Quality Management 2.0 Blog

An Ocean Can’t Protect You from Compliance Fallout

Posted by Mary McAtee on Nov 05, 2014 @ 10:00 AM

REACH

There is a great book by a fellow named SQuire Rushnell called “When God Winks”.  He and I share prettyflaming_shots
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Topics: Compliance Software

Medical Device 4th Annual Summit - IBS America Invitation

Posted by IBS America on Feb 21, 2014 @ 03:00 PM

Are you planning to attend the upcoming Medical Device 4th Annual Summit show in Boston, MA?

Are you facing questions and concerns as it relates to staying on top of regulatory updates, competitive designs and new opportunities?  

Being held at the Marriott Long Wharf, this conference is the perfect place to find what you need to accelerate your project to completion by meeting with key suppliers who can address your questions about compliance, quality and regulatory.  25+ key leaders provide the latest and most critical insight into the medical device and larger health care industry.

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Topics: Quality Management Systems, Quality Management Software, IBS America, Tisha Tomlinson, Quality, medical device compliance and quality software, medical device summit 2014, Compliance Software, compliance

Are We Really "Predictably Irrational" with Our Compliance Systems?

Posted by Jim Verzino on Oct 02, 2013 @ 02:16 PM

Why do we continue to make decisions that are not in our own best interest, and often not in the best interests of our organizations? Why do we let our finances, our relationships and our quality management systems and environmental management systems work at sub-optimal levels?

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Topics: Quality Management Systems, Quality Management Software, IBS America, QMS, Environmental Quality Management, Compliance Software, Environmental Management System, Environmental Management Software, Environmental Compliance Software

How Education is Ruining Your Compliance Initiatives...

Posted by Jim Verzino on Aug 08, 2013 @ 02:52 PM

How Education is Ruining Your Compliance Initiatives - And What You Can Do About It

Over the last several weeks we dove into a series on “3 Keys to a Successful Integrated Management System,” and one of the sections focused on cooperation. A key part of cooperation is letting creativity flourish. Today, we will dive into both creativity and collaboration (in our school days known as cooperation).

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Topics: Document Management Solution, Jim Verzino, IBS America, Document Management Software, CAPA Software, CAPA, Corrective Actions and Preventive Actions, Document Management Systems, Compliance Software, document control, corrective and preventative actions, compliance

Managing Supply Chain Risk in a Complex World

Posted by Mike Richman on Jul 17, 2013 @ 01:41 PM

It’s been said that supply chain risk today is riskier than ever before. Why? Well, there are several reasons.

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Topics: Quality Management Systems, Supply Chain Management, Quality Management Software, Food and Beverage Control, Quality, Compliance Software, Supply Management Software, Supply Chain Risk, ISO Quality Management System, Mike Richman, Quality Digest, Supply Chain

Stop Wasting Everyone's Time With A Disjointed QMS!

Posted by Jim Verzino on May 01, 2013 @ 02:23 PM

We are all doing triple the amount of work that we need to do, and most of us don’t even know it!  At the same time, we are making things more difficult for everyone around us.  The saddest part is that we’ve been doing it for a long time.

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Topics: Quality Management Systems, Quality Management Software, Jim Verzino, IBS America, CAPA Software, CAPA, Environmental Quality Management, Health and Safety Software, Compliance Software, Environmental Management System, Environmental Management Software, Environmental Compliance Software, Environmental, Social and Governance Management

Task Tracking in EQMS

Posted by James Hartford on Nov 20, 2012 @ 10:02 AM

In today’s fast paced business environment, it is has become harder and harder for those concerned with quality management and service delivery related activities to keep track of all of their responsibilities as well as their required tasks without something falling through the cracks.   The days of the yellow sticky note no longer suffice as a tool for us to organize the myriad of activities we are not only responsible to complete but also monitor and oversee.  Our never ending attempts to remain focused appear to be futile in that we are growing ever busier and become easily derailed by sidebar activities and impromptu scheduled events.  One advantage of having IBS software to manage quality processes is its ability to organize and streamline activities to address just these problems.

