2020

EXPERT ANSWERS

Metrology program 101

Q: How can an organizational metrology program be defined? What are its elements? How does the program affect the overall quality of an organization?

Waleed Al-Faris Sr.
Jeddah, Saudi Arabia

A: Metrology is the science of measurement. A strategy to initially define a metrology program would be to review general quality system standards and, subsequently, more detailed standards that specifically cover metrology. Next, you can apply the standards in the typical organizational document-structure hierarchy:

  1. Quality manual.
  2. Standard operating procedures (SOP).
  3. Work instructions.
  4. Forms.
  5. Records.

ISO 9001:2015 is a good place to start because it’s not industry specific. One of its stated quality management principles is the "process approach,"1 or seeing any process, such as metrology, as part of a system and interconnected with other processes. With this mindset, all sections of ISO 9001 apply to metrology in some way.

For example, leadership (section five) must ensure resources are available and all intended results are achieved. Planning (section six) requires addressing risks and opportunities. Support (section seven) further promotes the importance of identifying and applying the appropriate people, infrastructure and environment.

With respect to metrological terms, ISO 9001 subclause 7.1.5—"monitoring and measuring resources"—is specifically relevant. This subclause says the organization shall determine the resources—such as equipment, tools or personnel—needed to ensure valid and reliable results, and the resources are to be suitable and maintained. Measuring equipment also must be identified, calibrated or verified, and protected from adverse effects.

ISO 10012:2003 and ISO 17025:2005 can be used to outline the elements of a metrology program. ISO 10012 builds on the ISO 9001 process approach, stating, "Measurement processes should be considered as specific processes aiming to support the quality of products produced by the organization."2

ISO/IEC 17025 applies metrology principles within the framework of a laboratory.3 Consider your metrology program as a type of laboratory, and leverage all the good laboratory practices in ISO/IEC 17025. By starting with these standards and summarizing them, you can list 10 key elements of a metrology program:

  1. Establish the measurement management system (that is, the metrology program) as the "set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes."4 Determine where the metrology system fits into the quality system, determine inputs and outputs, define the organizational structure and responsibilities, and consider the appropriate environment.
    This becomes the "metrological function" described in ISO 10012. An important process that uses metrology is incoming, in-process and final inspections. Purchased products—including semi-finished and finished components, and manufactured goods—are involved. The ultimate goal is to determine whether quality meets specified requirements at all stages of a product’s realization.
  2. Document the measurement management system, linking the organization’s document structure to external standards. An SOP should be written, and it can be supported by specific work instructions that describe the use of each type of inspection, measuring and test equipment (IM&TE).
    Include all the elements I’ve outlined in this response, and determine which forms must be designed and controlled as part of the quality system. Think about what records must be maintained, such as calibration, preventive maintenance and test results.
  3. Define processes for identifying, purchasing and accepting IM&TE in the organization. Give each measuring device a unique identifier to facilitate control.
  4. Control the IM&TE. These procedures should outline IM&TE’s proper use and handling, how to read the device, care and cleaning, routine maintenance and confirmation.
  5. Metrological confirmation is foundational to the program. Confirmation is the "set of operations required to ensure that measuring equipment conforms to the requirements for its intended use."5 Calibration is one part of confirmation, but confirmation also includes all verifications that demonstrate the measuring device is adequate, including defining ranges of use, resolution, bias and measurement uncertainty. Procedures should be written for calibration, covering timing between calibrations, how to adjust the device and recalibration.
  6. Traceability: This is one unique aspect of calibration. All measurement results must be traceable to International System of Unit standards via a reference to a primary standard or a natural constant.
  7. Sampling: This can be considered its own element because of the specific statistical expertise involved. Gage repeatability and reproducibility (R&R) studies should be designed to accurately estimate a measuring device’s measurement error and ability to distinguish between different parts. Good gage R&R practices should be used, such as randomization and blind studies. When it comes to executing measurements of products, valid statistical sampling—ideally, risk-based—is also necessary.
  8. Nonconformance: If a nonconformance is identified with IM&TE, the measuring device should be identified as nonconforming and not used until it’s corrected. Consequences for, and disposition of, an affected product also must be determined.
  9. Records: These are the back end of quality-system documentation. They often consist of completed, controlled forms. Integrate metrological records into the quality system, and define their retention periods. Use these data to identify improvement opportunities.
  10. Improvement: This is listed as a quality management principle in ISO 9001, but the specific application of improvement to IM&TE is in ISO 10012. Basically, you can’t go wrong by applying the plan-do-check-act cycle to the metrology program. Keep track of nonconformances and problematic IM&TE to identify which areas to improve first. Use quality tools to select projects, such as Pareto charts. Then do a root cause analysis, and select and implement solutions using a structured problem-solving approach that’s supported by your organization.

A metrology program has a huge effect on an organization’s quality. Metrology is foundational to product integrity and inspection validity. From the end user’s perspective, the perception of an organization’s quality is only as good as the quality of the products it supplies. Accurate measurements prevent dissatisfaction, complaints and recalls.

Furthermore, metrology is a benefit to the business itself. A metrology program ensures there’s reliable data that may be used to reduce the amount of inspection and ultimately reduce cost over time. And new products can be brought to market faster with reliable validation data.

Regardless of where a product is in its life cycle, even best practices—such as design of experiments and statistical process control—are ineffective without accurate measurements. To highlight another quality management principle from ISO 9001, consider that "evidence-based decision making" obviously assumes the evidence is a product of accurate data. And that is what a good metrology program will provide.

Scott A. Laman
Senior manager, quality engineering and risk management
Teleflex Inc.
Reading, PA

References

  1. International Organization for Standardization (ISO), ISO 9001:2015 Quality management systems—Requirements.
  2. ISO, ISO 10012:2003 Measurement management systems—Requirements for measurement processes and measuring equipment.
  3. ISO and International Electrotechnical Commission, ISO/IEC 17025:2005—General requirements for the competence of testing and calibration laboratories.
  4. ISO, ISO 10012:2003 Measurement management systems—Requirements for measurement processes and measuring equipment.
  5. Ibid.

Surveillance audits required?

Q: If you are an ISO 9001:2008-certified organization, do you need yearly surveillance audits? My organization performs yearly internal audits and was audited in 2015 by our outside registrar. Our certification does not expire until 2017.

Barbara Emery-King
Newton Falls, OH

A: The surveillance frequency is at the discretion of the certification body, based on the maturity of the auditee’s management system, its performance, the context of the organization and risk. If the organization has quality-related customer complaints or chronically poor quality, the certification body should do more on-site auditing to determine whether there’s a quality system root cause and why problems are not being corrected over time.

In this situation, some on-site audits could be considered "for cause" or "special cause" audits. I would question the effectiveness of doing an annual internal audit if your certification body is auditing at a higher frequency and is finding systemic issues.

Internal auditing should be used to find and address issues before a customer or interested party finds them. There also may be an accreditation body requirement for your accredited certification body for conducting surveillance at a specified frequency.

R. Dan Reid
Director of standards and consulting
Omnex Engineering and Management
Ann Arbor, MI


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