Quality Policy awareness records

[Bev D]

Hmmm. Sure check that box. Unfortunately too often this question is directed at operators when it’s supervisors managers engineers buyers marketing and senior executives that should be asked this question and asked to demonstrate how they upheld and executed the ‘policy’ in the last week.
Basically the only real answer for operators is that they follow their processes. Which they are already audited on. The weakness remains that simply understanding or quoting the policy is a waste. How is the policy implemented? Give me examples. That has some value.

 

[Sidney Vianna]

Every employee should be prepared to answer the auditor question "What is one action you personally take in the course of a typical workday to put the quality policy into practice? Can you show me how you do that?"

Let’s speculate some possible answers:

1. I follow the procedures
2. I do what my boss tells me to do
3. I do my job to the best of my ability
Etc.

Is there ANY reasonable answer that would “fail” the question? If not, the question has questionable value. People on the floor are already typically wary of interacting with an external auditor. Some flowery question will likely be misunderstood.

 

[Golfman25]

I am so happy to see these comments. Agreed 100%. What do folks recommend instead of a documented policy that no one reads?

It's pretty simple. It's either your company culture or not. A "written" policy that people are tested on every year won't change jack squat. Not sure ISO can mandate culture, but this is their feeble attempt, imo.

 

[Tidge]

Bonehead auditor.

This exact situation has happened multiple times in my facility, the FDA inspectors like to ask this at random when dealing with shop floor personnel.

Asking folks encountered about the Quality Policy is pretty common with FDA and 3rd-party13485 auditors, as a QP was required in the 2016 version and required to be communicated and understood to the organization. Maybe the scale is different outside of 13485.

People on the floor are already typically wary of interacting with an external auditor. Some flowery question will likely be misunderstood.

100% this... which is why we handed out "Miranda rights" cards (to demonstrate trivially that the shop guys *had* access to it), and for 99% of them they were capable of answering "I make stuff to print and I check my work."

The few meltdowns were because less experienced folks on the floors had a certain sense of fear drilled into them (about the Quality Policy) which IMO ought to have been sufficient evidence that maybe that org was misapplying the concept of a Quality Policy.

 

[ScottK]

All this being said, in 30 years of ISO9001 and ISO13485 I've never gotten dinged for anything to do with the quality policy, even when a line operator panicked and completely blanked.

 

[Randy]

All this being said, in 30 years of ISO9001 and ISO13485 I've never gotten dinged for anything to do with the quality policy, even when a line operator panicked and completely blanked.

It's one of those moronic things they put into the "document", and "understanding" is one of the biggest BS things there is........EXAMPLE........We've got 9 Justices on the US Supreme Court, highly educated, and experienced in their own right and as an auditor I'd fell safe in saying "COMPETENT" as the ISO has defined it.......Anyway 9 different people looking at the exact same thing, the "POLICY for th USA" known as the Constitution of the United States. There is no doubt in my mind they "understand" it, so how in the devil can 9 competent people "understand" the exact same words, written 220 odd years ago, and not come across with the same words as to their "understanding" and come to 9 different "interpretations" based on "their" understanding"? And here we come, with the expectation that people, whose sole goal is to put the right screw in the right hole, or make sure there are 3 of something and not 2 or 4, or sweep the floor, "understand" the intent of some writing on a card dangling around their neck on a cord, or tacked to the wall above a urinal or water fountain. GIVE ME A BREAK YOU THAT INSIST ON DOING THAT! The asking people of people, who are probably really busy making stuff anyway, their understanding of "THE POLICY" reminds me more and more of a quote from the movie (either version) of the Manchurian Candidate "Bennett Marco: Raymond Shaw is the kindest, bravest, warmest, most wonderful human being I've ever known in my life."

It's extremely important that people know more of the why and how they themselves fit into the puzzle than what the puzzle actually looks like.

Me? I do a mish-mash way of verifying understanding starting with overall metrics, NC product issues, customer complaints and such. With the "people" it's a mixture of ways like asking what they do and why. Normally in conversation the word "customer" will come up....."Who cares, you never see the customer, you get paid anyway" and that's when the evidence of "understanding" comes out and it comes out without ever once creating a brain lock by asking about "THE POLICY" (which all say the exact same thing as I earlier posted).

