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Posts Tagged ‘quality management system’

Top Three Small Business Quality Problems

Posted by Diane Kulisek on December 21, 2009

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:

  1. Regulatory compliance;
  2. Superstition; and 
  3. 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.

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Posted in Blogroll, Day-to-Day Observations, Quality-Related LinkedIn Answers, Social Commentary | Tagged: , , , , , , , , , , , , , , , , , , | 1 Comment »

ISO 9001 Management Review Agenda Template

Posted by Diane Kulisek on November 8, 2009

Management Review Agenda Template

Click Image to Download

This editable MS Word template addresses the agenda ‘inputs’ required by ISO 9001 and can be downloaded immediately.  No request form needs to be filled out.  Just click HERE or on the image of the template.

One of the basic requirements of ISO 9001:2008 is that a Formal (documented) Top Management Review of the Quality Management System be held at planned intervals (reference: Section 5.6 of the standard).  It is typical for third party assessors to require a planned interval of: ‘at least once per year’.  

There are specific ‘review inputs’ (topics and accompanying data) that must be addressed during the review in order to comply with the standard… and there are specific ‘review outputs’ (outcomes, including actions) that must be achieved. 

For a list of all records required by ISO 9001:2008, visit the ISO website and take a look at the table at the bottom of ISO/TC 176/SC 2/N525R2, “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008”  titled: “Annex B: Records Required by ISO 9001:2008”.

While the agenda for the Management Review is clearly prescribed within the ISO 9001 Standard, the formats for the supporting documentation, or effectiveness thereof, are not.  One company I worked with had identified exactly the same critical resource need to support quality outcomes for over five consecutive years … and had not made any effective progress in addressing that need.  Every year, the inadequacy of the Corrective Action System was noted in the minutes of the Management Review.  Every year, the third party assessor had also cited a ‘minor’ finding against the Corrective Action System.  Still, five years in a row, not a single improvement had been made to the Corrective Action System.  This did not prevent the company from maintaining ISO 9001 certification, however, because the minimum requirements of the standard were met.

It may be tempting to pay lip service to a requirement for continual improvement just long enough to pass a third party assessment, but the damage caused by the dishonesty or insincerity of top managers can potentially cause far more damage to an organization than the cost, if any, of diligent, steady, practical, incremental, improvements over time. 

The difficulty of allocating precious few resources to a system that does not seem too badly ‘broken’, especially in a tough economy, is understandable.  In my opinion, however, the cost is not always the issue.  Although pie-in-the-sky promises are often well-intended, the real challenge can be not to bite off more than the organization can chew, so to speak.  Overly ambitious plans for improvement fail as surely as dishonest ones.  Limiting planned improvement efforts to what is practical, instead of what might be possible or what is wished for, can still provide steady improvements that support positive change over time. 

I recommend a conservative approach to addressing resource needs that arise in Management Reviews.  Many organizations hold monthly or quarterly operations reviews.  Why not address the requirements of the ISO 9001 Management Review in meetings that occur more naturally and routinely for your organization?  Make a conscious team effort to manage required Quality Management System resource allocations and actions as part of the normal way you do business.

Whatever the frequency of your Management Reviews might be, the template provided will empower you to assure each required agenda item and outcome is addressed in compliance with the ISO 9001 standard. 

If this particular Management Review Agenda Template doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 537 MS Word document hits when I entered this search string:  “iso 9001 management review agenda template filetype:doc

As always, if you need a particular template, metric, form or advice on any other quality-related matter, feel free to contact me.  I’ll be happy to do what I can to help.

Posted in Tools and Methods, Science and Technology | Tagged: , , , , , , , , | 8 Comments »

Document Change/Release Order (MS Word)

Posted by Diane Kulisek on October 6, 2009

DocChangeRelOrdToday, I dug around in my goodie bag and came up with this Document Change/Release Order template.  If you’re in a hurry, you can click on the image to the left to request this Quality Resource, now.  It is a fully-editable MS Word document.  You can add a company logo, delete an approval block, change a document category, or do whatever else best suits your purpose.  This type of document is also often referred to as an Engineering Change Order or Request (ECO or ECR). I prefer to use the term “Document” instead of “Engineering” because not all documents requiring control for an effective Quality Management System are Engineering documents.  It may not be perfect, but it has passed many an audit by ISO 9001 registrars. 

Every company I go to work for seems to struggle with how best to manage the change process for their documents.  All would like a simpler, faster way to do it.  I’ve tried automating the process using the MS Outlook features for collaborative review.  There is a Microsoft Partner application called Workshare that looks pretty good for this.   At one company, we used Carmen, a document control application from another Microsoft Partner, Manedge Software.  That was very affordable and worked well, too.  If you’re in a larger organization, it might be worthwhile to invest in some of the more sophisticated enterprise solutions for document control, such as those provided by MasterControl.  There are certainly more applications available, but these are the ones I’m familiar enough with to tell you about. 

I should probably mention that the ERP modules for document control that I’ve seen do not seem to work very well.  They’re just a bit too easy for the average employee to hack around.  I’m not going to cite ERP application names here.  Suffice it to say I’ve tried several.

As always, if this particular Document Change/Release Order template doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 116 MS Word document  hits when I entered this search string:  “ECO, document release OR control OR request “engineering change order”  filetype:doc”.  There also editable Document Control templates/examples available formated as Excel worksheets and as Access-based data entry ‘forms’.  Just change the filetype in the search string to reflect the type of document you prefer.

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.  I’ll be happy to do what I can to help.

Posted in Tools and Methods, Science and Technology | Tagged: , , , , , , , , , , , , | 3 Comments »