Simple CAPA Status by Manager Metric Template

Today’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.

Document Change/Release Order (MS Word)

Today, 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.

Quality Resource – Product Validation Protocol Template (MS Word)

If 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 standing downloads always 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.