Quality professionals 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 don’t operate daily in a regulated environment. Executives can lack an understanding of how minimal training for all employees can maximize efficiency and better protect a company from exposure.

This article will discuss:

• Six SOPs that every person in a company should be trained on and why. These SOPs are:
  1. Good Documentation Practices
  2. Training Program
  3. Regulatory Inspection Readiness
  4. Electronic Signature Record, Agreement and Delegation
  5. Customer Complaints
  6. Employee Responsibilities: Reporting Adverse Events (AE) (as applicable)

• Why train on these six SOPs.

• How to begin the process to set up your SOP training for success.

Quality has a responsibility to educate and answer the “why” and the “how” of this training. 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 senior leaders, Quality must demonstrate a cause-and-effect relationship between Quality and financial results. The Bottom Line: seemingly small violations can lead to significant downtime,  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 the “Fundamental Six” SOPs. This training for all employees will be central to a business’s success, saving time and money in the long run.

The “Fundamental 6” 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 inspectors 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 periodic 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 inspectors 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 inspector 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 client audit. It also allows for the appropriate assignment and delegation of signing authority should people 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 on Day One of GMP training. You are accountable for it and for people to whom you choose to delegate signing power.

5. Customer Complaints
Every company in the clinic is required to have a Complaints SOP. This procedure 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.

6. Employee Responsibilities: Reporting Adverse Events (AE) (as applicable)
This one rounds out the “Fundamental 6” if you are a sponsor company (pharmaceutical, biologics, device, etc.) performing clinical studies. Everyone within the company needs to be trained on this process because at any given time, any employee of the company may be the recipient of information regarding an AE—and they are obligated to report it. Knowing how to do so is why this is an important SOP on which to be trained.

How to Craft a Well-Written SOP

The best way to train on SOPs is to begin with crafting well-written ones that provide clear instructions for easy accessibility to the end-user. Here is advice to keep in mind:

• Before writing an SOP, gather those involved in the process first.
  Engage all of the people potentially designated as having a role in the process. It provides all parties ownership and easily identifies owners of a process. This is the time to identify gaps— rather than when an incident occurs. By bringing stakeholders to the table to participate in the crafting of the procedure, it can positively impact training, communication, expectations, and culture.

• Write in a concise, step-by-step, easy-to-read format.
  Write what is done and in the order it is to be completed. Keep sentences brief and use simple common terms.  You don’t get extra points for using flowery language.

• Write the main point immediately, using the active voice and action verbs.
  Such verbs include approve, direct, assign, designate, evaluate, review, revise, or identify. Use the active voice with present tense verbs. One of the authors of a 2019 University of Toronto study, Sam Maglio said, “while using passive voice may seem more objective, and preferred by those communicating about science, it can also seem more abstract by losing a sense of immediacy.  … If you want your audience to get revved up, you may need the sense of immediacy and closeness that comes with the active voice.” The passive voice can suggest “special connotations in addition to the basic message,” which can blur overall meaning.

• Avoid ambiguous terms (e.g., periodically, generally, typically, may, and should).
  These terms indicate a preference and do not enforce consistent execution, a vital part of SOPs. Avoid terms such as “SOPs are reviewed periodically to verify the current process.” Say when they should be reviewed as in “SOPs are reviewed annually to verify the current process.”

• Use terms may, must, and should appropriately.
  • May allows for flexibility. No deviation if it is not adhered to (“Based on the risk and criticality of the study, the auditor may conduct more than one critical phase audit.”).
  • Must indicates a step that must be adhered to. (You must file a deviation if it is not adhered to (“The initiator must provide a justification for the extension as well as a new proposed expiry date.”).
  • Should indicates execution of the process is determined by a conditional clause. A deviation is required if appropriate conditional requirements are not adhered to (“If timelines are not met, the initiator should request an extension.”). Always describe the condition first and then the action to take if that condition applies.

• Use lists and bullets appropriately. Bullet lists are effective because they quickly focus the reader’s attention on key elements they need to remember. They give readers an opportunity to stop, slow down, and process critical information. The white space they create also provides a break between long, visually intimidating paragraphs.

Here are best practices to keep in mind when developing SOPs that provide clear instruction that help to avoid deviations and maintain compliance. Remember that an SOP is:

• A set of step-by-step instructions used to perform a specific routine operation.

• Purpose-driven to ensure that people carry out the operations correctly and always in the same manner so there is efficiency, quality output, and uniformity of performance.

• Meant to clearly outline who does what, when, and how to reduce miscommunication.

• Also meant to have procedures written from the perspective of end users.

This development process yields clear, concise SOPs with well-defined roles and responsibilities. In this fashion, SOPs can be easily implemented and followed. This can result in greater compliance and reduction of time, effort, and resources spent on investigation, deviations, and CAPA documentation.

“Fundamental Six” SOP Training can influence a company’s performance and success. When talking to the senior leaders, Quality must provide context 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.

SOP development and training can be thought of like a fire extinguisher. While no one wants to bother to learn how to use one, it is the first thing they look for—and rely on—to keep a fire from spreading out of control.

About the Author
Judy Carmody, PhD is the founder and Principal Consultant of Carmody Quality Solutions, LLC, a quality solutions provider to life science startups and global Fortune 500 organizations who are passionate about keeping patients safe and delivering quality products. Dr. Carmody has 25+ years of expertise in driving vision in quality and operations. She is the former founder and president of Avatar Pharmaceutical Services, an FDA-registered contract research organization and manufacturer which was acquired by Vertex Pharmaceuticals in 2010.

Affiliations:
Member, Society of Quality Assurance (SQA); New England Regional Chapter Society of Quality Assurance (NERCSQA); Association of GXP Excellence (AGXPE); and Women in Bio

[Published in Volume 40.1 of Quality Matters, Quality Spotlight Article]