Quality experts know that SOP training has positive effects on a company’s performance and success. Yet senior executives can resist even a minimum amount of training, especially when they do not operate daily in a GxP environment. These executives can lack an understanding of how minimal training for all employees can maximize efficiency and better protect a company from exposure.

Quality has a responsibility to educate and answer the “why” and the “how” of this training before new systems are implemented. One way is to educate non-GxP staff about FDA violations, where they come from, and how they are discovered. Many violations center on the failure to have, properly use, or adequately train employees on SOPs. Inadequate SOP training observed by the FDA in one functional area can indicate a broader problem.

When talking to the C-Suite, Quality must demonstrate a cause-and-effect relationship between Quality and financial results. The Bottom Line: seemingly small violations can lead to significant downtime and lost revenue or worse – risk to patient safety or non-approval.

When properly designed, minimal SOP training provides all employees—not just those working in GxP environments—with practical, understandable information that enables safe and efficient job performance. The key is to demonstrate long-term gain with a short-term focus on training on “Fundamental Five” SOPs. This training for all employees will be central to a business’s success, saving time and money in the long run.

The “Fundamental Five” SOPs include:

1) Good Documentation Practices

This training defines acceptable practices for completion of quality records, applicable to Quality Management Systems across a company. This can have an impact on many employees. As an item called out in a 483, improper documentation can be a small sign of a larger problem and may lead investigators or auditors to suspect—and search for—larger issues. This training is required to properly complete a training form, which is a GMP document that can be part of an audit and is usually one of the first items to be inspected.

2) Training Program

Describing how training is conducted and documented at your company decreases your exposure. Period.

To ensure compliance, it is necessary to demonstrate that your company is training employees on their specific roles and responsibilities, expectations, and the criteria to assess when and how to conduct training. These items create consistent practices on all types of training—from new hires to GxP training. This training is required to understand your responsibilities with respect to training and to properly document training. And again, this documentation can be one of the first items to be requested by an inspector or auditor.

3) Inspection Readiness

This SOP training prepares employees to be in the same room as FDA investigators who are there to question and interview. Regardless of how skilled, and well-meaning your people are, they can slip up and cause unnecessary concern.

Any investigator can draw conclusions from what your employees say, do not say, or from the way they do or do not say it. The best way to ensure that inspectors take a positive view of your business is to prepare your staff. Train them so they are confident and comfortable with being put “on the spot.”

4) Electronic Signature Record, Agreement and Delegation

This training addresses how to capture employees’ signatures to trace any document signature back to an employee. It also outlines how to delegate signing authority. Training on such procedures is a basic requirement for all personnel, including temporary and contract associates working in a GxP regulated function or participating in regulated activities that have signature authority for GxP documentation.

This training also reviews the creation of documentation for a preapproval inspection or a client audit. It also allows people to choose appropriate people to delegate signing authority should they be unavailable. Once again, you want approved documentation that denotes who has signing authority.

The implication of such training? Your signature has power and is legally binding. It is the first thing you learn in Day One of GMP training. You are accountable for it, and for people to whom you choose to delegate signing power.

5) Customer Complaints and Employee Responsibilities: Reporting Serious Adverse Events (SAE) (as applicable)

The Complaints SOP rounds out the “Fundamental Five” with Employee Responsibilities: Reporting Serious Adverse Events being an optional sixth depending on the company. If you are a sponsor company (pharmaceutical, biologics, device, etc.) performing clinical studies, everyone within the company needs to be trained on the Employee Responsibilities: Reporting of SAEs SOP because at any given time any employee of the company may have be the recipient of information regarding a SAE and is obligated to report it. Knowing how to do so is why this is an important SOP on which to be trained.

Every company is required to have a Complaints SOP. Similar to the Employee Responsibilities: Reporting SAEs SOP, training on this SOP ensures every employee knows the process for reporting or escalating a complaint if they receive one. This training helps employees identify, assess and manage any complaint and provides a level of preparedness that helps companies to deal with and resolve issues efficiently. People know what is expected of them, what they must do and who they must inform.

“Fundamental Five” SOP Training can influence a company’s performance and success. When talking to the C-Suite, Quality must provide background to demonstrate the cause-and-effect relationship between training and company performance both from a patient safety perspective and a financial one. Everything influences the bottom line when (not if) issues arise. Training is one of the areas where FDA inspectors and auditors will suspect, and search for, larger issues should they find smaller ones.

This type of SOP training is like a fire extinguisher. Nobody wants to be bothered to learn how to use one …

But what is the first thing they should look for—and rely on—once a fire starts?