Why the Way to a Hellish Quality System May Be Paved With Best Practices

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance.

But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get the job done is strong.

Thus “best practices” can actually become a euphemism for cutting corners and taking an apparently easier way out.

True best practices are bespoke — they have to be written to suit your organisation, period. While this may take some time up front, in the long-run, it’s a smarter strategy. Anything else can pave the way to wasted effort, non-compliance, and unsuccessful products.

“Best practices” are infectious

The idea of best practices has been spreading for years, riding on some common business contexts:

  • Expensive Quality Systems consultants: What you might be paying for is the application of the consultant’s standard template — regardless of whether or not the SOPs are actually best for your company.
  • Lightening-fast SOPs from a new QA hire: When QA professionals move from one job to the next, they often bring along “tried and tested” SOPs. This bag of tricks can be a useful shortcut to quickly ramp up and deliver results.
  • Overuse abuse: The term, “best practices” is so overused that it’s essentially meaningless. Who and how can a “best practice” declaration be challenged? Even if you’re able to pass a compliance audit, it doesn’t ensure that your process is efficient in terms of time, resources, or money. Be wary of anyone who tosses around the term “best practices” — there’s a good chance that they may not have a true grip on what your organisation actually needs.

Without your organisation’s real best interests in mind, “best practices” is just a Band-Aid that won’t hold up when your SOPs are put to the test of time.

Common SOPs pitfalls

Before getting into how to be sure you are employing true best practices, let’s do a small reality check:

  • Don’t let the name fool you — SOPs are not standard: It’s rare to have a practice that is “one-size-fits-all.” Best practices depend on the size of the organisation, the regulatory context, the products and the maturity of the quality system.
  • The status quo is wasteful: Using best practices can lead to overly complex procedures. To omit something from a SOP requires more understanding then to add something in. Also, changing the status quo requires courage. This means that “best practices” often obscure options for simplification.
  • Compliance isn’t assured: It would be nice to think that using best practices as a rule of thumb for your SOPs ensures compliance, but the ever-evolving world of regulations combined with the way people tend to cling to outdated practices poke holes in that theory.
How to ensure your SOPs embody best practices

Unfortunately, there is no magic bullet when it comes to Quality Assurance. In a world where resources are scarce, it’s critical to eliminate waste by making your SOPs as simple as possible. The true “best” way to put a quality system in place is to start with the regulatory requirements. From there, implement the most straightforward process possible… and then look for ways to streamline it even further.

Getting your processes right takes an iterative approach of regularly reviewing your system and eliminating steps when possible — which may take years. Still, consistent compliance with a basic process is far better than a complex approach that exists only on paper.

When it comes to quality systems, the best practice you can take is to commit to ever-evolving actions towards compliant, efficient bottom-line results.