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IBS has the solution for those who need to integrally address quality process management, traceability, production quality-data management, and compliance requirements. 

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The Latest Quality Management News

Catch up on the latest news in Quality Management with the IBS America, Inc. daily newspaper - a collection of quality articles from multiple authors and quality specialists.

quality management news

Read today's edition of "Quality Management 2.0 Daily"

Quality Management 2.0 Blog

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The Impact of Context on Nonconformance, Corrective Actions and Complaints (CAPA)

  
  
  
http://www.ibs-us.com/en/solutions/corrective_and_preventative_action/index.html

“Who’s on First”: The Value of Clear and Accurate Communication

Continuous Improvement with Document Management & Employee Training

  
  
  
Yogi Berra resized 600

Documentation and Training as a Means to Assure Continuous Improvement

“If you don’t know where you’re going any road will take you there”. This is a quote from a keen observer of human nature, the great Yogi Berra. I quote him frequently and in this particular observation he is totally on point. One of the keys to identifying and correcting issues is removing as many variables as possible in order to zero in on what works and what doesn’t. If you can’t reliably baseline a process you get trapped into either a false sense of security that everything is fine or you get entangled in chasing false issues.

Data Overload: Obscuring the Forest with Trees with Risk Analysis

  
  
  
http://www.ibs-us.com/en/solutions/risk_management/index.html

Statistical Analysis, Trending and Risk Assessment Pitfalls

One of the few gifts of being older is a sense of perspective. Interestingly it cuts both ways. For every situation where I am impressed by the immediate availability of Business Intelligence data I am equally perplexed by the seemingly conscious efforts of organizations to ignore or misread the data. There are all sorts of data collection systems that can keep a finger on the pulse of a process and the quality and risks associated with the outputs.

21 CFR Part 11 Software Validation As a Value Added Activity

  
  
  
Software Validation

Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in assuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA regulatory requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:

Using your QMS to Empower Change Agents

  
  
  
http://www.ibs-us.com/en/solutions/quality_management/index.html

“Give the people a light and they will see their way."  It was an unlikely source that brought this message home to me.

Life Science Software Validation As a Value Added Activity

  
  
  
pharma barcode scanner resized 600

Everyone that participates in the Life Sciences industry that uses software anywhere in their processes has wrestled with the challenges of Software Validation. Companies spend a considerable amount of time, money, energy and expertise in ensuring that they address all of the requirements necessary as defined in in 21 CFR Part 11 to make sure that the software is going to both satisfy the FDA Regulatory Requirements and meet business expectations. The most challenging validation portion seems to uniformly be Process Qualification (PQ). The time and effort to determine and address where the software capability ends and the human process interaction begins can be very challenging. It is easy to miss some of the important supporting elements that are absolutely required and necessary to make Process Qualification successful. If we were to quantify those requirements at a very high level it would boil down to:

Quality Management Data - Historical Analysis

  
  
  
quality management

Tribal Knowledge: Quality Management Data for Historical Analysis                                     

Ever since people began handing down information from person to person and parent to child, there has been something called tribal knowledge. Almost everyone can point to a specific skill they have or knowledge they possess that was transferred to them by an elder. This elder may have been a relative, a community member, a teacher or a coworker. I certainly rely regularly on wisdom and skills I gained from all of the above. One situation in particular stands out in my memory as a teachable moment I have never forgotten.                                                                       

Medical Device 4th Annual Summit - IBS America Invitation

  
  
  
medical device summit

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.

FMEA - An Underestimated Tool

  
  
  
http://www.ibs-us.com/en/solutions/apqp/index.html

Failure Mode and Effects Analysis (FMEA) is very often underutilized in many companies.  The key is to catch failures before they happen, thus reducing costs in the long run.  And in today’s world reducing costs while keeping quality up is an indicator for success in this global economy.  A lot of companies I visited recently have need for a tool that helps them manage their FMEA process.  But sometimes they just do it because they “have to” – their customer requires it, government regulations require it or it’s just to simply please someone else’s needs.  A more functional approach would be to use software solutions to help manage their overall process. Microsoft Excel is great and probably the most commonly used tool but it has its limitations.  Using a more sophisticated software solution gives you additional tools to grow the use of FMEA throughout your company. Leveraging parent-child relationships between FMEAs, the ability to report with a one click on Risk Priority Numbers (RPN), visualize defect nets and accessing libraries of data points gives you the edge in growing a foundation of thought leadership and lessons learned within your company.  Following an Automotive Industry Action Group (AIAG) approach utilizing both Design Failure Mode Effects Analysis (DFMEA) and Process Failure Mode Effects Analysis (PFMEA) referencing both is crucial for successful FMEA implementation.

Distributed versus Centralized Scanning: Making a Choice for Document Management

  
  
  
Centralized Scanning Blog

Scanning has become essential in the operation of practically all types of businesses, especially in view of the huge volume of documents each organization receives day after day. More and more businesses are implementing document management solutions, an important part of which is document scanning and storage. One of the questions business owners are faced with, where scanning is concerned, is that of which approach is better: distributed or centralized scanning? Here, we attempt to answer this question.

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