ASSURANCE Technologies, Inc.
Web Site: / ISO 17025 ACCREDITED
Hello everyone and thank you for coming this evening.
- For those of you who do not know me, I’m Kenn Losacco, President of Assurance Technologies, Inc. in Bartlett, Illinois. I have been the owner of ATI for a little over 20 years now.
- ATI has been in business, in the Chicago area since 1955.
- We Sell, Serviceand Calibrate Measuring & Testing Equipment for Manufacturers.
Before I get into my presentation, I would like to thank Hector Rodriguez for inviting me to speak here tonight.
I think that Hector & I have known each otherthrough the Quality Industry for most of my 20+ years.
Luckily for all of you, Hector has me limited to a set time for this presentation.
- Just Like at the Oscars,Hector has promised to start playing music if I go too long.
- So…, please be courteous to the other attendees. Write down any specific questions you may have on the handouts and save them for after the presentation. We will be answering specific questions at theQ&A stations at the back of the room if there is a little time before dinner and after the presentation.
My presentation tonight will be on “Managing Your Company Calibration Program”.
- My goal tonight is to give you a little better understanding of Calibration.
- Basically, how it came about, why it is needed, what you need to do and what you should be getting from your Calibration Provider.
In addition to my presentation tonight, we also have (2) Question & Answer stations set up in the hall for “A LITTLE BIT BEFORE DINNER & AFTER THE PRESENTATION”.
- This station over here, has employees from ATI who are here to answer any “specific” Calibration questions that you may have.
- And…, this station over here, has a demonstration of ATI’s A-Trax Gage Management Software that is accessed through our website. A-Trax is set up for free for all customers to make your Calibration Program “Pain Free”. It basically handles your GageControl Program for you.
- A-Trax will notify youwhenyour gages are due and send you a preprinted packing list to send your gages in.
- It will also allow you 24/7 access to all your calibration records.
- And provide you reports after a calibration alerting you to any failed conditions that were found.
Show Gage Block & Caliper for Demonstration
The definition of Calibration is:
The comparison of measurement values from a device under test (such as this caliper), against those of a calibration standard of known accuracy (such as this Gage Block).
- The calibration standard can be either a physical artifact (such as a Gage Block) or a generated value (such a Voltage as in Electronics).
Interesting enough, no one really knows where the actual word “Calibration” came from.
- It is suspected that it came from the word “caliber” (as in guns and cannons).
- It is thought that because soldiers probably didn’t like their cannon balls and musket balls getting stuck in the barrel of their weapons, causing the weapons to explode, they came up with “calibration” to insure the size of the projectile and gun barrel were within the “dimensional specifications” of the “caliber” of the weapon.
Dating back to the 1960’s, MIL-STD 45662 was probably the earliest standard to define proper calibration practices and was usually referenced in any Military related work.
- The Military eventually determined that there was a fairly high cost associated with creating and maintaining their own standards, so in many cases, they started referring to International Standards that were already available.
- In 1992,MIL-STD 45662 was replaced by ISO 10012 (Requirements for Measurement Processes & Measuring Equipment) which became the next referenced standard for most Military work. “ISO” stands for “International Organization for Standardization”
- In 1994, ISO 10012 was then replaced by ANSI Z540 (Requirements for the Calibration of Measuring & Test Equipment).
- Also released in the 1990’s, was ISO Guide 25 (Requirements for the Competence of Calibration and Testing Laboratories). In the late 1990’s, there was a big “Rush to become an Accredited Calibration Lab”, and this was really the first standard for Calibration Labs to follow and become accredited to.
- Finally in 1999, ISO 17025 was released and in 2000, it formally replaced ISO Guide 25. ISO 17 025 is the ISO Standard that is still being followed by Calibration & Testing Laboratories today.
As you can see, there wasn’t a lot of effort put into the requirements for Laboratories until the 1990’s. Then the requirements basically went crazy.
The ISO 9000 Quality Management System was probably the main reason for the emphasis. The ISO 9000 family of Standards was designed to help companies ensure they meet the needs of their customers as well as meeting all statutory and regulatory requirements.
There are many spinoff standards that use ISO 9000 as a basis, but also contain some additional specifics to certain industries.
- TS 16949 is ISO 9000 for Automotive Suppliers
- AS 9000 is ISO 9000 for Aerospace Suppliers
- ISO 17025 is ISO 9000 for Calibration and Testing Laboratories
Standardized Gage Calibration Programs have been in place for certain industries (like Aerospace & Military) for quite a while.
- In 1987, when ISO 9000 was originally released, the standard initially stated that a company “should” have a Calibration Program.
- In 1994, the original Automotive Quality Standard for all Automotive Suppliers, QS-9000 was released and it required all Calibration to be performed only by an Accredited Calibration Lab.
- QS-9000 and now TS-16949 were developed by a joint venture of the “Big 3 Auto Manufacturers” named AIAG. AIAG was an acronym for (Automotive Industry Action Group).
There were (3) main reasons why QS9000 was developed by “the Big 3”:
- To insure better quality parts coming from their suppliers.