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Topics: IBS Company News, Automotive Quality Management, CompliantPro, Quality Assurance and Quality Control, Customer Management Software, Corrective Actions and Preventive Actions, Compliance Software, Risk Management, Cost of Quality, Quality Data Management, Customer Q&A, Track & Trace, Crisis Management

Technical Tips - Customizing the Email Messages in CompliantPro

Posted by James Hartford on Oct 23, 2012 @ 11:51 AM

Here's a quick example of how easy it is to change the messages sent by IBS software. Suppose you want to change how the email-message that is sent when a Training Record is coming up for renewal. For this example, suppose you would like to indicate in the Subject line the name of the person whose record this refers to.

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Topics: Document Management Solution, Document Management Software, CompliantPro, Document Management Systems, Compliance Software, Complaint Management, Employee Training Software, CompliantPro Tips and Tricks, CompliantPro Training and Qualifications

What is the Key to A Successful Electronic Workflow?

Posted by Tisha Tomlinson on Oct 19, 2012 @ 11:00 PM

When developing a new business electronic workflow in a quality management system, always think ahead to what happens to all the data collection.  Thinking ahead to determine what metrics will be needed out of the process will ensure a successful implementation of the new process.  Any vital business process should be measured for continuous improvement. Therefore, metrics should be a top consideration when developing an electronic process.  Too often, much financial and human resources go into the development of an electronic workflow tool only to find out that the necessary metrics can’t be captured because thought wasn’t put into how the data should be stored.  When I assist clients with defining a new electronic business process, the first question I always ask is:  What type of metrics do you need out of this process?  That will inevitably lead to a discussion that might not have been addressed before.  It also opens up discussion about what metrics they have never been able to track before and is an opportune time to introduce them.
 
Scenario:  When creating an electronic Customer Complaint tracking system, vital pieces of information should be captured such as:  Customer Name, Date of Complaint, Reason for Complaint, Resolution Date, etc.  If these fields are simply data entry fields, all metrics are lost.  If users simply type in a customer name each time a complaint is received, there will be nothing to force consistency.  Therefore, when a pareto chart is assembled by customer name, nothing of any value will render.  It is necessary to give users some type of selection list of customers.  This will then provide consistent trends to determine which customers have the most complaints.  The same would apply for date fields.  If cycle time is a key metric, the  system should capture that information in a date value field.  The same theory applies to a categorization of Reason for Complaint.  Providing users a selection list for the primary “buckets” of reason types will give a fuller picture to the types of complaints being received.  Other field considerations should be:  integer fields, currency fields, numeric fields, etc.  Generally text fields are of no value in metrics, but will provide detail if a “drill-down” is needed.  Analyze each field type carefully to ensure data structures are compatible with expected results.
 
It seems reasonable to create the fields types indicated above, but often the workflow focuses on aesthetics and ease of use more so than the correct data structure.  All of these items are important to consider, but ultimately, metrics should win out without compromising the workflow acceptance by the user community.
 
So, when introducing a new electronic workflow, remember:  the key to success in the future is thoughtful planning in the present!

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Topics: Quality Management Systems, Electronic Document Management, Customer Management Software, Compliance Software, Workflow Management Software, Complaint Management, Electronic Workflow

Addressing Multiple Regulatory Requirements with EH&S

Posted by Mary McAtee on Oct 02, 2012 @ 10:00 AM

I was conducting a planning session with a new client recently and as I looked around the room at the implementation team I asked who was representing EH&S? I knew they had purchased the EH&S modules but they weren’t represented in the project plan and time line they had presented to me.  The team leader responded that I would be meeting with personnel from the Environmental Management Group and Corporate Safety Team for separate planning sessions, plural.

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Topics: Quality Management Systems, Environmental Quality Management, Compliance Software, Environmental Management System, Environmental Management Software, Environmental Compliance Software, 9001 Software, EQMS, Regulatory Requirements with EH&S

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