Pin Gage Calibration Procedure - ISO 17025:2005 accreditation requirements?

[Bob the QE]

This may be a repeat of another question or a different flavor of the question but here it goes. To set the situation up we use pin gages and have them calibrated in sets, like most folks. The agreement between us and our calibration facility was that if pins were missing then the sets were to be held until the pins were ordered and received. The set would then be returned to us in full and calibrated. This was not happening, when questioned as to why I am told it was an "oversight" by office personnel. My question is under ISO9K:2K or AS9100 I would expect that there would be a work instruction or process details that would call this out as it is our (customers) requirement. Being they have many customers with different needs I would look at it as product/service specific so it should be a work instruction but I could live with a procedure. This is what I will be going after them for as they are ISO9K:2K and ISO/IEC 17025:2005 accredited. My question is to the ISO/EC accreditation, is there any thing in that standard that would be applicable to this situation.

Your comments, thoughts and ideas are always welcomed

 

[JAltmann]

Re: Pin Gage Calibration Procedure - ISO/EC accreditation requirements?

What does your contract with the calibration company state? That would be the only binding document. ISO-17025:XXXX like ISO:9000 does not get into those kinds of specifics.

 

[Frank T.]

Re: Pin Gage Calibration Procedure - ISO/EC accreditation requirements?

What does your contract with the calibration company state? That would be the only binding document. ISO-17025:XXXX like ISO:9000 does not get into those kinds of specifics.

If I remember correctly, what JAltmann mentioned about is correct.

Even though ISO 17025:2005 includes ISO 9001, the calibration lab doesn't necessarily have to be evaluated against the requirements of ISO 9001 to be accredited to ISO 17025. Therefore unless stated in the contract, your agreement for them to hold the gage pins, may not be binding.

Note: I don't currently have the standard in front of me; I'm going from memory.

 

[Bob the QE]

Re: Pin Gage Calibration Procedure - 17025:2005 accreditation requirements?

Now I am confused, am I to understand that the calibration standard ISO-17025 does not have things such as doc controls, cust requirement standards or the like in it. If I understood JAltmann post, I don't totaly agree with it but that is probably my fault. The part I would not agree with is that customer requirements must be in the contract. If that was the point, if not I miss read. Some delivery requirement may on prints or inside other standards or have been communicated verbaly. ISO9K:2K says is that delivery activities need to be determined (7.2.1) and in 7.5.1 f) delivery requirements are called to be controlled. Being the person who replied with the response it was an oversight was part of that chain ( which I failed to explain ) I feel that these two points are still valid. I am just so unsure as to the scope of 17025.

Thanks for the input.

 

[Frank T.]

Re: Pin Gage Calibration Procedure - 17025:2005 accreditation requirements?

The ISO 17025 standard itself is comprised of 5 elements:

1. Scope
2. Normative References
3. Terms and Definitions
4. Management Requirements
5. Technical Requirements

Elements 4 and 5 contain the actual accreditation requirements.

4. Management Requirements
- Organization
- Quality system
- Document control
- Review of requests, tenders and contracts

What is the difference between a request, a tender and a contract?

Requests, tenders and contracts are three different activities. Initially, a request is received from the client for a scope of work. The lab, in response, makes a tender (proposal) to the client. The tender may include clarifications to the scope of work, scheduling information, monetary compensation, etc. A contract is the agreement between the client and the lab. The standard requires a review and record (per Section 4.4.2) of all three phases of the process.

- Subcontracting of tests and calibrations
- Purchasing services and supplies
- Service to client
- Complaints
- Control of nonconforming testing and/or calibration work
- Corrective action
- Preventive action
- Control of records
- Internal audits
- Management reviews

5. Technical Requirements
- General
- Personnel - Accommodation and environmental conditions
- Test and calibration methods and method validation
- Equipment
- Measurement traceability
- Sampling
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting the results

 

[Hershal]

Re: Pin Gage Calibration Procedure - 17025:2005 accreditation requirements?

Actually, ANS/ISO/IEC 17025:2005 Clause 4.4 (Review of Requests, Tenders, and Contracts) requires the cal lab to detail such requirements. Thus, if your contract requires them to hold the pins and they accept the contract, then they are bound. The request must be reviewed, the Management must determine that the lab has the ability and resources to meet the requirements, records must be maintained, and any amendments go through the same process and be communicated to affected parties.

