OPC/U5 Topic 6 Strategies for corrective action
Step 1: Understand System Requirements (Plan)
Seeking understanding before action is the first step in creating an effective corrective action system. While quality standards spell out the various requirements, it may take some due diligence to understand exactly what needs to be done.
Documentation needs and corrective action procedural requirements must be accurately assessed in order to minimize implementation missteps.
Step 2: Plan the Process (Plan)
Planning is the design phase where decisions are made regarding the framework and mechanics of a corrective action system, including how to integrate the system into current operations.
Planning should also address personnel duties for the corrective action process. More specifically, procedures and conduits must be planned for completion of the following key tasks:
- Evaluating and assessing non-conformance triggers (customer complaints, audit findings, process parameters, etc.)
- Identifying legitimate non-conformances and related issues
- Capturing and entering issues into the corrective action process
- Investigating and getting to the root cause of an issue
- Determining and implementing solutions
- Reviewing, checking, and verifying the effectiveness of a problem resolution
- Using risk management protocols to ensure major non-conformances are top priority
- Establishing personnel responsibilities at various stages of the corrective action process
Step 3: Develop and Document (Do)
In this development stage, a cohesive corrective action system is created according to a well-developed plan. Teams are formed and given the authority and responsibility to fully develop the program.
Team duties include making sure the corrective action system is structured properly and is functional and compatible with existing quality management elements that provide nonconformance alerts.
Activities at this stage also include formal documentation of policies, procedures, and responsibilities for system caretakers and users.
Step 4: Conduct Training (Do)
Implementing any new system can significantly upset the norm, creating anxiety for those affected by the change. For something as big as a corrective action system that reaches across business operations, changes in management demand adequate training.
Training should involve interactive learning events that tie directly to job duties and should include hands-on practice, with on-the-job learning sessions, tabletop simulations, case studies, or a mix of all three.
If the plan is to use an electronic system to capture nonconformances, for example, then training must cover how the system works, explain access details, and describe pertinent data fields. Plus, personnel must be able to practice data entry using several different corrective action scenarios.
Effective training lays out the process from start to finish so that personnel gains the understanding, skills, and knowledge needed to carry out corrective action tasks accurately and with confidence.
Step 5: Implement (Do)
After training, implementation of the corrective action system should take place as soon as possible to lessen the gap between training and actual use of new skills and knowledge.
In this step, corrective action procedures go live, and system mechanisms are fully operational. Instructions and methods are in place for designated personnel to thoroughly manage corrective actions.
Step 6: Test the System (Check)
After several corrective actions travel full circle, the next feat is to check that the system performed as intended. The goal is to verify functionality and use. The check can happen by auditing a sampling of corrective actions from system input to investigation, resolution, and closure.
Audit findings may contribute to future corrective actions and changes. Where changes are made, it is important to notify and train affected personnel.
Step 7: Adjust and Improve (Act)
In a perfect world, everything goes according to plan. In the real world, glitches are likely. For this step, adjustments are made to improve the corrective action process.
Actions are taken to fine-tune the system to the point that nonconformances are reliably detected, evaluated, and resolved. The goal is to make corrective action management a consistent and effective process through continuous improvement.
A proper corrective action system detects and resolves nonconformances. By including the Plan-Do-Check-Act cycle in implementation efforts, launching a successful corrective action system is well within reach.