FDA, EPA, OSHA, MOC, CC, PSM, SOP ... HUH?

Operating guidelines for the manufacturing industries

Every manufacturing industry has a certain set of guidelines under which it must operate. For some, that may mean strict document control, for others it may mean proper waste containment strategies. Either way, there are several agencies that regulate manufacturing industries. The ultimate goal is to protect the patient and customer at the end of the manufacturing process, as well as the human lives that work tirelessly day in and day out to deliver the product.

The FDA and the Pharmaceutical and Medical Device Industries

For example, in the pharmaceutical and medical device industries, the FDA (Food & Drug Administration) plays a pivotal role in ensuring that the drugs, therapeutics and devices that are made for human consumption and use meet the highest standards. After all, this is something we're actually putting inside our bodies. Think pill. Think pacemaker.?

All manufacturing at a pharmaceutical or medical device facility is performed with the patient in mind.

Pill manufacturing at a pharmaceutical plant

Medical devices play an integral part in how hospitals and medical offices provide care to their patients.

The EPA and the Chemicals Industry

In the chemicals industries, it is the EPA (Environmental Protection Agency) that plays a critical role in manufacturing. In that case, the EPA helps ensure that chemical plant emissions are kept to a minimum.

Any discharge from a chemical plant must be contained and treated before being discharged. That even includes rain water runoff. If it touches the surface of the plant, it has to be treated first.?

Many of the products we use today start their lives at a chemical plant manufacturing facility

Safety First with OSHA

In my experience, I've seen that OSHA (Occupational Safety & Health Administration) plays a huge role in both the chemicals and pharmaceuticals industries. OSHA's mission is to ensure the human lives that keep the plant running 24/7 go home in the same condition as when they walked in.?

OSHA's scope ranges from equipment guarding on rotary pumps to working at height requirements and everything in between.?

Safety First!!!

Staying ready for audits

In order to remain in compliance with these agencies, manufacturing industries invest in large amounts of documentation. These industries need to remain in a state of readiness for an audit. An auditor can drop in at a moments notice. You don't want to be caught off guard when an auditor, probably trained by the FBI (yes, really!) walks through your doors.?

Auditors are trained to ask questions, lots of them.?

You had better have all your ducks, goats, sheep and giraffes in a row. Maintaining adequate documentation is key to ensuring your audit goes smoothly. Now is not the time for surprises.?

Auditors go over every inch of your facility with a microscope and a small-toothed comb.

Is your change control process audit-ready?

Documentation typically under scrutiny is the MOC (Management of Change), also known as CC (Change Control). The MOC is the formal process under which a change to the process is documented. This is critical and can be ripe for errors. Every time you change a part of the process, you need to think through how that change can impact the overall safety and quality of the process.?

In the chemicals industry, the MOC process typically falls under PSM, Process Safety Management.?

PSM is the large umbrella under which all things chemical safety are managed at a chemical plant.?

Other items that fall under PSM include SOPs (Standard Operating Procedures). SOPs need to be clear, concise and expertly guide the reader through the necessary tasks.?

The need for effective documentation

At times, it can feel like you're managing an alphabet soup of regulations. Not another agency? Not another acronym, right? However, effective documentation that is managed well can make this process so much easier. Investing in the time upfront to create documentation systems that essentially maintain themselves and encourage healthy documentation practices (here's to initialing and dating everything, Big Pharma!), will save you headaches in the future.?

What are the pressing documentation needs for your manufacturing facility have?

When is your next audit?

How can I help ensure your facility stays in compliance with your particular "letters of the alphabet"?

Connect with me today at WordsbySimone.com to partner on your journey to effective documentation across all your departments.

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