OK, back to writing this week's recertification audit report, and it went well except for all the tornados around us Monday night (5 total).

 

[Jen Kirley]

Lots of good responses here.

The standard requires a policy and that it be documented. Let us not make it difficult.

All this being said, in 30 years of ISO9001 and ISO13485 I've never gotten dinged for anything to do with the quality policy, even when a line operator panicked and completely blanked.

Same here. I have seen some very long and flowery language in Quality Policies. I don't like asking about it at all because it terrifies the auditees and in my view that effort for memorization is pointless. Even if they've learned to recite it like the Pledge of Allegiance (which it absolutely is not) or it's little more than a bumper sticker (I remember from my past "Good stuff on time, every time") they are apt to freeze and then the poor soul comes undone for the rest of their interview.

As has been said, the point should be that they can tell me how they support the effort. But even that is usually a struggle. If they can say "It's posted on the wall" or "I have this card in my badge pouch" we know it has been communicated. If they can tell me how they go about doing their part to ensure customer satisfaction, the intent is met.

 

[Bev D]

If you really MUST ask about the quality policy stick to asking salaried people; better yet ask the executive staff and ask for examples of how they not only support it but have taken action to ensure it... Asking floor operators and other front line workers is pointless at best and inhumane at worst. Just stop.

Here’s a story: we had a typical QA generated Quality Policy. And it was audited primarily by asking the front line operators - even by our internal auditors. BUT the real quality policy was a ‘saying’ of the CEO: Never experiment on the Customer. He said it frequently. He explained it frequently. His target audience was the scientists and engineers and their managers who developed our products and made changes to the products or managed the supply chain that made changes to the materials used in the product. Every single salaried person heard this one personally several times a year. He got pretty demanding about it when a change got out unvalidated and the defect/failure was experienced by the Customer…Everyone understood his intent. Everyone could quote it verbatim…but that didn’t mean that it was followed. Some scientists and engineers simply thought it was insulting to their skill and knowledge and expertise. They were wicked smart - smarter than any stinkin’ validation. That was just a waste of time. Another waste of time was rejecting product that failed testing or that the operators said was ‘wrong’. After all the manufacturing supervisors and managers were judged on quantity - meeting the build/ship schedule - not the quality of the product. And of course bad stuff got out to the Customer…Now this wasn’t rampant; most people knew what the right thing was and they did it, but there was a persistent even if small group of people who adhered to the old ways of “just ship it, gotta get that money”.

Quoting and understanding are irrelevant.

So go ahead and check your box by torturing and harassing the front line workers; everybody else does. Don’t make a move that will expose the real quality hole behind you that creates an open door to ship poor quality.

 

[Gialandon]

How in the world do you intend to verify & validate understanding? You can communicate until your face turns blue and your fanny falls off but you can't "mandate, force feed, or inject understanding". Understanding is something that can't actually be quantified the best one can do is ask "what does it mean to you?" or "how does it effect you?" Understanding and awareness isn't reciting back or reading from a goofy card (like I had shown to me 10 times this week alone). Part of what I do is look at complaints, nonconforming product, internal audit results, customer satisfaction, achievement of objectives and a ton of other things as part of my evidence of awareness and understanding.

Shoot, I "understand and am aware" of your policy right now and I've never seen it and probably never will....."We're going to do good stuff all the time, do our best to make our customers happy, fix what's broke, cross our goal lines and do our best to do things better."

Pretty close?

We have a planned roll out with information being communicated at several different layers - In short I want the business to focus on these activities & yes we do assess if the intent of the quality policy is being delivered through the Management reviews.

In terms of meeting compliance requirements I know auditors will often ask for evidence. In the past we provide a training record. Just wondering if there is a better way of meeting the compliance requirements. I am under no illusion that signing a training record means employees understand.

 

[Gialandon]

SCENE: Manufacturing floor. AUDITOR is accompanied by PLANT MANAGER who is guiding a tour. the tour group approaches a work station with an ASSEMBLER.

AUDITOR (to assembler): Hello, Do you know what the Quality Policy is?

haha, yes I get it.
And yes there is a program to enable the organization to understand the policy and I don't think signing a training record means they understand. But I'd rather have a record I can show. We have about 5000 people on site with many being in the factory. There will always be someone who if asked won't know about the policy.