“Chance is a word devoid of sense; nothing can exist without a cause.” – Voltaire
“For every complex question there is a simple answer, and it is wrong.” – H. L. Mencken
The dreaded quality complaint – no one wants to have one of these opened against them, but here’s an open secret: nobody really wants to complete them either. It can be nearly traumatic to find a cleaning rag in your bioreactor, foreign particulates in your tris, or abnormal data from your last run. These are the scenarios that quality systems are literally designed to avoid.
Take a deep breath, though. As much as you might want your complaint closed as quickly as possible, this is an opportunity for positive change. Over a quarter of a century ago, Stephen Covey wrote “the way we see the problem is the problem.” People are resourceful, resilient, and creative, and they’ll find a way to muddle through the present state and make things work. But when that key contributor is on vacation, medical leave, or takes a new position, your organization needs a solid process in place to make sure everything is cGM-peachy.
Drawing on my personal experience in supply chain management, here are some tips to ensure that your complaints are productive:
Not everything needs to be a Corrective Action or CAPA
If everything is critical, nothing is critical. If a cover-sheet has a typo, or you didn’t receive a certificate of analysis once, filing a Corrective Action is overkill. If it happens five times in a month, then you’ve got a pattern that bears investigating. Save Corrective Actions, and especially CAPAs, for truly important, business-critical issues so that they’ll stand out and get the attention they deserve. You don’t want your nonconformance to be a needle in a stack of needles.
Rule out internal causes first
It’s tempting to blame a nonconformance on an external party, and you might very well be right. Still, do the right thing and rule out any factors on your end first. More than a few times, I’ve seen a customer’s third-party testing lab turn out to be the source of a contaminant. Maybe a material isn’t really lost, but was put away in an easy-to-forget place. That irritating sodium chloride that’s clumping might mean you’re carrying too much inventory which sits for just a bit too long.
Using precise language avoids confusion or assumption. Be descriptive about what the problem is, who discovered it, and when the nonconformance happened.
Show your work
Yes, your 5th grade math teacher was right after all. Your staff went to the hard work of receiving the material, dispositioning it properly, sampling it, analyzing the chromatography, and creating an internal report. Why not let their work speak for itself? Hard evidence will make it far less likely the true root case will be glossed over.
A picture is worth a thousand words
More than anything else, I’ve found that pictures of the nonconformance lead to a positive outcome. It’s hard to argue with a piece of hair or blue plastic in a drum of pearl-white material. Don’t be shy! Snap some selfies if you really want that credit or return.
Specify what you want
Is your complaint purely for notification purposes only, and doesn’t cause the material to be removed or quarantined? Do you want the material to be picked up (yesterday)? Are you seeking a credit? If you’re sending a complaint to three different suppliers because you’re not sure where it originated, let your vendor know up-front. It will help them prioritize the complaint, and truly urgent nonconformances can be resolved swiftly.