We are having some problems with our phone system in the NC office today (again). If you are having trouble getting your call to go through please keep trying, or email us at massflow@mfchelp.com.
Tim Williams, Tasha Williams, Brad Darby, and Bob Williams at the Semicon West show in San Francisco.
All Coastal-US offices will be closed Monday, May 26, 2104.
After the fire in our facility in July 2011 we spent the next several months rebuilding our calibration lab in a temporary facility and reactivating our ISO 17025 accreditation. Due to the extensive damage incurred on our primary standard system, and the critical need to restore our ability to provide accredited calibrations as soon as possible, we chose to focus on restoring the accreditation of our transfer and working standards first. The ISO 17025 accreditation of our transfer and working standards in our temporary facility was reactivated in April 2012.
During the following year and a half we designed and constructed a new permanent calibration facility, moved into the new facility, and then performed the actions required to restore the accreditation of the working and transfer standards for the calibration systems as installed in the new facility.
Two years after the fire, we finally had the time to work on our primary standard system. Over the last several months we have completely redesigned our primary standard system with new state of the art proximity sensors, timers, pressure and temperature transducers, and developed enhanced operating software to control and monitor the whole system. After months of debug and fine tuning the operation of the system we have produced the data required to restore our accreditation for the primary standard system. We are proud to announce that as of today, April 25, 2014, we have received accreditation to ISO/IEC 17025:2005, and ANSI/NCSL Z540-1-1994 from the American Association for Laboratory Accreditation (A2LA) to add our completely redesigned and enhanced primary standard system to our scope of accreditation.
A lot of work from a lot of people went into fully recovering from the fire of almost three years ago. This was the last step. Great job by all!
If your internal quality system specifies that you use an ISO 17025 accredited calibration laboratory for your mass flow controller calibration needs, you are probably assuming all calibration laboratories accredited to that specification have the same capabilities. Accreditation to the ISO 17025 specification results in the issuance of an accreditation certificate, and a scope of accreditation, which lists the specific parameters covered by the accreditation (ie, gas flow), the type equipment used to make the measurement (ie, Bell prover primary standard), the full range of values (ie, 1 sccm to 1,000,000 sccm), and the calculated uncertainty of that specific measurement (ie, .27% of reading). Be aware, there is a significant, unstated gray area in the issuance of that certificate.
When the accredited laboratory undergoes the audit process the auditor covers only the services and capabilities claimed by that laboratory. If the laboratory claims they only take flow data, then the audit covers only the process and equipment used in taking flow data. It does not cover any other service, like disassembly/reassembly, cleaning, reconfiguration (range or gas change), repair, or the adjustment/recalibration of the device. This means that they cannot (OK, should not) issue you a certificate of calibration certified to the ISO specification if they performed any of those services as part of the calibration process because those processes have not been audited and the lab has not demonstrated competency in meeting the requirements of the ISO standard.
How do you know this? You do not! The scope of accreditation assumes that any processes or services claimed as part of the calibration process are included in the audit and by definition meet the ISO 17025 standard, but it does not define any of those capabilities other than generation of flow data. At this point this becomes an honor system. A system that says “if I tell the auditor I am doing it, I have been audited, if I do not tell them then I do not need to be audited”. You could ask your vendor if they are certified to ISO 17025 for the “repair and adjustment” of your device (good luck on that answer), but the only way you could know for sure would be to see the actual audit report from the accrediting body, which I doubt you are going to do.
Coastal Instruments, Inc. has been audited and accredited to ISO/IEC-17025:2005 and ANSI/NCSL Z540-1-1994, for all the services that we perform…. period. That includes the cleaning, replacement of parts, repair, adjustment, reconfiguration, and recalibration of your device. That audit process includes the procurement system for spare parts, tools, and the software used for the repair and reconfiguration, the process for disassembly, cleaning and reassembly, and the adjustment of the device after the “as found” data has been taken. Unfortunately our scope of accreditation only says we can generate accredited data on the device, just like everybody else that only takes data on a device. If your calibration vendor is performing any of these services as part of the accredited calibration, they should be able to prove they have been audited to do so. If you are getting “as found” and “as left” data, and they are different, then the vendor is performing adjustments which should be part of the audit process. If you are being charged for the repair or reconfiguration of your device as part of the accredited calibration process, that process should have been part of the audit. If they were not, the calibration certificate you have been issued is questionable, and you are not getting the protection of using an accredited vendor that you assume you will get, and that you should get.
