Imagining Knowledge in the Age of AI

K35621_cvr  Artificial intelligence, data, analytics, neural net, computer-human interface…these aren’t the future. They are now. For those of us with a foot in the age of human intelligence and a foot in the age of artificial intelligence, it makes us wonder: so what do we make of what we know, if we (as humans) may become irrelevant?

It’s not as ridiculous as it sounds.

This blog will be brief because the idea is huge, and I want to give us all time and space to ponder this one thought.

Humans are finite, at least for now. We have a limited lifespan. For generosity’s sake, let’s call it 100 years. And then we take what we know with us when we go.

Some of us have preserved our thoughts, ideas and creativity for future generations, but let me venture to guess that most of us have not.

For millennia, without that knowledge capture, preservation and transfer, we kept starting all over.

All that changed with the printing press, and accelerated rapidly with video and audio capture. Look at the rapid proliferation of knowledge, now doubling about every one or two years because we are able to continue to build on what came before.

So what is the threat of AI to human intelligence? Here it is…

Computers don’t die. Teach them to think, and they will keep thinking and growing and learning and eventually…well, their intelligence surpasses that of any human simply because their learning curve is theoretically infinite.

This is what all the fuss is about.

I leave you with that.

And encourage your thoughts and debate in the comment section or send an email at workingwithsmes@gmail.com.

Oh, by the way, my latest book, Retaining Expert Knoweldge: What to Keep in an Age of Information Overload, was published in hard cover on May 10 and you can buy it here. I just noticed that a Kindle version has been added. Thank you for your continued interest!

 

Available Now! Retaining Expert Knowledge: What to Keep in an Age of Information Overload

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I couldn’t wait to get out the word that my new book, the latest in the Working with Experts series, is available for sale today!

I’ll be doing some promotions which you will hear about later, but for now here’s the description on Amazon:
Retaining Expert Knowledge: What to keep in an age of information overload covers two major topics central to capturing and transferring expertise in organizations:

  • Methodology and best practices for interviewing subject matter experts (SMEs) to capture their knowledge
  • Identifying the SMEs to interview

The more critical problem is identifying the SMEs and the knowledge that needs to be captured.

One reason identifying the right experts is now so important is that in the next 10 years, the largest recorded exit of talented and knowledgeable workers from organizations will occur as baby boomers retire. In their wake, they leave their former employers understaffed and, even scarier, under-informed. Identifying the right SMEs is also critical because of the rapid acquisition of new knowledge. Some estimates say knowledge now doubles every two years, so it is crucial each organization identifies its journey and catalogues it individually and collectively.

This book provides managers with answers to the following questions:

  • Are we talking to the right subject matter experts?
  • What knowledge should we capture?
  • What knowledge needs to be captured immediately as opposed to eventually?
  • If we have limited resources, which experts are most important to speak with first?

Every organization has a history, a culture, and knowledge that may have lost its current relevance but not its importance. It is that broader vision of capturing knowledge, which this book addresses. It guides readers on how to preserve corporate knowledge and provides tools to assess organizational circumstances and judge the value of the resources to capture.

Retaining Expert Knowledge is a training resource, but it is also a business resource. As knowledge proliferates and organizational culture rapidly changes, now is the time to step back and determine what has been important to your organization’s success, where the organization is today, and what it will take to stay in the game tomorrow.

Your company houses knowledge, skills, attitudes, intellectual property, trade secrets, company culture, and individuals who will never be replicated exactly as they are today. Because they have demonstrated value in the past and are demonstrating value today, these treasures are worth preserving. This book shows how to preserve these valuable assets today for tomorrow’s successes.
You can buy this wherever you normally purchase your books.

Here’s a link directly to Amazon. 

 

Free Webinar 5/18:Critical Thinking Skills and Your SOPs

chuttersnap-425090-unsplash  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

Working with Retiree-Experts and an Encounter with a Growing Business Niche

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Experts who know home construction or music production are not usually experts in how to package and sell their services. So when they are facing retirement – whether or not by choice – the desire to continue to serve often burns within them. If you are that retiring expert, how do you offer your services outside the structure that your old job provided?

