Lonnie Mitschelen, ASQ CMQ/OE, CQE, CQA, CSSGB, Quality Assurance Engineer at Spectrolab and Owner of Can Do Quality, asked the following question on LinkedIn:
“What are the top three quality problems facing the small business (manufacturer, service provider or retailer)? Additionally, what would you expect or want from a consultant to help resolve those quality problems? Develop a system/process? Perform a task? Train or teach? Some combination of the above? Or, something entirely different?”
Diane Kulisek, then working as a consultant, provided the following ‘Best’ rated Answer:
“I would have to say that the problems I encounter most have to do with regulatory compliance and superstition. The third would, of course, be inadequate resources to deal with either regulatory compliance or superstition effectively.
So, the top three problems are:
- Regulatory compliance;
- Superstition; and
- Inadequate resources
(although, not necessarily in that order).
Let me elaborate and provide some possible solutions from a consulting perspective, in response to the second part of your question.
I recently attended a meeting featuring a top official from a regulatory agency. As I listened to him describe the new requirements being put forth by law (i.e. in the Code of Federal Regulations), I started to realize that many companies I would categorize as “small” (less than $5 million sales per year), could not afford to comply. I asked the official what consideration of the impact upon small businesses had been put forth, he answered: “You’ve obviously mistaken us for somebody who cares. Our mission is to protect the public… not to help small businesses survive.”
The harsh fact is that many of the current regulations are beyond the ability of small businesses to comply with, economically. This places those business owners in the tough spot of having to consciously violate those regulations until they can afford to comply with them, in hope that they won’t get caught during the period in between. Can you see the mindset this establishes among such business owners, however? And for those who survive…. they will carry that mindset into the management of their larger organizations, as well. Regulatory compliance, in other words, seems to become optional, unless you get caught.
With regard to superstition, although these same small business owners seem willing to accept the potential risk of being caught non-compliant, they will not accept the risk of bringing an outside consultant into their organization. I have found that small business owners are extremely resistant to the concept of contractors for quality management or engineering. For some reason, they seem to think that it is imperative to “own” their quality personnel. I’ve even offered outright FREE consultation to these types of small business owners, just in an effort to demonstrate its value, and had it refused. I can only speculate as to why. I don’t think its personal… because I’ve heard the same story from other quality consultants. My guess would be that, because small business owners ARE making decisions that are possibly against regulatory laws, they don’t want somebody who is not dependent upon them for their livelihood knowing about it. Yet, the very people who could best bring them into compliance, and do so most cost effectively, are those they could never afford to hire on a full-time basis…. a highly-qualified and experienced quality consultant. Go figure. [Side note from Diane now: If you have further interest about this part of the answer, you might want to read my article published in a past issue of the American Society for Quality’s Quality Progress Magazine, now available to the public via open access, titled: “Full-Time Quality Manager or Part-Time Quality Consultant“.]
As for the inadequate resources, answers for the first two issues and your consulting question would seem to say that a consultant COULD potentially offer an affordable solution for the first two problems to a small business owner… if given a chance. When employed, there were a number of situations where I would read a regulatory requirement that the other managers in the company thought was a “show stopper” and could show my employer why, within the same regulation, our company was actually exempt from having to comply with the requirement. I remember being challenged with words like: “I thought you were supposed to be ENFORCING” the quality regulation, not circumventing it!” I would respond by saying…. “I AM enforcing the regulation. I am NOT circumventing it. I am simply explaining to you why it does not apply to our operation. The exception is written right into the regulation… but you need to know where to find it.”
Postscript from Diane:
If you are starting a small business, there are more open resources available to help you bring your organization closer to compliance today than there have ever been in the past. Google(tm) is an amazing tool. You can find no cost or low cost webinars on just about every quality system or compliance topic. The U.S. Government posts every Federal Regulation and Compliance Guidance Document on-line, at no expense to businesses. There are several free on-line and paper copy trade publications that offer outstanding articles, tools and training. Discussion boards and answer pages, such as those offered by LinkedIn, empower you to ask nearly anonymous questions of some of the top professionals in the quality-related disciplines and receive timely answers, for free.
For ideas about how to implement a compliant quality-management system for your small business, I recommend you start by browsing the helpful links, downloads, forms, templates and presentation handouts provided at no cost to you via the CAPAtrak website.
Please Visit MyQACoach.com; CAPAtrak is Being Retired
Posted by Diane Kulisek on June 22, 2016
To loyal fans of downloads found via this Blog, you may have already realized that the CAPAtrak blog was a bit neglected. The last post was in (horrors!) 2009. Well, it is now 2016 and the world has changed. Please note that the CAPAtrak Website and the CAPAtrak Blog will no longer be maintained effective 01 July 2016. Please visit, MyQACoach.com, for resources previously downloaded from these sites. You may also want to follow the MyQACoach.com LinkedIn Company Page to stay on top of new offerings. I will announce creation of the MyQACoach.com blog as soon as it becomes available.
Many of the downloads previously obtained via this blog have been updated, along with some newer resources for you to download, and are now available via Diane Kulisek’s showcase page, which is accessible via her profile on the MyQACoach.com website’s “About Our Team” page. If you are seeking her Metrics Presentation, a Simple Dashboard Template, a Balanced Scorecard Template, Quality Plan examples and templates, including one for a Quality Planning SOP, or many free presentation materials, templates and tools for use in Root Cause Analysis (RCA) or Corrective Action and Preventive Action (CAPA) efforts, please visit Diane’s Profile and click on the link to “Learn more about Diane”, to find her Showcase Page.
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