Are you aware of the requirements to generate a calibration certificates?

One of the very first things to have during the start of any calibration activity is to prepare the necessary documents like calibration methods, forms, and work instructions in order to record and document the performed job order. These are the measurement related records.

And prior to this, we are instructed to execute any customer requirements and guided by the rules as per the standard document (ISO 17025 standard).

Recording as part of our documentation is not a new activity. I believe that most of you that are engaged in this technical field are doing some kind of documentation or recording of results as part of your daily job activity.

In this post, I will present with you the following:
1. technical records that we need during calibration,
2. the reason why we need to record calibration results,
3. what to include in the calibration technical record,
4. the right way to amend a record as per ISO 17025: 2017 and which is also applicable to ISO 9001:2015 calibration management.
5. the clause under ISO 17025:2017 and ISO 9001:2015 related to technical records

I also discuss the lists of calibration documents which include the form that we need to have in order to maintain compliance with the requirements of ISO 17025 Standards including ISO 9001:2015 calibration requirements.

The Need for Technical Documentation in Calibration

Are you familiar with the statement “If it is not recorded then it is not calibrated”?

I do not remember who wrote that (you can comment it below). Based on the quality standard today in every industry, the above statement is very true.

As per my experience, the majority of calibration activities consist of 60% documentation and only 40% calibration (the technical aspect). There is more work performed in documentation compared to executing the actual calibration of instruments
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Below is also some guide questions why we need to “Have” and ‘’Maintain’’ documents (form) and Technical Records in Calibration Documentation requirements:

• How can you accomplish your calibration execution thorough and faster?
• Do you know exactly what to check or verify during calibration?
• When performing calibration, do you sometimes forget other requirements of the procedure?
• How do you know that you followed the requirements of your customer during calibration?
• How can you repeat the same procedure all over again and avoid missing important calibration data?
• If some problems during reporting or recording are encountered, how can you directly determine the person who performed the calibration?

Simple advice, if you are starting to enter this field and you do not want too much documentation as part of work, then this is not a job for you.

But of course, there are still some exceptions that depend on the design of your calibration process, but in general, this will apply (more so if you are performing under quality department)

Problems You Will Encounter If You Do Not Have Sufficient Calibration Records or Technical Records.

1. If Calibration procedure is not recorded and standardize, anyone has its own way of doing things which will result in more inaccurate and inconsistent results
2. Without calibration records, you will not have data to review for any mistakes and corrections that can be used for future improvements.
3. No records mean no work done resulting in a non-compliance during an audit.
4. You will face the issue of traceability in the documentation. There is no way to backtrack your results to correct any issue related to reported results.

Technical Records Requirements as per ISO 17025:2017

ISO 17025 is an International Standards design to promote confidence in the operation of Calibration and Testing Laboratories. Its requirements on calibration records under Clause 7.5, Technical Records, which states that:

7.5.1 The laboratory shall ensure that technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original.

The technical records shall include the date and the identity of personnel responsible for each laboratory activity and for checking data and results. Original observations, data, and calculations shall be recorded at the time they are made and shall be identifiable with the specific task.

What are these Results, Reports and Sufficient Information?

In order to repeat the procedure when required and to establish traceability, the contents of the records shall include below (at least)

• Date of calibration or testing;
• Identity of the personnel responsible for the record;
• Description of the UUT/ UUC (Unit Under Test or Unit Under Calibration)
• Description of the reference standard;
• Environmental conditions;
• The Test of Calibration Procedure used;
• Original observations, data, and calculations;
• Results like: as-found/as-left results, calibration,  and uncertainty results

Reporting of results follows the requirements of a calibration report or certificate and other required information.

>> please check out the complete requirements of calibration report  here in my other post: How to Properly Use and Interpret an ISO 17025 Calibration Certificate

If ever there is an amendment or  corrections to be made, Clause 7.5.2 states that, both the original and amended data and files shall be retained and must include:

1. the date of alteration or amendments,
2. an indication of the altered aspects or mistakes
3. the personnel responsible for the alterations

This means that there should be no hard erasures, a cross-out/ strikethrough is enough to cover the mistakes then a signature with date and the correct term alongside the mistakes is enough.