A 2013 survey by AARP showed that 23.6% of new businesses were started by entrepreneurs 55 to 64 years of age expecting another 15 to 20 productive years. I have personally worked with several vital octogenarians in the past few years who were still actively contributing while taking steps – such as writing books and building training programs – to preserve their legacy.

Some retiring experts find a way to offer their services ad hoc to friends and former colleagues. But others get more deliberate about creating a business of their own. In fact, retiring experts have created a boon in a niche market teaching business skills to people trying their hand at entrepreneurship in their second career. Experts retiring from one field seek other experts who know modern marketing, sales and revenue-generating techniques to handle the business details for them. Last week, I attended a conference of about 200 experts – many of whom were building retiree or second-life businesses – sponsored by a company based in Montreal that teaches experts how to handle the business end for themselves.

Combining Expertise and Business Acumen

Often, successful enterprises are based on the subject matter expertise of person and the business acumen of another, and that combination can make a big difference in the world.

Think Steve Jobs and Steve Wozniak. We know one name so well and the other…not so much. Jobs and Wozniak are the dream team responsible for the first personal computer and the company that came to be Apple. Jobs knew computers but he really understood business, marketing and his customer. Their dynamic pairing demonstrates that many great businesses are built on an expert who joins forces with an entrepreneur who can envision the possibilities.

The experts at the Montreal conference each paid close to $20,000 for business support over the next 12 months from this team of business building experts. Obviously, this company found a lucrative niche by filling in that business knowledge gap helping experts to monetize the value of their specialty, and for both parties I imagine it is a good deal.

Not all experts want or need to monetize their expertise commercially. Sometimes the satisfaction of passing on your hard-earned knowledge in front of a college class or in journal articles is more than enough reward.

But for experts who are looking to build a business on a lifetime of knowledge, there are people building businesses to help you. AARP can’t be wrong. With nearly a quarter of new businesses started by entrepreneurs of retirement age, any expert with a passion can live the entrepreneurial dream in the second half of life.

Perhaps we can start a club: E. R. A. Experts of Retirement Age.

Are you in a corporation losing its expertise to retirement? Your expert may thrive in retirement. Let me help you review your knowledge management plan so your company can thrive after they leave, too. Contact us at workingwithsmes@gmail.com

 

Photo by Raul Varzar on Unsplash

 

 

In an Age of Over-Regulation, Are Compliance & Safety Mutually Exclusive?

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In going through my old blog files, I found this item from another website where I was writing about five years ago and thought it particularly relevant for our SOP, compliance and regulation series. So without further ado, this blog asks the question: In an age of over-regulation, are compliance and safety mutually exclusive?

In aviation, safety is always the primary concern. In fact, aviation’s safety record is so stellar that it is considered a model for healthcare. That is quite a testament.

However, a retired pilot friend recently bemoaned that the emphasis on FAA rules and regulations has overtaken concern about safety, and aviation is not better for the change.

“Now we’re only concerned about compliance. We have a cast of thousands as support staff. When I started flying in 1964, Part 91 federal regulations were about 30 pages. You could memorize it. Today, it is hundreds, if not thousands, of pages and nobody can possibly know everything that is in there. We are less safe today than we were 50 years ago,” he complained.

Making and keeping track of all those regulations costs aviation a lot of money. It requires a boatload of federal regulators to oversee them, and costs private carriers a bundle of money to hire people to monitor every jot and tittle of the laws. One misstep, and they can shut you down. And, he opined, neither the passengers nor the airline employees benefit from this over-regulation.

Will Healthcare Follow Aviation Again?

Just about everyone in healthcare knows about the vaunted aviation checklist, and how it has become standard procedure in many operating rooms today. Books are written and consultants make good livings just teaching the checklist approach to safety. The checklist is a great tool. Healthcare is better for following aviation down that path.

But is healthcare going to benefit by following the FAA down the road to over-regulation? We can trip on our path toward safety by using regulations as stumbling blocks instead of using some common sense rules to pave a smooth road to improved quality and performance.

So Many Rules They Can’t Be Followed

I recall a conversation from a training class at a major pharmaceutical company. We were training hourly line employees on procedures that affect product safety. To a person, they had one complaint: standard operating procedures were becoming downright cumbersome and made it very difficult to follow, let alone implement, them.

