How to say goodbye to Regulatory Compliance headaches

how to maintain optimal use of qms with suppliers

Just when you thought it was safe to go back to your office. All seems in hand and everyone’s happy and aware of what needs to be done. But then those bad dreams start again. Rules, rules and more rules, right? 

While they are there for our own good we cannot seem to escape them. As we all have been taught, facing our fears head on is the only way to go, and compliance issues are no different. Failure to meet regulatory conditions and guidelines could mean fines and penalties, not to mention loss of face. It gives me a headache just thinking about it. The main source of pain is that organizations today have so many areas of compliance, with multiple regulations abound. Sure it seems like a sticky web, and it is, but that doesn’t mean you need to get caught up in it, awaiting your fate as an auditors midnight snack.

So how do you go about getting rid of the merciless dreams and potential pain all this obligation may induce? Having a plan; a realist’s view of compliance and then partnering with real solutions provider, is the first step.

Overcome Threats

Organizations today are confronted with risks of all kinds. Whether its document control, or protecting sensitive data, the key word is identify. The challenge is to find, isolate then work towards mitigating and hopefully chasing them away. In order to put a plan of action into place, it is essential that any organization understands where its weaknesses may be. Maybe it’s an intrinsic human nature thing to baulk at it, but compliance is about preventing the unforeseeable, a kind of shark net along your organization’s borders. From then it continues in a teaching capacity by allowing us to study those which threaten and thereby gain valuable intelligence. It is this intelligence that allows us to sleep at night.

Synchronicity and Harmony

Sounds a bit like puppies, love and rainbows, doesn’t it, but the fact is that there is a continuous need for operational transparency. The late 1990’s and 2000’s ushered in an overabundance of new laws governing privacy, accountability and security, and many companies now look for the perfect solution. It was recognized fairly quickly that what we needed were the tools to allow us to achieve this. Many turned to information technology as their salvation. So what can good software solutions do? A common framework that works with both risk and compliance is ultimate pain reliever. The right software should see these two things as strangely connected bedfellows, and be the mediator when the friendship renders the occasional argument.

One tool, or a cohesive family of software tools, is what we need to make not only our lives easier, but our employees in their duties and obligations, whether directly involved in compliance or not. As a word of caution though, what we are looking to do is avoid the use of multiple and disparate compliance tools. These only succeed in duplicating and complicating processes and documentation. They also create an environment of confusion and of risk and compliance profiles not conducive to best practices. As an example, when looking for ISO family compliance, ensure your tool complies with the requirements of all industry-specific and generic ISO standards for Quality, Health, Environmental & Safety management systems: ISO 9001, ISO 17025, ISO 14001, ISO 22000, OHSAS 18000 and more if available. Is FDA & GxP compliance your bag? Make certain your software solutions can assist you comply with both 21 CFR Part 11 (FDA) and GxP requirements. And by the way: Standard validation templates are a real winner to help you move along the path of implementation smoothly.

Slaying the Dragon

As the number of compliance potential bombshells have increased since the turn of the century, fit for purpose staff are seen as the first step to taming the beast.

If you don’t currently have a Compliance Officer or similar, give serious consideration to getting one, and fast. This person’s sole focus is and should be to ensure your organization is conforming to sometimes complex legal mandates. Organizations are now expected to navigate around what could be a volatile minefield of staff requirements, including personnel resources, and while they may add costs, the price of not having this type of specialist can be significantly higher. Remember, the long arm of the compliance police reaches far.

Have a plan. Be mindful, proactive and think about all of the above and more, when it comes to being prepared. For with preparation comes confidence.

See it as an aspirin for the inevitable compliance headache.

Take two and call me in the morning.

You are in good company