- As a Cost Savings, to force the cost of Quality on the supplier.
- Like the Military, to eliminate the high cost of developing and maintaining their own standards.
- Unfortunately, in 1994, when QS 9000 was initially released, there were only (2) Accrediting Bodies (A2LA & NAVLAP) that could accredit Calibration Labs to the ISO Guide 25 &ANSI Z540 standards.
- And more unfortunately…, there were literally tens of thousands of automotive suppliers that were required to become Accredited to the QS 9000 Standard to continue to be an Automotive Supplier. Unfortunately, they couldn’t because QS 9000 required them to only use an Accredited Calibration Lab to perform their calibrations and there were only a handful in existence at the time.
- It was great for the only (2) Accrediting Bodies, A2LA & NAVLAP, but not too great for the Automotive Suppliers.
- Eventually, reality set in, and the AIAG gave a 2 year reprieve to the requirement until other Accrediting Bodies could be brought on board to accredit Calibration Labs to handle the load.
- This is also why people initially would ask if you were “A2LA Accredited” instead of are you ISO or ANSI Accredited. Kind of like asking for Kleenex vs Facial Tissue.
From there, it just became a “good practice” for most companies to follow along with accredited calibration programs. Mainly, because a company’s self-blessed calibration program is usually a real easy target for customer and ISO auditors.
From a Legal Standpoint:
- If your company ends up in a lawsuit and you have had your gages calibrated on a regular frequency by an outside company that is Accredited by an Accrediting Body that is Accredited through an International Organization, you have (3) levels of testing and checking in place to eliminate your Calibration Program as a potential contributor to a problem.
- What do returns and scrap cost you?
- What does it do to your reputation and can it result in lost customers?
- More and more companies that purchase parts have tracking systems in place to provide a “score” for on-time delivery and quality issues. If you want to continue supplying or get more business, you need to maintain a good score.
- Also many industries now have lengthy Corrective Action Processes that are required to be completed due to non-conforming material. The Corrective Action can also be followed up by a Customer Audit.
Good Example to Employees:
- If employees see you bring in a company from the outside, instead of having “Bob from Shipping” make an attempt at calibration, it shows your employees that you are “invested in Quality” and you stand a much better chance of them following your lead.
- - It Happens:
- Gone are the days of Journeymen Tool & Die Makers who went to night school, honed their skills for years as Apprentices and always checked their gage before using.
- Now, fewer and fewer people know how to properly use a gage, let alone how to properly verify it before using it. If that gage wears or is dropped, it can be measuring improperly and accepting bad parts.
It is always a good practice to train your people on proper use and verification of their gages as well as having them verify your commonly used gages on some reasonable frequency (say every Monday morning) and keeping a log of the measurements.
- Probably, the best example of how regular calibration has made an impact on an industry would be the Automotive Industry.
- When I was growing up, a car lasted 50,000 miles. After that, it was typically considered a “$500 beater”. Today, 100,000 miles is considered a car’s half life and that “beater” mark is now 250,000 miles or more.
- This is mainly because parts can be manufactured more accurately because they can be measured more accurately. When some Precision Machine Shops call us to purchase Measurement Equipment, I am truly amazed at what tolerances they are required to hold on their parts.
This concludes my Pre-Dinner presentation. We have briefly touched on a little history and few reasons why we calibrate.
Please enjoy your dinner. You welcome to visit the (2) tables until dinner comes out with any questions and after dinner we will continue with the program.
I hope you enjoyed your dinner.
I will try to keep this next part of the presentation to 1 hour, and more importantly, when speaking about the “exciting world of Calibration”, I will try to not put you to sleep.
OVER THE NEXT HOUR, WE WILL BE GOING OVER THE ABOVE TOPICS:
CHANGES AND INCREASED REQUIREMENTS WITHIN THE QUALITY INDUSTRY
- Requirements are always changing within the area of Calibration and the Written Standards for Calibration get revised about every 5 to 10 years.
- The ISO 17025 Standard that Calibration Labs follow is broken up into 2 parts:
“Management Requirements” and “Technical Requirements”.
The “Management Requirements” are mostly the same as ISO 9001, so any changes to ISO 9001 are also part of the next revision of ISO 17025.
UNCERTAINTIES OF MEASUREMENTS
“Uncertainties of Measurements” was a big push a couple years back by all the Auditors and seemed to be pushed by the International Accrediting Bodies that accredit the National Auditors.
“Uncertainty” is the Tested and Calculated Error found in each measurement a Calibration Lab makes. The better the methods a Lab has in place, the better trained the Tech’s are, and the better the grade of standards they use, the lower their Uncertainty of that Measurement.
IMAGE 1 –If I were to pass a tennis ball and a ruler around the room and asked everyone to measure the tennis ball with a ruler, because the ball is round and the ruler is flat, we would get many different measurements. This is a big exaggeration, but true to a certain degree with any measurement.
IMAGE 2 –This shows the TRUE VALUE, MEASURED VALUE, ERROR & CALCULATED UNCERTAINTY
IMAGE 3 –Shows a Pyramid of Error from NIST all the way to the Inspection of the Production Part
which is (1.161%)
Originally, the Auditors were OK with labs defining their Uncertainty of Measurements as a General Value called “Best Measurement Condition”. This was what your Uncertainty was under the best conditions.
