Quite often, we are asked about the most common deficiencies that are cited by assessors during A2LA assessments to ISO/IEC 17025:2005.
The following is a list of the top ten deficiencies (#1 being the most commonly cited) for electrical testing laboratories that were assessed to the requirements of ISO/IEC 17025:2005 by A2LA assessors. The one-year period covered in this representation is from January 1, 2015 through December 31, 2015. There were 209 electrical testing laboratory assessments during this period, in which 1,288 deficiencies were cited in the ten areas listed below. Each deficiency reference is followed by examples of typical findings reported. Additionally, examples of root causes and corrective actions that have been submitted are provided to show how the deficiencies were satisfied.
Clause 5.2: This clause deals with the records, experience, and performance of laboratory personnel. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 5.2 include:
- There were no test authorization records in place for a technician;
- The laboratory has not defined the requirements of a trained and qualified Internal Auditor; and
- A recently hired technician was listed as “in training” yet was performing tests in the laboratory without supervision.
These types of findings do not necessarily suggest that a laboratory or its personnel are incompetent to perform a particular duty; rather, the lack of updated authorization records or the inability to produce these records at the time of the assessment are typically found to be at the root of these deficiencies. Corrective actions typically include locating and providing the information that was missing or unavailable at the time of the assessment, or conducting the needed training for relevant personnel and providing evidence of the completed training event.
Clause 4.13: This clause deals with the mechanism by which laboratories control records. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 4.13 include:
- Records were found with illegible or crossed out information;
- Alterations to records were not signed (or initialed) by the individual making the change;
- Records were not retained per established timeframes; and
- There was no procedure in place for identification, collection, indexing, storage, maintenance, or disposal of quality and technical records.
These deficiencies often result from inadequate training or lack of oversight of relevant personnel and are generally corrected with new or refresher training, as applicable. Occasionally, the appropriate procedure may require an update to capture or expand upon the requirement, resulting in additional training for laboratory personnel involved in the control of records.
Clause 5.4: This clause deals, in part, with the laboratory’s selection and validation of test methods. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 5.4 include:
- An internal procedure was not validated prior to use; and
- Data was stored in such a manner that protection and confidentiality of information was not ensured.
These deficiencies often result from a misunderstanding by laboratory personnel or an oversight regarding the proper implementation of this section of ISO/IEC 17025. The manner in which the laboratory addresses the clause may be revisited to ensure thorough validation of internally-developed methods and additional safeguards may be implemented to ensure that data is stored in a confidential manner.
Clause 5.9: This clause deals with assuring the quality of test and calibration results. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 5.9 include:
- Data from quality control procedure implementation was not recorded in such a way that trends were detectable; and
- The laboratory did not participate in inter-laboratory comparisons, or applicable and available proficiency testing programs.
Often, laboratories are unaware of commercially-available proficiency testing programs that are relevant to the type of tests they perform or of the existence of appropriate inter-laboratory comparisons, which results in these types of deficiencies. In addition, although quality control data is usually captured, the laboratory may be unable to demonstrate how the data is used to detect trends. Minor adjustments to the relevant procedure are usually required to accommodate this aspect of the ISO/IEC 17025 requirement.
Clause 4.6: This clause deals with purchasing laboratory services and supplies. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 4.6 include:
- A supplier is being used that had not been evaluated;
- Records of suppliers and evaluations are not current; and
- There was no record that actions were taken to check compliance/appropriateness of purchased supplies/services upon receipt.
In many cases, laboratories utilize suppliers that have been used for years and so their fitness for use is based upon experience. Even so, this must be documented as the “evaluation” done of those suppliers. When supplies are ultimately received from a trusted source, laboratories may not be checking them upon receipt, due their lengthy relationship and positive experiences with the supplier. ISO/IEC 17025, however, requires this check of supplies, regardless of the source. Resolution of these types of deficiencies is often accomplished by reinforcing the requirements upon relevant staff.
A2LA Traceability Policy: Deficiencies cited against the A2LA Traceability Policy include the following:
- Specific equipment is not calibrated by an accredited provider (T1);
- The in-house calibration for specific equipment did not have a calibration report (T4); and
- The procedure for evaluating measurement uncertainty was not applied for specific equipment (T4).
Many root causes for A2LA Traceability Policy deficiencies originate from the laboratory’s desire to continue utilizing a calibration source that has been used in the past – even though the calibration source is not appropriately accredited. In order to ensure complete traceability of measurements, however, A2LA requires use of an accredited calibration provider. Laboratories are encouraged to fully review the A2LA Policy on Metrological Traceability (P102) to ensure compliance.