One veteran employee said when an incident occurs, someone writes another procedure and adds it to the book of procedures. Nothing else in the book is deleted or changed, and so it is becoming nearly impossible to follow. In fact, the employee complained that SOPs are written in response to each incident, meaning that many new SOPs only relate to one isolated incident each. The SOPs are losing their meaning and rationale. It is just a jumble of unrelated knee jerk reactions to specific incidents.

The employee concluded the company was creating more problems than it was solving by having a procedure manual that could not be followed. There are now so many rules to follow, the rules can no longer be followed, the employee complained.

Is All of Healthcare Headed Toward Unwieldy SOPs?

With the passage of the Accountable Care Act, known colloquially as ObamaCare, many believe that we are headed down a path of over-regulation. Where common sense and good medical practice once dominated the industry, healthcare practitioners (formerly known as nurses and doctors) are overwhelmed with rules regarding how they practice, to which the actual art and science of medicine is taking a backseat.

At a recent visit accompanying a friend to a physician’s appointment at a hospital center, we observed that we were two of only four people sitting in a new waiting room with 25 chairs, two large receptionist desks – one that seated four and another with 12 stations – and a physician accompanied by a nurse and a receptionist carrying around a brochure rack deciding where to place it. Let me say that again. A highly skilled specialist was carrying around a brochure rack with his nurse and receptionist trying to find a place for it.

In this brand-spanking-new hospital wing where our doctor’s office had been moved since our last visit (from a very modern, extremely functional office building now sitting vacant in the parking lot), we also observed not one – but two – printers behind the one receptionist desk and a wall of file drawers. We filled out our medical information on a clipboard, which we have done for each of his visits for the last three years, to have it inserted into his manila file folder.

Sigh.

The Trend Is…

By personal experience as well as professional observation, the trend is toward more regulation, more staff to assure compliance with the rules, and an ongoing steady stream of physical and electronic paperwork to track patients and processes in all sectors of the industry.

Instead of continuing to ramp up our regulatory oversight into the stratosphere, perhaps it is time to – if I can paraphrase my retired pilot friend – throttle back and re-evaluate what we are really trying to accomplish.

Photo by NeONBRAND on Unsplash

 

Falsification of Data: Truth or Consequences

justthefacts  By Peggy Salvatore and Terry McGinn

Sometimes expert knowledge isn’t really knowledge at all. In fact, if your data sounds too good to be true, it just might be.  Sadly, for reasons of human sloth, greed or carelessness, sometimes the experts who supply your data are giving you bad information – and they know it.

In Finding Your SMEs, we discuss times when you may be dealing with conflicting expertise or when you may be asked to ignore some information and favor other information in your documentation to please a stakeholder. In those cases, you aren’t dealing in bad data. Rather, you are dealing with differences of opinion.

That’s an honest debate of the relevant facts.

Falsifying data to purposefully mislead someone is different than simple disagreement among experts.

When you are dealing with falsified data, there are no facts. There is no honest debate. There is only an intent to deceive. In regulated industries that depend on quality data to remain in legal compliance, falsified data can have many bad outcomes including products that are substandard, dangerous or deadly. Your best defense is to know your regulations and how to work with them because, remember, you can be guilty simply by omissions.

Remember Volkswagen? What About Your Drugs?

In 2015, the U.S. Environmental Protection Agency discovered that many VW cars were outfitted with software programmed to falsify data during emissions testing showing the cars met carbon dioxide emission standards. The brand suffered substantial damage and the company was exposed to up to $18 billion in fines when it was discovered the cars actually emitted up to 40 times the allowable amount. This attempt to defraud the public resulted in massive car recalls and a loss of company credibility along with profits.

Money lost. Reputation lost. Environment damaged.

In biopharmaceuticals, clinical trial data is the stuff upon which the Food and Drug Administration makes decisions about the safety and efficacy of pharmaceutical products. Does data get falsified there, too? Unfortunately, yes!

A 2001 study showed that falsification of scientific data used in FDA evaluations of experimental drugs was not uncommon, and it ranged from falsifying the identities of clinical trial subjects and their physical exam results to creating duplicate records to achieve the desired number of trial subjects.