It has been very frustrating for Coastal Instruments to make the effort we have made to comply with the full intent of the standard and yet nothing in our scope reflects this, nor is there any component of our certificate or scope of accreditation that will differentiate Coastal Instruments from the labs that can only take a set of data. We have petitioned the accrediting body to address this issue, and while they do agree that this is a significant gap in the accreditation process, there appears to be no short term solution. In the meantime, all we can do is bring attention to this issue and make the offer that any customer who would like to see our full audit report, which defines every system covered in the audit, can do so by contacting our Quality Manager. Will your current ISO 17025 vendor make that offer?
Well, it looks like we have another winter storm bearing down on the NC area tonight with freezing rain expected most of tonight and tomorrow. Our people went home early today and we expect that road conditions will not allow us to open the NC office on Wednesday, so if you try to call us you may get our voice machine with the number for the “on call” folks. Bear with us, we will be back open as soon as we can. In the meantime our AZ and OR offices are open as usual if you need an immediate response.
There was nothing on TV tonight except a program showcasing very cute and sometimes thought provoking commercials, obviously sponsored by the NFL, since they had a game going on between the commercials that you could sort of watch, unless you had to go to the bathroom, or the snack table before the commercials came back on. Anyway, I was surfing the web looking for deals and information on flow devices when I noticed how many flow service companies state they are ISO 17025 or some other number, compliant. A very few state they are ISO accredited, Coastal Instruments being one of those. What is the difference?
A company that claims to be ISO compliant is saying that they know what the number is, they might have a copy of the regulations, and they are sure they are doing everything by the book, or at least everything that was easy to do, because, well…… because they said so.
A company that is ISO accredited will ALWAYS list an accreditation certificate number, and usually the name of the approved accreditation company they used to certify their compliance to the specifications. These independent companies are certified to perform ISO accreditation audits that require a knowledgeable auditor(s) to spend several days on site verifying compliance to EVERY line item in the respective regulation and continuing follow up audits on a regular basis, by a different auditor each time. This is a very easy thing to check. Go to the web site of the accreditation company and see if the certificate is listed. If it is, they are, if it is not, they are not. This certificate will also state the specific parameters, range of values, the uncertainty of the measurement error, technology, or products that are included in the accreditation. Some companies use their accreditation for one parameter to infer they are accredited for others. If their certificate says they are accredited for pressure or voltage, etc. over a specific range of values, then that is all they are accredited to do. They may do any other service as they like, but it will not be under the accreditation to the ISO specification.
The overwhelming majority of the effort, and cost, to meet the requirements of an ISO regulation is the work required to develop, document, and implement the procedures prior to any attempt to become accredited.. If a company is truly ISO compliant, meaning they have all those systems in place, would it not make sense that they would expend the relatively small incremental effort and expense to gain accreditation?
Coastal Instruments, Inc. is accredited by the American Association of Laboratory Accreditation to ISO/IEC 17025:2005 & ANSI/NCSL Z540-1-1994, Certificate Number: 2235.01. Check it out yourself at http://www.a2la.org/scopepdf/2235-01.pdf. We are very proud of the effort it took to earn and maintain that certificate, and for the assurance of quality that it gives our customers.
Bottom line, if a company makes claims that they are compliant with an ISO regulation without offering any accreditation, they are most likely NOT. What else are they NOT doing to assure the quality of your product?
I think the commercial special is over now, I wonder if Swamp People is on?
Well, by now you have probably heard that we have some pretty unusual weather in the eastern NC area. We don’t see much snow and ice here and, when we do, it shuts everything down. As you can see from this pic of the highway to our office it is solid ice and we have asked our employees to stay home until the conditions are safe to drive. If you need assistance before we get back in the office we have phone numbers on our message machine that you can use to contact our on-call people. Also our AZ and OR offices are working as usual so they can help you as well. We expect it will be Monday, 2/3/14, before we get our NC office back in full operation. Thanks for your patience.
We would like to welcome the newest member of the Coastal Instruments, Inc. team, Josh Trillizio, who has joined us in our North Carolina office as Information Technology Technician. We will probably cook something to celebrate, we usually do.
A big thank you to all of our employees for their continued commitment and hard work, and to our customers for entrusting us with their business in 2013. Happy New Year to all from Coastal Instruments, Inc..