Risk-based Quality Management System (QMS) for Construction Materials Testing Laboratories
BY Jayanth Kumar Rayapeddi Kumar, Dave Savage, Paul Matera
Good business leaders understand that higher quality generally equates to lower overall risk to the company—lower risk for defective products, associated lawsuits, and the resulting loss of reputation and sales. Let’s look at building a risk-based quality management system (QMS) in your testing lab to meet or exceed a variety of accrediting agency standards, such as the American Association of State Highway and Transportation Officials (AASHTO), ASTM International (ASTM) and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC).
QMS is Required
Construction materials testing (CMT) labs that provide testing services on publicly funded projects are required to have an approved QMS to meet the quality requirements of AASHTO R18, ASTM D3666, ASTM C1077, ASTM D3740, ASTM C1093 or ASTM E329. This requirement is typically contract or specification driven and will depend on the scope of work for the project. While most CMT labs pursue these standards as a framework for developing their QMS, many go above and beyond.
Many labs follow a more robust outline to deploy their QMS to showcase their lab competence and uphold higher standards. Many quality experts consider the ISO/IEC 17025 standard “General Requirements for the Competence of Testing and Calibration Laboratories” one of the most reliable standards for developing a QMS.
Deploying a risk-based QMS that conforms with AASHTO, ASTM, and ISO/IEC quality standards is a rigorous task.
When a QMS is developed to meet regulatory requirements or exceed minimum expectations, lab managers often need help to define the scope and extent of policies, procedures, processes, etc. Their challenge is exacerbated by the industry’s continuing evolution and lessening room for error. QMS is always a work in progress.
Risks, and their associated tolerance, are critical components for any lab operation, but they’re hard to identify. Some are harder to quantify. When risks creep into a QMS, they weaken the system, making it unreliable and prone to manipulation. At the very least, a risk assessment should include risk probability, severity and existing mitigation techniques.
The current version of the ISO/IEC 17025 standard, released in 2017, applies risk-based thinking to developing a QMS. It doesn’t provide any prescriptive solutions to manage risks. Instead, the standard requires the lab to perform a risk assessment and develop a management plan based on the risk’s influence on performance.
The standard gives sufficient discretion to lab managers to assess and manage the risks as they see appropriate. We’ll examine two sections of the ISO/IEC 17025 standard from the risk assessment and management perspective as it applies to CMT labs to demonstrate the risk-based approach to developing a QMS framework. The risk severity and probability for any given section in the ISO/IEC 17025 document will likely differ for different labs; Therefore, consider how the risk assessment and management plan discussed in this article could meet your organization’s needs.
Section 4.1: Impartiality. Risks from perceived bias have always been around, but with the current ISO/IEC 17025 standard, they need to be addressed by assessing and suitably managing them. These risks can range from innocuous to detrimental to any lab’s operation. For example, a personal relationship between a lab staff member and a customer can cause any reasonable person to question the impartiality of the lab finding. If management considers an issue like this harmful to its business, it is in the lab’s interest to establish policy guardrails to curb such problems. To manage the risk described above, the lab can have a policy that says if the customer and a lab member have a personal relationship, that lab member shall work on the customer’s project under the direct supervision of another lab personnel.
Section 8.7: Corrective action. Nonconformities are inevitable in any lab testing operation. But not all nonconformities rise to the level of requiring a risk-based corrective action. Some are isolated incidents that require a one-time corrective action. If the issues start recurring and become severe, there may be a good case for planning to manage that risk. However, it’s challenging for labs to assess the reason(s) for nonconformities and implement timely and effective corrective action. Let’s look at an example. A lab technician repeatedly failing to follow correct sampling procedures certainly could rise to the level of risk assessment. Managing this risk may include, among other things, retraining the technician to perform their task per the relevant standard methods.
The lab should always consider the severity and probability of risks when planning the scope and extent of how to manage them. When planning risk management steps, a good formula is to use the PDCA rule: plan, do, check and act. To elaborate, plan what you will do when there is a risk, do what you planned, check if you accomplished what you wanted, and act on the gap between the plan and accomplishment. The other big part of resolving any issue is to keep all parties in the loop if needed. This will go a long way toward resolving problems and gaining stakeholder credibility.
A QMS is like a musical ensemble, if you will. In a musical ensemble, a group of well-rehearsed musicians plays a piece together in accord. It rarely happens that a change made somewhere or a lack of harmony among musical notes goes unnoticed in the final production. Like a musical ensemble, all it takes is one element of the QMS not to meet its quality objective, potentially reducing its overall effectiveness. Therefore, the lab staff should ensure that all aspects of the QMS are performing optimally. Deploying a risk-based QMS that conforms with AASHTO, ASTM, and ISO/IEC quality standards is a rigorous task. It is common to feel that the QMS is a burdensome requirement for companies to comply with. However, not having a functioning, structured, risk-based QMS could lead to failure for any lab. A reputation for inconsistent or unreliable results does the very opposite of driving sales, especially in the built environment.
Jayanth Kumar Rayapeddi Kumar, PE, ENV SP, currently serves as the quality control engineer for Jas. W. Glover Ltd. in Hawaii, and on the ASTM D04 committee on Road and Paving Materials and the ASTM E36 committee on Accreditation and Certification. Reach him at firstname.lastname@example.org.
Dave Savage is the director of accreditation for CMEC Inc. and serves on ASTM Executive Committees E36, Accreditation and Certification, and D04, Road and Paving Materials. Reach him at email@example.com.
Paul Matera currently leads the Inspection Body program for the ANSI National Accreditation Board (ANAB). Before joining the ANAB staff as a senior accreditation manager, he provided assessment services to different accreditation bodies and industry groups. Reach him at firstname.lastname@example.org.