Regulatory Affairs

Paralysed by Complexity? Solutions that Work

Published 17 January 2017 | By NSF International

Over-complexity is the silent killer for many companies, and it’s a proven fact. The largest 200 companies in the Global Fortune 500 listing lose approximately 10.2% of shareholder value every year due to complexity

What is the complexity that is causing so many headaches for so many otherwise-robust companies?

Here is an example of a recent NSF client who was at the mercy of over-complexity:

Following a tough GMP inspection NSF were called in. The company's long and expensive Form 483 from FDA included all the usual "failure to follow SOPs", "repeat deviations", "multiple documentation errors", and lots more. Following the company's internal review, the site director provided a list of root causes and their even bigger, more expensive list of Corrective and Preventive Actions (CAPAs).He asked NSF what we thought, and our response:

"These CAPAs will only make the situation worse because you've missed the single biggest cause of each and every regulatory criticism - OVER-COMPLEXITY."

Late-stage pharmaceutical development requires complicated, expensive processes that do not allow much freedom. Other sources of complexity arise in companies that have grown large as the result of mergers or acquisitions.

There are numerous symptoms of over-complexity, of which many are overlooked. In order to implement successful solutions, it is first of all necessary to identify and determine which symptoms your company is suffering from, these questions do just that:

Symptom No 1: Are you Risk Averse?

Symptom No 2: Do you really understand your products and processes?

Symptom No 3: Do you have complex bureaucracies and hierarchies?

Symptom No 4: Do you have a 'Corporate Rules' culture?

Symptom No 5: Do you have unworkable SOPs and documentation?

Symptom No 6: Do you spend lots of time firefighting?

Symptom No 7: Does your Change Control system approve everything?

Symptom No 8: BAD consultants!

President of NSF Health Sciences, Martin Lush, provides further detail surrounding potential symptoms and solutions on his LinkedIn post, 'Paralysed by Complexity - Some Simple Solutions'. This has proved to be a hugely successful article, utilizing Martin's extensive experience within the Pharma industry.

Some Solutions: How You Can Simplify

Simplification is hard work, requiring total dedication to clarity, honesty, discipline and intelligence. Here at NSF we have created, and utilize, a six- step simplification process that works:

  1. First, create an open and blame free culture. Without transparency you can't simplify.
  2. Use small groups of smart people and move fast. Don't give people too much time to overthink (it only complicates!)
  3. Identify the core purpose of the SOP or system being simplified
  4. Process map (visualize) reality and how people interpret it. Make it simple to understand
  5. Remove anything that doesn't contribute to the core purpose. Use risk assessment
  6. Protect what you've simplified. Don't let people put back in what you've taken out

Your Call to Action

Our customized simplification workshops are not just simple, they are effective. And they are necessary. Over-complexity takes many forms, and simplification efforts can make profound impacts. NSF has helped clients achieve dramatic results:

  • Batch Records reduced from 371 pages to just 56 improving 'right first time' to 99%. Savings generated = £1.3 million
  • SOPs reduced by 70% reducing non compliances and human error by 67%. Savings generated? £890,000
  • Deviation management system simplified, resulting in a 76% reduction in repeat deviations

You don't really have a choice - Simplify or suffer!

Remember, complexity leads to:

  • More time needed when you have less available
  • More cost you can no longer afford
  • More energy wasted
  • Greater risk
  • Demotivation and disengagement

And finally, make sense and simplify your mantra. Simplicity is an exact medium between too little and too much. That's your goal.

Want to Know More?

NSF's human error prevention services provide practical tools and techniques to help reduce so-called human error and repeat deviations, which can save significant costs and protect companies from severe regulatory action. The following links provide invaluable help and are all free!

'The Art and Science of Simplification. Winning your war on complexity'

'How to educate using the 10/20/70 approach'

'How to achieve a blame free culture'

'Paralysed by Complexity', a LinkedIn post written by Martin Lush that received 1,000 readers in two weeks. Find out why here.

Want to know more about our Simplification Workshops? Just contact martinlush@nsf.org

Make use of our extensive library of free resources including our in-demand webinars here.

For more information about NSF Health Sciences Pharma Biotech Consulting' services, please call us on + 44 (0) 1751 432 999, email pharmamail@nsf.org or visit our website.