It still happens today.

Just a few weeks ago, a Kyoto University research group headed by Nobel laureate Shinya Yamanaka was found guilty of fabricating all six main data figures in a study published in Stem Cell Reports. The study claimed it had modelled the blood-brain barrier in vitro using pluripotent stem (iPS) cells. Yamanaka, who won the 2012 Nobel Prize in physiology or medicine for discovering iPS cells, reportedly was going to donate his salary to the university as a mea culpa but the damage to his reputation will live beyond his paycheck.

Bad data can hurt – or even kill- patients and it exposes the biopharma research companies who rely on quality data to potentially billions of dollars in fines and, at the end of the day, the delay or loss of up to a billion dollars in research and development for a product that can’t be supported by strong, reliable data sets.

Is Your Data Subject to Tampering?

One of the ways to ensure that your data is valid is to have strong processes in place for data collection and auditing. Long before an FDA or compliance inspector finds a problem with your product or process, you can lock down your documentation with well-written and faithfully executed standard operating procedures.

By taking some strong action today, you can implement steps to avoid harm to your brand reputation, delayed or denied product approval, heavy fines, jail time and, of course, harm to patients.

If you would like to discuss your process for developing and implementing standard operating procedures, write to us at workingwithsmes@gmail.com and schedule a no-obligation appointment for a review of your organization’s data integrity vulnerabilities.

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.

Extrovert or Expert? 5 Ways to Give Quiet Experts a Voice in Your Business

thTWTQH724   Sometimes, this is true. So, how can you help quiet people share their ideas?

Bias is part of the human experience. We are biased in our choices of people, places, things, and thoughts. Often, those biases are just harmless shortcuts to making everyday decisions based on experience or personal preference. In business, those biases can short-circuit logical decision making.

But they don’t have to.

From “Why Our Brains Fall for False Expertise, and How to Stop It,” author Khalil Smith tells us that often it is the tallest, loudest, or the boss’s pet who gets the attention in a meeting and therefore holds the decision-making power. Those biases tend to lead to sub-optimal decisions.

Smith, who heads the diversity and inclusion practice at the NeuroLeadership Institute, wrote last week in Strategy+Business that “biases are human- a function of our brains – and falling for them doesn’t make us malicious. [However,] with the right systems, tools and awareness in place, we can better cultivate the best ideas from the most well-suited minds.”

Here are a few ways to avoid the pitfalls of natural human bias:

  1. Set up “if-then” plans. If the dominant and most charismatic person’s ideas are being adopted in a meeting, then set up some space between the discussion and the decision by adjourning and polling others for their input. Their impressions might reframe the decision.
  2. Get explicit, and get it in writing. Write out the process by which you came to a decision. “We decided X, which led us to conclude Y, which is why we are going with Z.” You can revisit this document later to evaluate what worked and what didn’t.
  3. Incentivize awareness. Encourage employees who detect flaws and celebrate the “mistake of the month.” Error detection helps de-stigmatize a situation and provides learning opportunities that lead to better decisions next time.
  4. Set up buffers. Create a cooling off period between the time you receive information and the time you make a big decision. You might have time for a 10 minute walk or -better yet – for reconvening the next day to discuss issues that may have been overlooked.
  5. Cut the cues. Find a process that removes the person from the idea. When you are brainstorming, have people submit ideas anonymously so the strength of the idea, rather than the status of the person, can be evaluated on its own merit.

Personality may win the day in many cases, and it can be appropriate at those times. Expertise, however, cannot be easily replaced and should not be ignored when you are making the big decisions for your business. With a few simple moves, you can make sure the short and quiet people get their ideas in front of you, too.

To read this strategy+business article in full, click here.

Back by Popular Demand: More on Writing Standard Operating Procedures

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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

The Difference Between Thought Leaders and Subject Matter Experts

rita-morais-108397-unsplash  A colleague who read my book Working with SMEs approached me and posed the question, “What is the difference between a thought leader and a subject matter expert?”

She didn’t ask the question as a challenge, and I don’t think she expected an answer on the spot. She asked it in an exploratory way. We looked for a moment at each other, and I said I would think about it. I knew there was more to the distinction than an easy definition of each term. For the last two months, I’ve been thinking about it.