They have since changed to wanting to see every Calibration Lab calculate the actual uncertainty of every measurement they perform in a calibration to include factors like the following:
- The Grade of standards that you used (EG: Grade 00, 0, 1, 2 Gage Blocks, all have different tolerances)
- Reproducibility & Repeatability of the Technicians and the procedures (G,R&R Studies). Basically (3) Tech’s make (10) measurements each and you see how Repeatable their measurements as individuals and how Reproducible their measurements between eachother.
- Independently run Interlab Proficiency Testing or ILPT’s thru NAPT, HN and other providers. In an ILPT, an artifact of know size, weight, etc. is sent to every Lab that joins the test. Each Lab’s results are matched against the known size of the artifact and against the other Lab’s results. If your results are not satisfactory, you must start a Corrective Action to correct the problem and achieve acceptable results.
- Environmental conditions (like fluctuations in temperature & humidity)
- On-Site vs Laboratory conditions, etc., all have to be defined and factored into a value as the uncertainty of each measurement.
It also created another Final Status of a Calibration – Besides “PASS & FAIL” There is now PASS WITHIN UNCERTAINTY (which we explain a little later in the presentation).
Unfortunately, in the beginning, the National Accrediting Bodies weren’t even sure what was an acceptable method for the International Accrediting Bodies and Re-Issuing of Accreditation Certificates for Calibration Labs that year took months.
THE HIERARCHY OF ACCREDITTATION
Within the ISO 17025 organization, there is no chance of a “Fox Watching the Hen House” in the world of Accredited Calibration Labs.
Every level of the ISO organization & the Accreditation process has a watchdog.
- International Accrediting Body Directing Committees
- The ISO/CASCO Committee directs the International Accrediting Bodies for Policy, Technical, Regulatory & Industry Input for any standard that is developed.
- International Accrediting Bodies
- Such as ILAC, APLAC, UKAS, & EA, Audit and Accredit the National Accrediting Bodies to
ISO 17011 (which is the International Standard for Competence and Ethics).
- National Accrediting Bodies
- Such as A2LA, NAVLAP, LAB, ANAB, PJLA, then audit and certify the Calibration Labs like “ATI” to ISO 17025 and other more specific standards.
ACCREDITATION SPECIFICS THAT YOU SHOULD BE LOOKING FOR IN A CALIBRATION PROVIDER
If you decide to start using or switch your Calibration Provider, you need one that you can trust and have confidence in. Your choice of Calibration Providers can mean the difference between passing your audits easily or having audits being a very stressful time in your job.
On several instances, we have been called by companies that decided to try another Calibration Lab to come and recalibrate devices that were already just calibrated by another Calibration Lab. Mainly due to their own internal auditors finding numerous errors and issues with documentation leading to eventual concerns of their actual capabilities.
But…, “the good news is that the Bad Calibration Lab was less expensive”.
- Is the Calibration Lab that you use “Accredited”?
- Any Calibration Provider that is ISO 17025 Accredited should provide you their ISO Certificate along with their Scope of Accreditation. The Device that you want calibrated must be contained in their “Scope” for the calibration to be an ISO 17025 Accredited Calibration.
- Every legitimate ISO 17025 Accredited Calibration Certificate will contain (3) logos (The logo of the Calibration Provider, the logo of the National Accrediting Body such as A2LA, NAVLAP, LAB, ANAB, PJLA) & the logo of the International Accrediting Body (such as ILAC, APLAC, etc.).
- Is Your Calibration Lab Accredited by an Official Body?
Do your homework and research the credentials of whoever you chose.
- There are Calibration Companies that do not want to take the time, incur the expense or have anyone looking over their shoulder making sure that they follow the rules. Some have taken it as far as teaming up with other so called, Calibration Companies to accredit each other. They will include a logo of an Auditing Company that they created, but that Auditing Company is never audited or regulated and their accreditation is virtually meaningless.
- Once again, if a Calibration Provider is truly ISO 17025 Accredited, there will always be (3) logos on every certificate of calibration.
- Is the Calibration that you are provided Accredited?
Some Calibration Companies offer Accredited and Non-Accredited Calibrations. They will either not mention this at all when quoting or present this as a cost savings option.
- Usually, the real reason behind 2 levels of Calibrations being offered is that they have had numerous problems in the past passing their audits. (calibration certificates not completed properly, measurement errors, equipment was not calibrated to correct specifications, etc.)
- Certificates for Non-Accredited Calibrations do not have to be shown to an Auditor during an audit and can be completely incorrect and full of mistakes. You are basically paying for nothing and opening yourself up for major legal issues if ever sued.
- In my opinion, this practice should be banned by the Accreditors for Labs that are accredited. It causes issues for other labs that “always” just follow the rules and do it right.
- There are also “NIST Traceable Calibrations” which can be for a legitimate reason (like a very infrequent request) but also sometimes to just not follow the rules and incur the expense.