2020

EXPERT ANSWERS

This month’s question

What if executive leadership ignores quality? I’ve encountered leadership that is focused on the appearance of quality, but actively suppresses it. What can a manager do in these situations?

Our response

Sadly, lack of upper management support is rampant in all industries. The lack of leadership buy-in trickles into the quality system and results in lost sales in the form of high complaint rates, sometimes resulting in a recall or other detrimental outcomes.

Ideally, leadership would take a more proactive approach to quality. Most of us, however, would be happy if leadership took any sort of approach, even if reactive. And a minority of us will experience neither. As quality professionals, we must decide: What then? How can we continue to be quality professionals in organizations that aren’t focused on quality?

Action through numbers

Most upper management is focused on the bottom line and money. After all, an organization can’t be successful if it isn’t profitable. If you can quantify the importance of quality in these ways, go this route.

Do you have scrap and rejection rates, or the costs associated with returns? It may be beneficial to run a cost analysis. Include not just physical inventory replacements, but also employee time. How long does it take customer service to receive and handle a complaint? How long does it take the quality department to investigate and find the root cause? How long does it take manufacturing to assemble a new component? How long does it take warehouse employees to put it on a pallet and ship it?

Management may not see all the costs associated with poor quality, so if you have that information, use it to paint a complete picture.

Action through example

Was a competitor’s product written up by a regulatory firm? Did it issue a recall? Is it reporting lower sales? Did it go out of business? If so, share this with management. Include any negative information, such as negative publicity on social media, declining sales and even jail time, if your competitor did something horrible. Reiterate that your organization cannot go down this path, and the only way to prevent it is by committing to quality. A relatable scary story may be just what management needs to take action.

Action through CAPA

Did the quality assurance director promise to add three new quality control inspectors last year, but hire no one? Did he or she promise to outsource your calibration services so you’d have more time to review complaints, but didn’t follow through? Are items missed in inspection records because you haven’t had time to revise the procedure?

If this sounds familiar, put it in a corrective and preventive action (CAPA) record. Most organizations have a CAPA system that handles quality-related issues. If informal actions aren’t being addressed, put them in writing. Assign a responsible party and due date. Require weekly project updates to see how CAPA implementation is going. Assigning accountability to individuals—not departments—typically generates traction to get things done.

Action through audit

During my audits, I ask management how it feels about quality. I ask specifics about its policy and some higher-level items, but also about recent complaints, just to see if management really knows what’s going on at lower levels in the organization.

I ask the quality team this same question. If I sense things could be better, I continue probing to get a feel of what’s going on. I find that management reacts to deficiencies when they’re formalized, such as in an audit report.

As an auditor, I appreciate candid responses and comments, and ask the quality team if there is anything specific I should address in my report as an opportunity for improvement. If you have the opportunity, talk to others who may have a higher-hand at making changes in your organization.

Extreme action

In the end, you are the best judge of what could work, and what inaction can do to your organization. If you’re not making progress, it may be time to leave. But try every angle first—continue to be patient and measure your own progress. Use emails to document what really is going on and to clarify decisions. This minimizes your liability and makes it clear to management where you stand.

Ultimately, after every attempt has been exhausted, the decision to leave is up to you.


This response was written by Denise Wrestler, QA/RA Consultant, CYA Medical Device Consulting, Carrollton, TX.


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