Another colleague recently said she is sick of the term “thought leader” and thinks it has become overused and meaningless. I agree that the term and concept is in vogue, but after much consideration, it is not meaningless. If someone is known as a thought leader, they are someone who has earned recognition for their opinion because their experience gives them a catbird seat on a particular issue. The term “thought leader” is only meaningless if someone refers to themselves that way.

I liken “thought leader” to the term “sensei” because it is not an honor you can bestow upon yourself. When I studied Lean, I encountered a man who referred to himself as a sensei or “wise one”. Other Lean practitioners took me aside to explain that he had committed a faux pas because one does not refer to oneself as a sensei. It is presumptuous. Other people may refer to you as a sensei, but you may never call yourself one. In that way, just because someone calls themselves a “thought leader” does not make it so.

Thought Leaders Have Perspective and Vision

A thought leader is someone who has perspective due to their vast and deep experience in an area. They are sought by others to share their opinions with the group to help others gain perspective. Because of their perspective, thought leaders also have vision. They can usually see around corners into the future. Due to their perspective and often (but not always!) deep experience, a thought leader can make an educated guess about the direction events will take. A true thought leader earned it through years of deep thought about an  issue, and sometimes after years of making mistakes, too, giving them vaunted vision about the way things could be .

Thought leaders usually have some sort of platform. It could be within their organization, industry or profession. It may be a broader platform like the New York Times where a columnist can inform and influence millions of people. The visibility of a platform like the New York Times will catapult someone into thought leadership.

Thought leaders are exactly that – they have thought about things a long time, have opinions that are valuable and valid based on their background, and are willing to be out in front of the crowd leading others in a certain direction.

Last year, I spent four days attending a live, online seminar by author, speaker and trainer Brendon Burchard called the Thought Leader Roadmap. I wanted to see what he had to say about thought leadership. He is of the opinion that you can either be a thought leader by experience or you can become one by studying an issue in depth and then speaking out about it from a position of knowledge after repackaging what you’ve learned from reading and interviewing experts.

Which neatly leads us to the difference between thought leaders and experts.

Experts Have Deep Knowledge about a Subject

Some academicians have actually come up with a literal definition of a subject matter expert. An expert is someone who has studied a topic for about 10,000 hours or at least five years. Many true experts in complex topics like physics and biochemistry become experts only after 20 years or more of diligently working in the field. However, their subject matter expertise does not necessarily make them a thought leader. Some of the world’s greatest SMEs are unknown people toiling in the corner of a lab somewhere. They aren’t leading anything or anyone. However, they may be blazing trails in science or technology that very few people will ever know about, except that your smartphone knows where you are, your Internet connection gets more reliable every year, and cancer is now considered a chronic disease in some circles.

A SME is not always the brilliant biochemist in the corner lab, though. A SME in your organization is someone who knows something very well after years of being in your company. You have subject matter experts who know your business deeply and possibly even irreplaceably in accounting, sales, engineering, manufacturing and administration. They aren’t thought leaders. Most people don’t know what these quiet SMEs are thinking or even know who they are. And for the purpose of being a SME in their corner of the world, the concept of thought leadership is irrelevant.

Some SMEs are thought leaders, but being a SME does not make you a thought leader. Most, but not all, thought leaders are SMEs.  However, if you are a thought leader in your field either because you put yourself out there as one or other people turn to you as one, you will eventually need to develop deep and broad expertise. If you are a thought leader and not an advanced expert, your thought leadership will have limited value. Yes, some people are always behind you and those people will regard you as a leader. Others who are true SMEs look to thought leaders who have the same or greater level of expertise, so the farther ahead you are in your field the more people by sheer numbers are behind you.

A thought leader who is a SME with deep and broad knowledge is suited to lead many. A thought leader who is developing their expertise but willing to step out front will lead fewer. Both will have impact but one will have much greater influence on the future because they are speaking into many lives.

How would you define a thought leader? Who do you know who you would consider a thought leader?

Standard Operating Procedures and Accountability: Perfect Together

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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:

Point of Success

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