The Bad Dream

I’m sitting here on a flight en-route to EWR, and noticed a few birds flying by the window at ~5,000ft…  this got me a bit freaked out and thinking about risk, so here we go! 

As an industry, we must get over this unwarranted fear of risk.  Risk is most often viewed as an unacceptable compliance issue, but in most cases this is simply not true.  I cannot stress this enough.  Processes involving humans performing manual actions will always be high risk, just like the best BBQ will always be in Texas.  No one can argue with those two facts.  Human involvement in our GXP workflows isn’t going anywhere anytime soon, it’s “industry standard”, so we must wake up from our dream-like-state and start to address our collective reality.  Our workflows contain high, medium, and low risk steps, this is the reality - the same as crossing the street or driving a car inherently include various levels of risky hazards.  You will agree with me that ignoring this reality while crossing the street is to your own peril.  The exact same scenario in any given GXP workflow = ignore the reality of risk at your own (and unfortunately the patient’s) peril. 

Management expects the righthand side of the assessment to be “all green”, by whatever means.  This is an unfair expectation – a more realistic management expectation would be to produce the next batch on Mars.  As a result, the assessment team struggles, argues, and ultimately formulates some form of electronic wallpaper to appease management and demonstrate “compliance”.  Layers upon layers of procedural controls are dumped on front-line operations, and unsurprisingly operational deviations are not reduced… and FDA 483s continue to roll-in.  I will [almost] always argue that traditional procedural controls such as additional paperwork achieve the opposite of their intention – and in fact increase risk [and deviations] through distraction and wasted resources. 

I will argue in this blog that when a high-risk step is identified – the only means to reduce this reality is via reducing the “vulnerability” of the hazard [see Annex 11], generally through designing in technical/engineering controls.  This takes time and investment, so in the meantime – focus your energy on employee engagement and empowerment instead.  Additional layers of paperwork are viewed as “micromanagement” by production staff, and crush any cultural momentum.  Don’t go down that path – it’s a dead end.

Check out section 10.2 of the new Annex 11:

“Where a routine work process requires that critical data be transferred from one system to another (e.g. from a laboratory instrument to a LIMS system), this should, where possible, be based on validated interfaces rather than on manual transcriptions. If critical data is transcribed manually, effective measures should be in place to ensure that this does not introduce any risk to data integrity.”

In this case, the regulator is not helping the situation… How can a site demonstrate that manual transcription (vs. a system interface) does not introduce any risk to data integrity? Impossible - so as result the old-habits will resurface. The knee-jerk reaction to this expectation of not introducing “any risk” to data integrity is going to be layers of extra paperwork, witnessing, and distraction.

Consider this instead: controlling risk through mutual respect.  I trust and respect you to do your job so that our products are the best quality at the lowest price.  If you deviate from the standard -that’s OK, bring it up and propose improvements. Management is listening! The reality is that the patient depends on the person to perform the manual transcription correctly (this is a fact), so instead of overcomplicating the process - set them up for success by removing distraction and permitting flow. Additional paperwork is a false sense of security and disrupts flow – again, we need to collectively wake up from this bad dream!

You might as well give it a try, because the status quo [obviously] does not work.  History is an excellent teacher, so let’s start embracing the principles of Lean theory: especially the two main enablers: 1) respect for employees, and 2) continuous improvement.  Start with (1), and (2) will follow organically.  Here is my proposed roadmap:

1)      Wake up from this bad dream,

2)     Eliminate unnecessary procedural layers and focus on flow vs. “all green”,

3) Establish mutual respect between operations and management,

4)     Enjoy the journey.