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Posts Tagged ‘Quality Resource’

Please Visit; CAPAtrak is Being Retired

Posted by Diane Kulisek on June 22, 2016 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,, for resources previously downloaded from these sites. You may also want to follow the LinkedIn Company Page to stay on top of new offerings. I will announce creation of the 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 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 »

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: , , , , , , , , | 9 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 »