What are the Benefits of Using Forms and Maintaining Calibration Technical Records?

It is obvious that we need to record as per requirement but the following are some  reasons why we need to create and maintain a technical record:

1. This is the main reason under ISO 17025:
   1. Clause 7.5.1 states that “ to enable the repetition of the laboratory activity under conditions as close as possible to the original”.
   2. Clause 7.5.2 stated as, “ to ensure that amendments to technical records can be tracked to previous versions or to original observations”.
      
      
2. Evidence that we perform the required calibration job as per the procedure.
   
   
3. To make your calibration results traceable.
   This means that to backtrack the person who performs the calibration including other factors that have an effect on the work done. Related to number 6 below on Measurement Traceability.
   
   
4. Evidence of conformance to the standards (ISO 17025 or ISO 9001 calibration requirements) and processes during audits. Technical records are used as an answer (or evidence) to most of the audit questions.
   
   
5. Evidence that we follow the procedures or requirements completely through the data results that we record and report. Not all information is reported in the calibration report, therefore, this serves as our back-up.
   
   
6. A requirement for the Standard ISO 9001:2015 under Monitoring and Measuring Resources
   • under clause 7.1.5.1 which states that “The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources”.
   • under clause 7.1.5.2 on Measurement Traceability which states: “The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose and shall take appropriate action as necessary.”

——— This means that:

a. We need to maintain technical records as evidence of documenting the valid results of our measurements during monitoring.

b. We need to maintain records in order to traceback any issues concerning the effect of measuring equipment found to be out of tolerance that is used on a certain product in order to take appropriate action. This is where we can review past results for validation purposes in case an issue related to the calibration or measurement process is suspected.

How Long Can We Retain Calibration Records?

One way to control records is to keep them for a designated period. The recommended retention period for technical records in calibration or testing is at least 4 years. Be sure that it is documented under the control of records procedure.

A longer storage period for calibration records is required because some records are needed during performance review or history of data to be used during quality control.

This is also a requirement of regulatory bodies that we need to follow.

What are the Necessary Forms and Records That We Always Need to Perform Calibration?

Please do not get confused about the differences between a form and a record. Forms and records are not the same. A form is a blank document designed to guide and make a specific activity more organize and mostly much faster. While a record is a filled-up form or a form where the required data is already written in the provided space.

Forms are always the best tool to use in documenting or recording your accomplished work. Forms should always be a part of every calibration procedure.

Having a form to fill up with will provide a better and faster flow of calibration execution. It is a calibration template that will guide and show you what to do next. Just fill in the blanks.

The following are a list of forms and records that we need to have while performing calibration:

• Forms for recording Calibration data – we call it  Measurement Data Sheet (MDS) (others call it Measurement Data Result or worksheet) – below are its purpose:
  1. it contains all data recording of calibration results and observation –
  2. This will guide you on what information we need to record.
  3. It summarizes the calibration procedure to avoid missing out some requirements
  4. This serves as a draft for review and approval

• Accomplished Forms or a record of Customer requirements (if available) – to determine the specific requirements of the customers

• Calibration procedure – the exact procedure to be used, this will be reflected in the final report.

• Manufacturer Manual – a guide for proper operation and a source for accuracy requirements for verification.

• Uncertainty Budget Template – for easy calculation of measurement uncertainty.

• Calibration report template – a form where the final output from the MDS will be reported and to be printed as the final calibration certificate.

• Calibration report of the reference standard used – to determine the exact data for calculation of results.

In this time where technology are advancing, forms does not necessarily in a hard format or copy. Depending on the resources of the lab, forms can be in an electronic format.

Just remember, all these documents must be controlled in any way possible or monitored for any changes and distribution.

Conclusion

One of the requirements for every documentation and Standard is to maintain a record. I have discussed in this post the importance of maintaining technical records, what are the technical records in relation to calibration execution, the forms we need during calibration and the related clause about technical records according to ISO 17025:2017 and ISO 9001:2015.

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Best Regards,

Edwin