IS 'COMPLEXITY' AT CRISIS POINT?

Do we focus too much on the paperwork, to the detriment of our medicines and patients?

Reading time: 6 minutes

Summary:

• Has documentation become so complex it’s now a dangerous distraction and your biggest risk? Join the debate
• Why do companies write themselves into noncompliance? All that pain... and no gain!
• Our industry spends $billions on documentation. What do patients get back in return?
• Complexity forces people to take shortcuts. Do you rely on shortcuts (‘custom and practice’) to get product out the gate? Do you falsely assume people are following procedures when they can’t?
• Want to know if your documentation is putting you at risk? Just complete the simple questionnaire below to find out
• So, what next? Is the time for 'common sense and simplicity' long overdue or do we allow documentation to grow and grow. When is enough enough? Take a look at the 'Simplification Road Map'

Setting the Scene:

Three years ago, I met up with a Site Head responsible for 2,300 people manufacturing 5 lifesaving (critical care) medicines.

“Martin, documentation has become more important than the patient. We can’t continue like this. HELP”

 The Site was struggling (any of these sound familiar?)

•  For every person there was 5 SOPs. Yep, they had more paper than people!
• Policies and SOPs had increased by 1,000 % in 3 years BUT headcount had been reduced by 11%. That’s right, less people – more paperwork
• SOP complexity had increased. SOPs had got bigger. Average number of pages? About 34. We did a quick assessment of ‘readability’ (understanding) using a combination of the Gunning Fog and Flesch-Kincaid indexes. Shockingly, 89% were incomprehensible for the target audience. Almost 9/10 SOPs couldn't be understood by users. The site operated on ‘short cuts’. People (and they were all good) were forced to 'work around' SOPs, not follow them. The company had written itself into noncompliance. All pain, no gain. More on this later
• Errors and mistakes (due to procedural non compliance) made up 56% of deviations. What corrective actions were taken? You got it… add even more complexity to the complexity that caused the errors in the first place. More detail, more signatures, more shortcuts, more errors and mistakes
• When we sat down with their finance people the numbers looked bad. We calculated the cost per SOP to be ~ $12,000. So that’s $138,000,000 invested in a system that created pain (risk) for no gain (benefit)
• On top of all of this, the site had to reduce costs by 32% within 2 years

Don’t worry, there’s a happy ending! Three years on:

• SOP numbers - reduced by 38%
• Deviations, errors and mistakes - down 75%
• Productivity is up. Cycle times have improved and they’re making more product faster and rejecting less. Right First Time has improved from 67% to 98% AND staff morale has soared

Are you surviving on ‘shortcuts’ (custom and practice) rather than compliance? The Highlighter (honesty) Test will tell you.

Documentation complexity has reached such levels it’s impossible for most users to follow procedures and complete the task. They can’t do both. But how do you know? Just do the Highlighter (honesty) Test.

• Take one of your most important SOPs and place lots of copies (and highlighter pens) in the coffee room or wherever users relax or socialise
• Place a ‘post box’ in the corner of the room
• Ask them to highlight only what they do in practice, at the workplace; the instructions they actually follow... then post their responses into the sealed box

When we’ve helped companies simplify SOPs, we’ve done this exercise countless times. On average 60-70% of SOP content is not followed. Just try it – but remember one thing, anonymity must be guaranteed.

Documentation Complexity - Your Biggest Risk to Your Patients and Profits?  

Circulate this questionnaire to as many people as possible, particularly document users. Answer each question with either yes or no. It only takes 5 minutes.

1. Are your policy documents kept simple (no more than 3-4 pages) and issued only after consultation/input and adjustment from users?

2. When new regulations arrive do you consult with users before updating your policy guidance?

3. Are users allowed to interpret policy (standards) locally to meet local/regional needs?

4. Have you calculated cost per SOP and the total investment put into your documentation system?

5. Are all SOPs written by the users - for the users - not the regulator?

6. Do you routinely use either the Gunning Fog Index or Flesch-Kincaid to assess user readability/understanding?

7. Do your SOPs have more pictures/schematics than words?

8. Do you test SOP usability in the workplace before implementation?

9. Do you actively prevent CAPAs adding detail to SOPs following a mistake or error?

10. Do you routinely conduct the Highlighter (honesty) Test? 

11. When auditors/consultants/regulators/customers insist on more detail do you challenge or push back rather than just saying yes?

