2020

CAREER CORNER

Blank-Slate State

QA managers should focus on basics and simplification

by Denise Wrestler

When organizations are faced with creating a quality management system (QMS) from scratch, or completely overhauling a pre-existing one, you may find yourself hired on as the experienced quality assurance (QA) master tasked with installing it smoothly and effectively.

QA professionals in these positions can see the QMS blank slate as the opportune time to show off their talents. These attempts to impress senior management, however, can often leave the fundamentals out of the plan, creating an overly complex QMS with expensive bells and whistles that the organization doesn’t need. Here are some tips to help keep the basics in mind when you’re transitioning from an empty canvas to an efficient QMS masterpiece.

Simplified procedures

The most efficient way to meet regulations is to create or adapt procedures that satisfy the requirements. If you’re clever, you’ll try to combine as many requirements as you can into one procedure. I’ve seen several new organizations end up with too many procedures, far exceeding what’s required per regulation.

While it’s understandable to ensure consistency and compliance (and possibly job security) by creating as many procedures as possible, it’s often unnecessary. When an organization begins to document how many office plants employees may have at their desks and the frequency at which they must water those plants, the procedures have officially gone to the extreme. Put the watering can down and step away from the procedures.

My recommendation to managers who create excessive amounts of procedures is to first identify and set aside procedures that must be in place to meet regulations. Second, take those procedures and identify what can be grouped together.

For example, there is absolutely no reason to have separate procedures for corrective actions (CA) and preventive actions (PA). Combine those systems, slap a CAPA label on it, and call it a day.

Lastly, assess what’s left and identify whether those procedures truly streamline processes for your organization. Do they add value and make life easier for your employees? Or do they make life more difficult and increase workload?

The rule is this: If you must have a ridiculous procedure, make it as vague as possible. Go ahead and create that standard operating procedure (SOP) on watering plants, but don’t specify how and when to water them. Simplify it to: Plants in the office must be kept alive. Then buy a cactus. If you accidentally kill your cactus, get yourself a silk plant and write yourself a CAPA.

Regulatory vomit

I have had the pleasure of creating several QMSs from scratch for smaller organizations in my career. During that first week with a new employer, I wanted to wow them with my wealth of knowledge and create SOPs filled with quotes from the U.S. Federal Drug Administration’s (FDA) Code of Federal Regulations (CFR). I would reread my SOP creations and realize I’d just summarized the entire regulation without providing actual procedures on how to operate and meet the regulation.

My SOPs were filled with something I call "regulatory vomit." I’m referring to verbiage and legal diction so convoluted that the true meaning of the document becomes unclear. Regulatory vomit will always get you into trouble; but unfortunately, upper management loves having it in its procedures.

Regulations are written broadly to allow organizations to interpret the regulations as they see fit. Although documents that provide guidance are available, organizations often overlook them and simply copy and paste the regulation into their procedures.

If the FDA didn’t want manufacturers interpreting regulations for what’s easiest for them, the CFR would have been titled the Code of Federal Procedures. Many regulators view regulatory vomit as: "We don’t know what we’re doing, so we’re just going to copy and paste what you told us to do to keep you happy."

Regulatory vomit is hard to clean up, especially if it’s found by an auditor. Many organizations will spend precious resources pulling employees from other projects or hiring consultants. Other organizations simply reword their procedures by filtering every word through the thesaurus function of their Word document like college students who don’t want to be caught plagiarizing term papers.

Simplifying the language within a procedure is the best strategy for meeting compliance. If your SOP does not include clearly written instructions on how to perform specific tasks, rewrite the procedure. Your SOP shouldn’t be filled with regulatory vomit to impress your co-workers, upper management or auditors. It must be filled with simple, step-by-step procedures that meet regulations and are easy to understand.

Acronym soup

I’ve worked with colleagues from various backgrounds—aerospace, mechanical, automotive and others not under the scope of the FDA— and it sometimes went unnoticed that our co-workers were unfamiliar with our industry-specific terms.

Once, during a design development meeting, we gathered opinions from people around the room. We turned to James, a new hire who had no FDA experience, and asked him how he felt about the PDP SOP and DES procedures on NPD as part of our QMS.

