The Standard in Quality and
Environmental Consulting
Since 1985.
The Standard in Quality and
Environmental Consulting
Since 1985.
Warning - All Calibration Certificates are Not Created
Equal!
Keri
Luka
Does your company think that it has adequate evidence of calibration because it has official-looking calibration certificates neatly placed in calibration files? How closely have you looked at the external calibration records provided by manufacturers and contract calibration laboratories?
Buyer Beware!
Some equipment manufacturers are apparently selecting and calibrating a sample of equipment in a manufactured batch. If the sample equipment is within calibration, then the entire batch of manufactured equipment is issued calibration certificates. Unfortunately, Cavendish Scott Consultants frequently find companies that are unwittingly purchasing such equipment because they see the words certificate, conformity, or calibration in the catalogue narrative without first ensuring that the equipment has been individually calibrated to national or international standards.
Upon reviewing the manufacturer certificates, it's easy to see how they can be confusing because many of them look official and often have titles like "Certificate of Conformity" and "Certificate of Calibration." Often these certificates even include vague statements regarding the process of calibration by referencing Z540, ISO Guide 25 or even ISO 9000. However, if you look closely at these certificates, it is obvious that they are not valid calibration certificates since they do not include the references necessary to trace the calibration to national or international standards as required by ISO 9000 and data is not generally provided.
What can you do if you have such certificates stored in your files in support of your calibration system? Start by calling the distributor or manufacturer. Ask for copies of the calibration data, evidence of traceability to the national or international standard (this is a number) and the actual procedures used to perform the calibration. If such information can be provided, then you will have enough evidence to believe that the equipment was individually calibrated. If the information cannot be provided, then ask if you can return the equipment and purchase equipment with traceable calibration certificates. In the worst case scenario, you may need to segregate the equipment from use and send it to a contracted calibration company for re-calibration.
Review Outside Calibration Certificates!
Upon receipt of calibration services, companies should review the equipment to ensure that it was identified properly and matches the information provided on the calibration certificates. The certificates should be reviewed to ensure that the required information has been included on the documents as specified in their Purchasing Agreements.
All too often, companies completely rely on the certificates provided by contracted calibration companies without looking at the certificates with a critical eye. Don’t forget to verify the records that you receive from contracted calibration laboratories - it serves as your receiving inspection for the services rendered!
As you perform this record review, ask yourself some questions:
Ensure that Calibration Certificates are Available for Review!
Some companies are electing to allow contracted calibration companies to maintain their records of calibration for them. If your company utilizes this service and has minimal records on-site for your calibrated equipment, you should ensure that the calibration company can locate and provide all of the necessary calibration records at your request. Don't forget that some registrars will review calibration in the afternoon on the last day of the assessment. In such cases, your company may need access to their records in minutes. It would be a little more than disappointing to fail an assessment because the calibration records were not made available for review!
To ensure that the calibration company understands your expectations, ensure that your requirements are clearly stated on your purchasing agreements.
Don't forget to verify that the calibration company is able to provide you with the necessary records during internal quality audits by selecting a sample of the calibrated equipment, calling the calibration house, and asking for the corresponding records.
QS 9000 Calibration Companies and ISO Guide 25 - A New Requirement
While ringing in the New Year, QS 9000-certified companies are scratching their heads regarding their ability to locate ISO Guide 25-certified calibration companies so that they can remain in compliance with the standard.
If your company is trying to comply with QS 9000 you should be aware that the 3rd edition of the standard requires that external calibration companies be certified to ISO Guide 25 or a national equivalent. If you cannot locate a Guide 25-certified calibration company, then you need to try to locate a company that can provide evidence that they have been audited by an OEM customer or an OEM-approved second party and that they were found to meet the intent of ISO Guide 25.
Registrars have agreed that locating such calibration companies with the right credentials has been a problem but they are required to assess companies for compliance in spite of the difficulties.
An AIAG representative recently told Cavendish Scott that they have had a lot of complaints about the requirement because of the difficulty of locating such laboratories and the cost of sending inspection, measuring, and test equipment to laboratories in other states. The AIAG said that they are planning on publishing an official position on the requirement in the near future so keep an eye on their publication. That position has now been published as the official sanctioned interpretations of QS 9000. The new position is that the registrar need not enforce this requirement so long as the supplier has a plan in place, detailing how compliance can be achieved by Jan 1, 2001. That gives everyone a little more time to push those calibration sub-contractors to seek accreditation.