12. Do you make it hard for people to write new SOPs or amend old ones?

13. Do you focus on educating your people, rather than training them? In other words, do you explain the ‘why’, more than the ‘how to do’?

14. Have you banned the ‘read and understand’ approach to training?

15. Are you investing in video/YouTube technology to replace words/paper?

16. Is ‘Simplification’ your companies No 1 priority and do leaders walk the simple talk?

17. Do you use intelligent risk assessment to decide what goes into/stays out of documents. Is your mantra 'less is more'?

18. Do you routinely run Simplification ‘FedEx Days’? (If you’ve never heard of this, answer ‘No’ and give me a call for more information). These are vital if you’re committed to simplification

So, has your documentation become more important than your patient? 

Answered ‘yes’ to most the above? Congratulations – your patients are still No 1.

Lots of No’s? – you could be in trouble.

Some people are outraged when I ask them this question. After all, what sane person would put documentation before patient safety and financial stability?

The point I’m making is this: Complexity = Risk

For every action there is a reaction or unintended consequence(s). Complex documents lead to short cuts and dangerous distraction away from the job that matters. To make consistently good product. 

Getting Back to Basics: The Facts

• We humans don’t deal with complexity well. We were never designed for it. Our prefrontal cortex can only handle 5 facts +/- 2 before we're overwhelmed
• Our average attention span is ~15-18 minutes (and falling)
• When faced with complexity we’re conditioned to look for shortcuts to save energy. Finding the line of least resistance is a hard-wired, survival instinct. Just do the highlighter test if you want proof. Above all, don’t fool yourself that people are following complex procedures, they can’t
• Paradoxically, adding more complexity (doing more and more…) creates a feeling of security and safety when the opposite is true. Less IS more
• The price of medicines is under pressure and profits are falling. Are you being told to reduce costs and do more with less? Have you reached the tipping point – where you simply can’t afford complexity
• What do you do if you need instructions at home? You use ‘You Tube’. Most of us prefer simple, short, video instruction. Certainly not painfully reading complex instructions. Other industries use video so why don’t we? You have a YouTube workforce wired for video, not written instructions
• Remember, Simplification = Agility = Productivity = Survival  

The Happy Ending: Back to Where we Started

How did the site in question turn it around and stay in business? They followed these 5 very hard steps – a simplification road map. Look, adding complexity is easy and requires very little thinking. Simplification is the opposite, it takes brains, blood sweat and tears.  

Your Simplification Road Map:

Step 1: Create the Intrinsic Motivation

Everyone, from the senior leadership team to the shop floor, must be totally committed. Simplification is not a project – it's now a way of life. Without a ‘what’s in it for me’ people will just give up. We spent 3-4 days getting the entire site to understand that simplification = survival.

Step 2: Eating the Elephant One Bite at a Time:

So, with 1,000s of SOPs where do you start? By using Pareto’s Principle (‘The Law of the Vital Few’) which states that 80% of your risk is down to 20% of your SOPs, or there about. By talking to users and looking at quality metrics we identified ~ 800 high risk SOPs. Over many months we boiled this down to 202 using the Highlighter Test.

Step 3. Let the Users Lose – FedEx Days

FedEx guarantee 'delivery in a day'. We assigned each SOP to a smart, dedicated group of 4-5 users and asked them to deliver a drastically simpler version – in a day.

Step 4: Stop Complexity at Source

Preventing complexity is a lot easier than removing it so focus on:

• Ensure the change control system filters out change requests that added complexity
• Redesign the Deviation and CAPA system so it focuses on prevention, not correction. It becomes a Deviation and PACA system!
• Train people on how to conduct simplification audits using our Simplification Tool Kit
• Redesign the SOP system to prevent complexity being added by co-authors. Also agree ‘KISS’ rules (‘Keep It Simple, Stupid’) for SOP design, creation and content to reflect the ‘Simplification Paradox’ which states:

‘The less you tell people, the more they know’

Your Call to Action:

• Do the Highlighter Test
• Circulate the questionnaire – are you at risk?
• Follow the Simplification Road Map.
• Start now - before it’s too late
• Be prepared for blood sweat and tears – simplification is hard work
• Join the debate, share your experiences

Please remember:

Any intelligent fool can make things bigger and more complex... it takes a touch of genius, and lots of courage, to head in the opposite direction

                                                                       Einstein