James stared blankly. I couldn’t help but laugh as I watched his head swirl from all of the acronyms we’d thrown at him. I calmly explained to James that I created a matrix to summarize each of the acronyms so he wouldn’t feel so lost during our meetings. I referred to it as the quality acronym matrix, or QAM. It did not escape me that I referred to my acronym sheet with an acronym, and James’ experience proved that there had to be a better way.

There are many different ways to overcome acronym soup. It may seem burdensome to consistently reference the full name of a system within a document, but doing so will allow a reader from any background to fully comprehend your procedure.

Another great way to ensure industry-specific acronyms are fully understood is by creating a cheat sheet of acronyms and their full definitions for employees to leave on their desks for quick reference.

Acronym definition sections used in procedures can work well. But if you find your procedure requiring new hires to repeatedly refer back to the definition section, it’s time to simplify the procedure and spell out the terms.

Know your audience, know their background and build to that. Identify the size of your QAM and how relevant it is to refer to the manufacturing break room as the MBR.

Approval paper trail

Consider this scenario: You spend weeks creating the perfect CAPA procedure, and by your standards, it’s a work of art. You print your masterpiece, attach it to a change control form and away it goes into the magical land of reviewing and approving.

You trust that your operations manager will pass it along in a timely manner to the regulatory manager, who will pass it to the engineering manager. More often than not, however, you find two weeks have passed and you’re tracking down the last person who had it. It will most likely be found under a pile of other important, but forgotten, documents on someone’s desk. That’s when you realize the only way you will get reviews and approvals on your masterpiece is by being persistent and physically present throughout the process—and this is just the first step.

For big organizations with deep pockets, implementing a fancy document control system is the most efficient way to streamline the process. Everything you need is contained in one easy-to-use system, generating emails to approvers, walking you through each step, identifying gaps, and all of it is done without the ridiculous paper trail.

The setup and validation of this system is burdensome and costly. In the long run, it’s an efficient, timesaving investment for the organization. In my experience, even if your organization can afford the large investment, it is often unrealistic and impractical to implement an electronic document management system.

Depending on the organization’s size and the planned use for the system, an organization whose main document approvers sit in offices next to one another—and their primary objectives are to implement their entire QMS as quickly as possible—may find that going paperless is not practical in the short term. The cost associated with these systems typically drives organizations to stick with the old-fashioned paper system.

Don’t always assume that the bigger, faster, shinier system is the best fit for your organization when first developing a new QMS. It can create more headaches than added value. Establish long-term and short-term goals, and you may find that the most basic approach to handling your documents is the least burdensome.

Before rushing into systems and procedures, QA managers should ask themselves: What will this procedure look like to auditors? Will they understand it? How many procedures will they need to view to verify compliance to a system? What happens if, a year from now, this electronic document management system goes under?

I’ve found that stepping back, asking why and insisting on returning to a simpler way of doing things can streamline a process and create a better workflow. Focusing on the basics helps evaluate the fundamentals of why we’re doing something in the first place.


Denise Wrestler is senior manager of quality assurance and regulatory for Austco in Irving, TX. She holds a bachelor’s degree in chemical and biomedical engineering from the University of California-Irvine. An ASQ member, Wrestler is an ASQ-certified quality auditor and engineer.



good informative ideas
from a blank entity, etc. / blank canvas to a masterpiece of QMS in strategically prioritizing quality objectives to fulfill different levels of consistency and compliances; a list of quality acronyms / requirements / quality acronyms matrix is a good idea.

Aylin N. M.
CQPA, CQE, CQA
--AYLIN NAFIA MINIKUS, 12-30-2017


This matches my style exactly. The only thing I do differently is regarding Regulatory Vomit. I include this jargon so the person being audited will not be intimidated when the auditor uses it. (i.e. Show me your procedure for product realization.)
--Rick Paul, 07-31-2015


EXCELLENT advice and synopsis of the process! I've spent the last 8 years trying to simplify an over-blown system provided to my company by an external consulting firm due to all of the bloat mentioned in this article.
--Steven Cooke, 05-25-2015

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