As much as we attempt to avoid nonconformities (NCs), they are bound to occur regardless of the competencies, written instructions, and preventative risk mitigation in place within an organization.
Nonconformities can come from internal and external audits, complaints, feedback, or all varieties of nonconforming work. While the task of completing a corrective action may seem daunting, the following flowchart highlights the fundamental elements of the corrective action process with respect to the requirements of ISO/IEC 17025 Section 8.7.
8.7 Requirements
8.7.1 a
- The NC shall be documented and acknowledged as part of the quality system.
- Once identified, the NC shall be controlled and reviewed to understand its scope and impact.
- Actions shall be taken to resolve the immediate impacts of the NC.
8.7.1 b
- Perform an evaluation of the NC to determine potential causes and contributors, as well as, if any additional NCs have occurred as a result.
- Develop a plan, if needed, to eliminate the causes.
8.7.1 c
- If a corrective action is deemed appropriate to address the NC, execute the plan.
- Note: Corrective actions must be proportional to the nature and severity of the NC (see 8.7.2)
8.7.1 d
- After implementing the corrective action, an effectiveness review shall be performed to confirm that the NC has not recurred.
- Note: It may be advantageous to schedule this review 1 to 2 months after the corrective action has been implemented, in order to have enough data to reliably verify that the NC has been resolved.
8.7.1 e
- As appropriate, revisit your organization’s risks and opportunities list (see 8.5) as you develop your corrective action plan for potential modifications.
8.7.1 f
- Per 8.7.1.c, confirm plan has been carried and the management system has been updated, if needed.
- Note: In the event that your management system documentation has changed, or you have introduced new documentation, it can be helpful to make sure that relevant staff are made aware of the changes. This may include, staff training, email notification, or meeting minutes.
Keep in mind, per ISO/IEC 17025 8.7.3., records should be kept for the actions taken in 8.7.1.
EXAMPLE: Corrective Action Process
The following example will utilize the corrective action process laid out in ISO/IEC 17025.
Scenario
Generic Testing Inc. has gone through ISO/IEC 17025 external audit with their accreditation body. At the closing meeting, the quality manager, Mike Wazowski, is presented with the lab’s nonconformities and is asked to provide a response within 30 days. After the assessment occurs, Wazowski begins the process of resolving the nonconformities. He schedules a meeting with his quality team and begins addressing the first nonconformity.
Nonconformity
Requirement: ISO/IEC 17025 6.4.4. The laboratory shall verify that equipment conforms to specified requirements before being placed or returned into service, and 6.4.13.c evidence of verification that equipment conforms with specified requirements.
Objective evidence: During the assessment, it was found that the tensile tester (ID: 27984) did not have evidence of being verified before it was returned to service.
8.7.1 a: Identification and control of nonconformity
Wazowski begins the process by documenting the NC on his corrective action form, CAR-01. Within CAR-01, he states the nature of the NC and the impact it has on the laboratory activities. During the review with his team, he determines that the lack of verification has impacted his test results. As a result, Wazowski recalls the work impacted and orders retests. At this point, the extent of the NC has been identified, both the immediate impacts and the impacts on previous test results.
8.7.1 b: Cause analysis and corrective action plan
Next, Wazowski begins the cause analysis process. Within his management system, they utilize a variety of cause analysis methods, such as a fishbone, the 5-whys, and affinity diagrams to dissect and identify all contributors to a NC. In this case, Wazowski has opted to utilize the 5-whys:
1) Why wasn’t the equipment verified before returning to service?
- The technician assumed the equipment would be fine.
2) Why did the technician assume the equipment would be fine?
- The technician assumed that if the equipment came back from calibration, the equipment would be ready to return to service.
3) Why was the technician under the impression that calibrated equipment equated to verified equipment?
- The technician was never informed of the process for receiving and returning equipment to service.
4) Why was the technician never trained on the correct process?
- During the time the technician was in training, there was also a change in quality managers. The previous quality manager was scheduled to perform the training, as such it was missed.
5) Why wasn’t the missing equipment verification training caught before authorizing the technician?
- The equipment verification process wasn’t a part of training checklist.
Root cause: The technician responsible was not formally trained on the equipment verification process prior to authorization due to the training.
Note: The 5-Whys don’t necessarily need to end at reason 5. You can continue to ask “why” (e.g. in the above example, an additional why could be “Why wasn’t equipment verification part of the training checklist?”), or you can stop the questioning earlier (e.g. maybe you want to stop at 3 and conclude training is the issue instead of digging deeper into the specifics). At the end of the day, it is your responsibility to adequately address the NC, keeping in mind that it should be proportional to the severity of the NC.
Upon determining the root cause for the NC, Wazowski and his team map out a corrective action plan.
- Train the technician in question on the correct equipment verification process.
- Update the training checklist to include equipment verification.
- Review and update training and equipment procedures to describe the equipment verification process and associated records.
- Confirm that all other technicians have been properly trained.
- Confirm that all the equipment returned to service in the past 6 months have their corresponding verification record.
8.7.1 c: Execution of corrective action plan
Wazowski delegates the corrective action plan to his team. The items are completed at various times, and he updates CAR-01 accordingly. After the plan is completed, Wazowski assigns the effectiveness review to his general manager, James P. Sullivan.
8.7.1 d: Effectiveness review
Two months after the corrective actions have been implemented, Sullivan is notified that the effectiveness reviews are due. To confirm the resolution of the NC, he performs the following:
- Sullivan gets a list of equipment that has been returned to service in the past few months and confirms that the equipment has been verified.
- A new technician has been hired and training will start in a couple of weeks. Sullivan follows up on the technician’s progress. He confirms that the technician received the training on equipment verification and it has been noted on the checklist.
8.7.1 e: Risk and opportunities
Wazowski reviews the NC and identifies the following to add to his list of risk and opportunities:
Risk: A negative impact on the testing results provided to customers due to an oversight in equipment verification
Opportunity: A chance to review the current processes in place and confirm that all aspects of ISO/IEC 17025 are addressed
8.7.1 f: Confirm implementation within the management system
As a final step, Wazowski confirms that all aspects of the plan have been fulfilled and any changes to the management system have been finalized.
8.7.3: Records
After completing the correction action and confirming the effectiveness, the finalized corrective action form is logged within Generic Testing’s quality database. Wazowski completes this process for the remaining nonconformities received during his external audit.
For more information on the corrective action process, contact A2LA at 301.644.3248 or email us at info@A2LA.org. To request an estimate, visit our website here: https://a2la.org/estimate-request/.