SOPS — THERE’S MORE TO WRITING THEM THAN YOU THINK

“It’s not what you say; it’s what people hear.” - Frank Luntz
 

It is estimated that miscommunication costs the healthcare industry 1.7 billion dollars per year1. Clear communication is critical both personally and professionally, but it’s often harder to achieve than you’d think.
 

One component of Good Manufacturing Practices that aids in effective communication is the creation and usage of SOPs. FDA inspectors want to see that your organization has strong SOPs in place and that employees have been trained to follow them.
 

COMMUNICATION CAN BE DIFFICULT

The creation of SOPs seems simple enough: just write down the correct way to do something. However, communication is not always so easy. In fact, communication is complicated enough that it has its very own discipline.
 

There are a myriad of ways in which communication can go wrong. Unfortunately, management isn’t likely to be made aware that an instruction is lacking in clarity until a mistake is made. That mistake could be costly.

COMMUNICATION MISTAKES

Here are some of the ways SOP communication can go wrong:

Requirements listed as suggestions

Out of politeness, sometimes a requirement is disguised as a request. A supervisor may say to you, “If you have time, I’d like some extra copies.” While most people can read between the lines, sometimes people can take words literally. Are your SOPs written so that there is no question as to what is required?

DIFFERING DEFINITIONS

Many SOP words contain terminology on which people can disagree. Take, for example, the word “clean.” To one person, “clean” may mean visibly free of debris. To another, “clean” may mean sterile.

When writing instructions, it is important to consider the various interpretations others might have.

The pre-existing-knowledge tightrope walk

Writing down an instruction requires a line to be drawn between the knowledge the reader has, and the knowledge the reader does not have. Over-explanations can come across as condescending, or cause the reader to become fatigued and skip sentences. However, too little explanation leaves room for error.

Do you know where to draw the line to make your writing most effective?
 

CULTURAL BACKGROUND DIFFERENCES

Each country has its own communication standards. For example, in some places laws are seen merely as suggestions, and verbal/written communication almost always means something completely different than what was said.
 

Are your documents equally clear to everyone, no matter his or her background?

When it comes to written procedures, it’s good to be proactive rather than reactive. Check out CfPIE’s writing courses to help protect your organization.

CLASSES



Introduction to effective medical writing

Technical Writing for Pharma, Biotech and Med Devices

Writing Effective SOP and Other Process Documents

Medical Writing When English Is Your Second Language
 

1. https://www.rmf.harvard.edu/cbsreport