Clause 4.14: This clause deals with laboratory internal audits. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 4.14 include:
- Records were not available of the internal auditor’s training and qualifications;
- The most recent internal audit did not address testing activities; and
- The most recent internal audit did not address A2LA normative requirements (i.e. A2LA Advertising, Traceability, and Proficiency Testing policies).
Many deficiencies relating to this clause result from an incomplete understanding of what entails a full internal audit. For example, some laboratories feel that completing the A2LA general checklist for the ISO/IEC 17025 requirements is adequate. In reality, this is only one portion of a complete internal audit, as a check of the laboratory’s compliance with their own testing procedures and management system as well as compliance with A2LA policies and requirements must also be included. In addition, it is important to follow the pre-determined audit schedule, as deficiencies are frequently cited when laboratories postpone audit activities and thus fall out of compliance with their schedule.
Finally, although ISO/IEC 17025 does not specify what is considered adequate qualification for an internal auditor, the laboratory itself must determine what qualifications they expect and must then document how their internal auditor(s) meets those qualifications.
Clause 4.3: This clause deals with laboratory document control. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 4.3 include:
- The laboratory Master List of Controlled Documents is not up to date;
- An obsolete procedure is being used during testing; and
- Specific documents in the management system are not uniquely identified.
Many of these deficiencies result from the laboratory not following the document control procedure that is in place. For example, their document control procedure may specify that technical procedures are not to be kept at workstations but, rather, are to be referenced directly from a company intranet. If compliance with this aspect of the procedure is not enforced, then it is very likely that uncontrolled (and often obsolete) versions of procedures will begin to appear at technician workstations. Corrective actions for these types of deficiencies often involve more rigorous adherence to the laboratory’s document control procedure and may be accompanied by spot checks or audits to ensure continued compliance.
Clause 5.5: This clause deals with equipment which is used for accredited testing activities. Examples of deficiencies that have been cited against ISO/IEC 17025 Section 5.5 include:
- Equipment was not checked before being returned to service (after calibration, repair, or maintenance);
- Equipment was not uniquely identified;
- Equipment was not labelled to indicate the status of calibration; and
- There was no maintenance plan in place for the cited equipment.
These types of deficiencies often result from inadequate training of laboratory personnel or short-cuts being taken as a time-saving measure. Corrective actions frequently include retraining of relevant personnel and spot checks or audits to ensure continued compliance with the requirements.
Specific Criteria: This is a broad category that encompasses deficiencies that would generally not fall under ISO/IEC 17025:2005 clauses, but instead are cited directly against a test method. This can include issues with test setups, such as improper distances being maintained from the equipment under test to the walls of the surrounding structure, and also instances of improper demonstration of a test during the assessor’s observation. Other examples which were cited include bond resistance being greater than the test procedures allow, insulating support material in use exceeding the allowable thickness, and lack of proper site validation data.
The root cause for these issues is often related to personnel not referencing the test method on a regular basis (particularly for someone who has been doing this type of work for many years) and thus losing track over time of certain nuances or details within the method itself. Corrective actions for most of the cited “specific” deficiencies involve measures (such as retraining) to ensure that laboratory personnel are properly following the test method.
Occasionally, particular clauses of ISO/IEC 17025:2005 can be unclear or interpreted in a manner which is not intended. As such, A2LA has developed a list of explanations for various clauses to demonstrate how they will be applied by A2LA assessors. This listing may be found on www.A2LA.org by selecting “Explanations for the ISO/IEC 17025 Requirements” under the Documents drop-down tab. This list is updated as additional explanations are needed. Interestingly, most of the above clauses were also found in other one-year-period audits for electrical laboratory assessments. The repetitive nature of certain clauses being found as non-compliant suggests that additional clarity is needed. This further supports the necessity of this explanation resource provided by A2LA.
Ash Morton is an Accreditation Specialist for A2LA and assists in ensuring the quality and competence of A2LA-accredited organizations. He can be reached at 240.575.7487 or at amorton@A2LA.org.
Teresa C. Barnett is A2LA’s Senior Director of Quality & Communications and overseas the quality, marketing, sales, public training, human resources, IT and financial operations of the Association. She can be reached at 301.644.3202 or at tbarnett@A2LA.org.
Leave a Reply