now conducting mock-recalls and preparing highly sophisticated monitoring systems to ensure and demonstrate readiness and compliance.
Failure is not an option. The stakes are high – not just from the specific penalties that can be assessed. The PR cost of comtamination, failure to notify or the perception of being a laggard in terms of compliance can be a setback from which it is difficult to recover.
Follow these techniques for success. What to do? If you are in a regulated industry here’s some best practices to follow:
- Do establish a focal point for regulatory within your organization.
- Don’t assume that regulatory only affects one department – it doesn’t. It affects every aspect of your operation. (See this month’s TIP on regulatory).
- Do attend trade conferences and listen to vendor’s webinars to educate yourself.
- Do speak with others in your industry
- Don’t assume that your system “can probably” meet regulatory compliance. Develop regulatory scenarios and practice them regularly.
- Conduct an assessment of your regulatory capabilities to determine your actual level of compliance vs. your perceived level of compliance. The gap can be startling.
- Conduct a realistic assessment of your Information Technology capabilities. Partner with solution providers who understand the issues.
Act now and continuously. Much like implementing an ERP system the key to meeting regulatory mandates is a combination of the right tools, and a continuous, organized and focused effort.
This isn’t your father’s Regulatory Department anymore.
By John Pellegrino, Principal, Innovative IT Consulting, LLC. John can be reached at 631-549-1685 or firstname.lastname@example.org.
Much like the Oldsmobile, things have changed drastically since your parents were working with regulatory agencies within their respective places of employment. With the unfortunate events of 2001 the changes have become more frequent and more restrictive. What does this mean to a company looking to change or enhance the use of their enterprise wide computer system?
Where exactly is the Regulatory Department? When you look at your business processes you find that the Regulatory department is part of many processes and shows up multiple times within each process. Simply put it permeates all business processes at various “touch points”. It does not work outside of the business processes, but is an integral part of each process. See the main article in this newsletter for more detail.
How do you make sure that the Regulatory needs are met in your enterprise system:
- Recognize that it is not to be treated as an afterthought and is to be handled as an integral and vital part of your organization
- Make sure Regulatory is represented in your cross functional team (see last month’s tip for some ideas on this team)
- Depending on your size and the amount of regulation in your industry, dedicate people to understanding and complying with the regulations.
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Word Scramble. This month we’re introducing “Word Scramble” a new feature in our monthly newsletter.
“Standards, approaches or methodologies for successful system implementations”.
- - - - / - - - - - - - - - (2 words) T E R P S I A B T C C S E
Hint: The answer phrase is mentioned in our main article. (Answer next month)
In the August issue, we'll help you answer the question "Are you getting everything you should out of your ERP System?"
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