Do you teach learners how to handle errors?

With Terry McGinn

Training programs usually teach “the right way” to do something, supplying learners with perfect answers, procedures, methods, policies, information, and so on. That’s good, but as you probably have noticed in your operations or studies every day, it isn’t enough. How often have you heard an employee implementing a “work around” that makes you want to smack your palm to your forehead after all the routing and requested changes (e.g. “You did WHAT in a sterile area?”)

The right way to do things works as long as everything goes according to plan. As we have all learned, nothing always goes according to plan. Every once in a while, you’ll encounter a deviation (and that’s okay). And when you do, what you do is critical. It can be the difference between averting a disaster and creating an issue that won’t pass regulatory scrutiny.

So, while the average training program teaches employees how to do it the right way, a full education teaches your employees how to do it right way and gives them the capacity to think through things that don’t go as planned. Comprehensive SOP training teaches investigational processes as well as correct document procedures to ensure the quality standards for your products are met and the results are recorded for investigational purposes, when necessary. After all, teaching requires building competencies.

But do we teach people how to take the right actions, make better decisions, choose wisely, and handle deviations? Most of the time, the answer is no. The severe impact of mishandled opportunities to make good, independent decisions can result in slow, no or poor actions, errors in judgment, and impulsive or risky decisions. And any of those things can hit your organization’s bottom line or reputation in fines, product recalls, regulatory rejection and more.

Interested in hearing more? Join us for a one-hour primer on applying critical thinking skills in an SOP environment and find out:

• Why you need to teach learners more than just the “right ways of doing things”
• Why workers and learners need to learn beyond the “what” to the “why”?
• What are Critical Thinking Skills and how do adult learners absorb information?
• Why do Critical Thinkers always learn new things while at work?
• How is Critical Thinking applied in errors or unfamiliar situations?
• How can we set up a culture of Critical Thinkers?

Join us for our free webinar “The Process of Critical Thinking About Your Standard Operating Procedures” and learn how to apply critical thinking skills in SOP situations.

Click on this link to register for the webinar hosted by Levy & Levy Enterprises with your presenters Terry McGinn and Peggy Salvatore on Friday, May 18 at 10 a.m. Eastern. And bring your questions. We look forward to meeting you there.

Photo by chuttersnap on Unsplash

3 Tips for Creating Transparent SOPs

Co-written with Terry McGinn

Each company in a regulated industry is required to follow written procedures.  The written procedure describes how steps or tasks are to be followed to achieve the desired outcome or result.  Having these steps identified permits the distant or precise way to achieve the end of your process or practice. 

Knowing the critical nature of having written procedures, your standard operating procedures and best practices need to follow a few procedures of their own so you can replicate what you do across your organization.  In other words, your standard operating procedures need to be transparent and streamlined.

One of the many purposes of the SOP or best practice process is to ensure that the process flow can meet expectations. Done well, your standard process or procedure should result in a quality product or achieve the desired result every time.

Knowledgeable and trained  personnel must have the SOP available to follow because no matter how many years’ experience they may have, even experts get stuck for a variety of factors. In fact, some experts know their jobs so well that they think they can skip or modify steps, take shortcuts, or do it from memory. This is a red flag!

The SOP should be written in a logical process flow that will allow someone looking for the cause of a failure later can pinpoint where  a difficulty arose. Reviewing the SOP with someone internally or externally who is checking or auditing your procedure should allow them to identify what and where things  went wrong.

When you have a point of failure, an examination of the SOP should indicate gaps or problems that can include one or more of a host of issues including materials, equipment, environment and much more. Often, a failure can point to the source of your complications by reading the SOP against practice.

A well-written procedure or best practice document will:

1. Be written to describe the flow clearly to anyone trained on it
2. Include every essential step without including extraneous steps or materials that can and should be accessed elsewhere
3. Always be followed by everyone from the new hire to the veteran employee using the current SOP

Expect you will have changes to your SOPs on occasion. Expect you will need to review your documents periodically according to your SOP. And expect that when you have a clean, clear, streamlined SOP process that your errors should be few and easily identifiable.

To summarize, standard operating procedures and best practices need to follow procedures of their own so you can replicate what you do across your organization.  In other words, they need to be transparent. If they are the opposite of transparent – opaque – they are hard to follow and may result  in errors.

If you would like to talk to us about your SOP process, give us a call for a no-obligation preliminary review of your procedures.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation about writing your standard operating procedures, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash

By Terry McGinn and Peggy Salvatore

We’ve been getting quite a bit of interest and feedback regarding our series on standard operating procedures, so we’ll continue writing about this topic this week.

After all, inherent in the word “expert” is the idea that something is done correctly. Correct procedures and best practices need to be captured and passed on. Sometimes, though, it seems the only people who care if the SOPs are followed are the experts who wrote them.

Truth is, everyone needs to care. Accountability right down to the last man or woman is absolutely the key essential ingredient in ensuring regulatory compliance.

Train for Accountability

Employees who are tasked with executing the many small, incremental steps are responsible only for their piece of the process. Sometimes in the laser-focus on one task, people may lose sight of the bigger picture. That bigger picture – a safe product going out the door – needs to be reinforced occasionally. Training usually steps in here for both reinforcement and correction. When that fails, the regulatory authorities will notice. Companies get slapped with government warnings and fines at a higher rate than the average person may realize. But if you are in a regulated industry, you know how often you are out of compliance.

Think about dialing the failure point back to its origin. The failure point is when the SOP is not correctly written, understood and applied.

Only then does the employee fail to perform to specifications.

Only then will training have to step in for often very expensive correction.

Only that will happen when an audit reveals you are out of compliance with your SOPs, and the Corrective and Preventative Actions (CAPAs) applied at that point of failure. That doesn’t need to happen.

In a perfect world, it should look like this:

If your current plant is not operating flawlessly as above, identify your points of failure:

1. How many people are asked to retrain personnel after a deviation or equipment issue?
2. How many SOPs do you have? Are they overwhelming or conflicting?
3. Are they easy to understand and do they follow a logical, stepwise process?
4. After a deviation, is the SOP reviewed?
5. Are people observing the CAPAs?

And, the big question…

Do your employees feel responsible and accountable for performing their jobs according to the SOPs in place?

Employees feel empowered when they are able to follow well-written SOPs, and when they are acknowledged for contributing to a well-run organization. Points of failure cannot be business as usual. Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

Maybe that is worth repeating:

Organizations that accept points of failure as the status quo have a company culture that unintentionally encourages non-compliance.

And the road to audit hell is paved with regulatory non-compliance.

The Solution

Dial back your points of process failure to the source.

Ask yourself:

• Are my SOPs well written?
• Do my employees feel a sense of responsibility for performing to specifications?

If your answer to either of those questions is, “No” or “I don’t know”, give us a call.

We would be happy to speak with you.

Unlike some problems in the universe, the problem of poorly-written and executed SOPs can be solved. Let’s do it.

Terry McGinn has worked in regulated industry for many years and has experience in written procedures that will help pass scrutiny of a regulatory authority inspection. To have a conversation, write to us at workingwithsmes@gmail.com to set up an appointment.  

Photo by Drew Hays on Unsplash