As for procedures, there is more than one Clause that addresses procedures, such as 4.3 and 5.4, including validation. Records are addressed in numerous places, including 4.13 and electronic infrastructure in at least four places.

Also, if this is a departure from the contractual agreement, then Clause 4.9 Control of Non-Conforming Work and 4.11 Non-Conformance may also be required. This can be easily communicated under Clause 4.8 Complaints, and the lab needs to follow up to see if you become happy under the requirements of Clause 4.7.2 which deals with Customer Feedback.

As to "oversight" by office staff, they are people and make mistakes. Hence, the first question is regarding communication of the requirements, which is addressed in numerous sub-Clauses of 4.2 and 4.3, and those are requirements placed on lab management to assure.

ANS/ISO/IEC 17025 is a tough Standard and labs go through assessments not just of docs and procedures; that is a part of it - but ONLY a part.....the technical proficiency (known as Competence) is equally important, if not more so.

This may be a simple issue, if so, work with the lab to fix it and move on with life. If it is systemic then other remedies are available.

Hope this helps.

 

[Bob the QE]

Thanks for the input, many valuable and point on observations. In order to stick to just one part of the problem.
I am now in an arm wrestling match on the issue of pin gages and traceability. I will attempt to be as consice and clear on the problem the situation is this: We have pin gage sets that get calibrated once a year. Each facility only has one set per facility so there are not multiple set of the same sizes. Since the policy of holding incomplete sets until they were made complete WAS NOT FOLLOWED people ordered "missing pins" to keep production going. So on my latest attempt to rectify this I took one set, one size range (.011"-.250") and sent it out and have all mising pins replaced, the set calibrated and a cert provided. When I received the set back I put it out on the floor and you can guess what came next....I have 3 .125" pins:mg:My stance is that we are in a world of hurt on our next audit, which will be an ISO surveillance, we may get a pass if the situation is not discovered and/or I have a contigency plan for the next audit in my corrective action syste. However, as we begin our final push for AS registration I see this being a bigger and more seriouse situation. So to all my auditor friends put your audit cap's on and answer me this. With just the info I supplied you, could you make a finding? Here is a little more information, no pins are identifiable to a set except that we only (or were suppose to) have one set of each size. So if you find 2 .125" pins I could not tell you which one is "really" from that set or cert

Thanks for all the feedback

 

[Southern Girl]

An auditor will look at your procedures, work instructions, etc., and assess compliance to them. If you have a "document" that states you will only have one calibrated set of pin gages per facility and the auditor finds evidence of multiple sets (individuals or complete), then you are NOT compliant with your own document. The other evidence obtained during this audit will determine if a finding is issued or just an observation. Remember, any evidence of your company not following its own procedures will apply here as well. What you have is not just calibration or gage related. This is could be a systemic issue applied across all departments. Do not confuse the specific requirements within a document as being the only auditable item.

I guess the best rule is this. Make sure that your documents state what the process is suppose to look like and then train everyone to those documents. Say what you do and do what you say.

 

[Jim Wynne]

Thanks for the input, many valuable and point on observations. In order to stick to just one part of the problem.
I am now in an arm wrestling match on the issue of pin gages and traceability. I will attempt to be as consice and clear on the problem the situation is this: We have pin gage sets that get calibrated once a year. Each facility only has one set per facility so there are not multiple set of the same sizes. Since the policy of holding incomplete sets until they were made complete WAS NOT FOLLOWED people ordered "missing pins" to keep production going. So on my latest attempt to rectify this I took one set, one size range (.011"-.250") and sent it out and have all mising pins replaced, the set calibrated and a cert provided. When I received the set back I put it out on the floor and you can guess what came next....I have 3 .125" pins:mg:My stance is that we are in a world of hurt on our next audit, which will be an ISO surveillance, we may get a pass if the situation is not discovered and/or I have a contigency plan for the next audit in my corrective action syste. However, as we begin our final push for AS registration I see this being a bigger and more seriouse situation. So to all my auditor friends put your audit cap's on and answer me this. With just the info I supplied you, could you make a finding? Here is a little more information, no pins are identifiable to a set except that we only (or were suppose to) have one set of each size. So if you find 2 .125" pins I could not tell you which one is "really" from that set or cert

Thanks for all the feedback

You have a gage control issue. The only way to control pins is to control them--don't put sets out on the floor, issue them as they're needed and make sure they're returned when the job is finished.