CAPAtrak Blog

Comments on Quality

Posts Tagged ‘download’

Please Visit MyQACoach.com; CAPAtrak is Being Retired

Posted by Diane Kulisek on June 22, 2016

MyQACoach.com logoTo 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.

Posted in Blogroll, Day-to-Day Observations, Philosophy and Metaphysics, Quality-Related LinkedIn Answers, Social Commentary, Tools and Methods, Science and Technology, Uncategorized, Websites | Tagged: , , , , , , , , | Leave a Comment »

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.

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 »

Simple CAPA Status by Manager Metric Template

Posted by Diane Kulisek on October 12, 2009

simplecapastatusToday’s template is one I created for use in reporting Corrective and Preventive Action (CAPA) status (opened, closed, backlog) by manager.  If you’re in a hurry, you can click on the image to the left to request this Quality Resource, now.

The availability of sophisticated, enterprise-level, CAPA tracking and performance reporting systems is great … if you can afford them … and if you can afford to maintain them.  Unfortunately, that appears to be getting more difficult to do and, in my experience, has not often been the case.  A poorly maintained system can be (and often has been) worse than no system at all.

What to do?  Well, start small and work with tools that are familiar and easily accessible to everybody… like MS Excel.  Get the biggest bang you can for your buck. 

I have found that heightening personal accountability for timely completion of assigned corrective or preventive actions, by publishing the status of CAPA’s assigned to each person in an organization, can result in some pretty impressive returns on investment. 

For a small to medium sized company, this isn’t too hard to do using an MS Excel spreadsheet, such as the one provided here.  You can customize the reporting frequency interval to work best for you, but tracking by month has been a pretty effective way for most companies I’ve worked with to go.  If you’ve got a relatively high volume of CAPA activity, try weekly status updates.  If you hardly ever need to improve anything (because you’re just THAT good), go with a quarterly report.  You might even be able to get away with generating only a twice yearly or annual report for use in your Management Reviews.

If identifying people by name or title on a performance chart seems as though it may not be suitable for your organization, try using department names or product names, instead.

For each reporting interval, the template provided will empower you to graphically display the level of CAPA’s initiated to, closed by or in the backlog for each assigned person or group. 

There are as many ways to do this as there are people wanting to do it, of course.  You may prefer to switch to a classic Six Sigma Dashboard style and, if that’s the case, Dashboard Spy has a nifty example for you (click here).  If you’d like the software to do what you see on Dashboard Spy using Excel, consider QI Macros, one of my favorite salt-of-the-earth applications.  I’ve created a template for a Simple Quality Dashboard  using QI Macros.  The Simple Quality Dashboard template is always available for download on the CAPAtrak Website and I’ve seen it in use in many companies I’ve visited. 

If this particular “Simple CAPA Status by Manager Template” doesn’t seem to work well for your specific needs, try using Google to do a search for others.  I got 25 MS Excel spreadsheet hits when I entered this search string:  “capa status dashboard filetype: xls“.  

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: , , , , , , , , , , , , , , , , , , , , | 2 Comments »

Quality Resource – Product Validation Protocol Template (MS Word)

Posted by Diane Kulisek on October 5, 2009

ProdValProtIf you’re in a hurry, you can click on the image to the left to request this post’s Quality Resource, the Product Validation Protocol Template/Example in MS Word.
I realized, as I was getting ready to transfer my work to a new computer, that I have developed, over the years, many, many types of quality assurance tools, templates and examples that I could share.  The tools I’ve developed are typically in MS Word, MS Excel, MS Access, MS PowerPoint, Adobe .pdf and a smattering of other formats.
This will be the first such item I make available through my BLOG.  There are some other downloads that may be available on the CAPAtrak website, as well.

To get to the Quality Resources I’ll be sharing with my BLOG readers, I ask that you please use a Special Request Form.   Pardon the advertisements, please.  The form was able to be created, free to me, via Bravenet.com and I cannot currently justify the expense of subscribing to the form without them making their money via ads.

The good news is, if you use the form just once, you can save the final link to your favorites and just check back at that same URL when you see me mention a new resource here.  You could share the direct link with your friends, as well, but I hope you’ll afford me the courtesy of asking them to please use the form, as well.

By using the request form, I’ll know who cared enough to use my stuff… and I can keep those who do alerted to other new stuff from time to time.  Just so you know, I’m not exactly sure how to do that, yet.  I’m not going to load your inbox up with solicitations, that’s for sure.

Anyway, let’s talk about this particular resource.  As I began working in FDA-regulated companies, I realized that there was a need to structure the means by which new or changed products were ‘validated’.  Just so we’re clear, ‘validation’ means checking to be sure what you’ve got is appropriate for an intended use.  Validation is typically structured against the Product Specification, which will be used to drive labelling and product performance claims.  There are many ways to approach validation and each is uniquely tailored to a specific need… but I thought you might like to see a somewhat standard and simple format for a product validation protocol that has worked for me.  Feel free to use it as a template for your own validation efforts.

If this particular validation approach doesn’t seem to resonate well with your specific needs, try searching Google for others.  I got 474 MS Word document  hits when I entered this search string:  “validation protocol” filetype:doc .

As always, if you need a particular form or advice on any other quality-related matter, feel free to contact me.

Posted in Tools and Methods, Science and Technology | Tagged: , , , , , , , , , , , , , | 1 Comment »