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Alliance Calibration

FDA 483 Letters: 2nd Quarter 2016 Update

Posted by Phil Wiseman on Aug 9, 2016 3:16:39 PM

You've got Mail!

Well, you really don't want to get this letter from the FDA. The title of the web page says it all:

Inspections, Compliance, Enforcement, and Criminal Investigations.

FDA 483 letters are public records and can be viewed by anyone.

We have reviewed the 2nd quarter 2016 FDA 483 letters issued and see some trends in calibration that you should avoid.

Issuing offices include New York, Baltimore, Kansas City, Dallas, Philadelphia, New jers and, Seattle.

While public records, letters were redacted to remove company names and processes.

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Topics: Standards and Compliance

How Do I Know If My Lab is Capable?

Posted by Phil Wiseman on Jul 28, 2016 3:20:09 PM

Select an ISO 17025 accredited Lab and leave it at that.

This is the approach taken by many consumers of calibration services.

Continue reading to learn why this is not the best approach in selecting calibration services.

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Topics: Standards and Compliance

Pigs get Fat. Hogs get Slaughtered. The need for transparency in Business today.

Posted by Phil Wiseman on May 31, 2016 12:57:26 PM

Mark Cuban, owner of the Dallas Mavericks was recently quoted by ESPN -"I think the NFL is 10 years away from an implosion."  "I'm just telling you: Pigs get fat, hogs get slaughtered. ."

"Just watch. Pigs get fat, hogs get slaughtered. When you try to take it too far, people turn the other way. I'm just telling you, when you've got a good thing and you get greedy, it always, always, always, always, always turns on you. That's rule No. 1 of business."

429 companies on the 1955 Fortune 500 list are no longer on that list.

Have you heard of Netflix?

Rhetorical question.

You think Blockbuster Video should have purchased them when they had the chance?

Blockbuster who?

Want a more extensive list?

Visit 10 businesses that failed to adapt.

Name a company that has been dominant for last 25 years?

U.S. News & World Report in their article 10 Great Companies that Lost their Edge articulates several companies that remain significant and the many that have become irrelevant.



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FDA 483 Letters: 1st Quarter 2016 Update

Posted by Phil Wiseman on May 27, 2016 7:30:00 AM

You've got Mail!

Well, you really don't want to get this letter from the FDA. The title of the web page says it all:

Inspections, Compliance, Enforcement, and Criminal Investigations.

FDA 483 letters are public records and can be viewed by anyone.

We have reviewed the 1st quarter 2016 FDA 483 letters issued and see some trends in calibration that you should avoid. While public records, letters were redacted to remove company names and processes.

Read More

Topics: Standards and Compliance

20 hours or 10,000 hours: What does it take to become a Subject Matter Expert.

Posted by Phil Wiseman on May 23, 2016 10:19:03 AM

In the past 3 years I have achieved 6 professional certifications. That is more than I accomplished in the previous 10 years. Being the curious person that I am, I began to wonder what does it really take to be an expert?

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Topics: General Interest Geek Stuff

Trust: Does it still exist?

Posted by Phil Wiseman on May 5, 2016 8:45:07 AM

There have been some major recalls in the news of late. Google recalls and you will get 117,000,000 results in under 0.32 seconds.

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Topics: Standards and Compliance

FSMA(Food Safety Modernization Act) and Calibration

Posted by Phil Wiseman on Mar 28, 2016 9:00:00 AM

 

From the FDA-
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Topics: Standards and Compliance

ISO 9001:2015- Is your calibration program ready?

Posted by Phil Wiseman on Mar 18, 2016 9:33:43 PM

Recently I was in a discussion with several Quality Managers regarding ISO 9001:2016 and the focus on Risk. 

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Topics: Standards and Compliance

AMS 2750E and Measurement Uncertainity

Posted by Kevin Radzik on Mar 10, 2016 1:08:27 PM

AMS2750E and a Complete lack of Measurement Uncertainty.

Section 2.2.75 of AMS2750E defines “Traceable” (or Traceability) as “The ability to relate measurement results through an unbroken chain of calibration to NIST or equivalent agencies in countries outside of the United States.”


In the expansive and varied world of calibration we have a dictionary. We call it the VIM (JCGM 200:201 International Vocabulary of Metrology) Section 2.41 (6.10) defines “Metrological Traceability” property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. This definition is followed by eight different notes to clarify the definition further and allow for special circumstances.

Download the VIM International Vocabulary of Metrology

None of those notes remove the requirement for measurement uncertainty.


To simplify all this, in the language of metrology and therefore calibration, you cannot have traceability without uncertainty.

This part is non-negotiable to metrologists and if you are dealing with an ISO/IEC 17025 accredited laboratory it is not just an NC- Non Conformance.

It is considered a complete breakdown in traceability, and that’s a big deal to us.

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Topics: Standards and Compliance

Cleaning out the Fence Row

Posted by Phil Wiseman on Feb 29, 2016 10:20:02 AM

Cleaning out the Fence Row and Data Management/Presentation

 

 Every year in late winter/early spring I look at the fence row in my back yard and realize it is time  to clean it out. The process is nearly identical every time. I start with large pruners and cut back  branches so I can get in between the fence and what I need to clean.  Once I have made a  "path",  I get out the chainsaw and cut down all the large unwanted growth that has  occurred since the  last time I cleaned the fence row. Then I make a brush pile for all the large  debris. Next I use  the  hand pruners to remove all the growth that has entangled itself in the  fence.

 Mission accomplished!

 Now I step back and look at my handy work and quite frankly I am always underwhelmed :(

 The fence row looks like it should.

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Topics: General Interest Geek Stuff

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Our goal is to provide information regarding calibration and its impact on your quality system.

In addition, we are the Geeks & Freaks of Calibration so we also post about Science for the nerd in all of us.

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