A Preventative Action Request (PAR) is a way to recognize and document a potential cause or risk of a problem before it happens. It starts by proactively observing or identifying the cause and evaluating the risks, assigning it to a person or a team that will assess the situation and will create a mitigation plan or implement a solution to attempt to minimize the likelihood of the occurrence of the problem. It is very beneficial to understand the environment or the process where the risk is identified to appropriately assess the risk and define the next course of action.
It is important to have a tool that makes this process efficient and user-friendly and that allows the employees of the organization to act quickly, implement solutions and track statuses of progress. Here is a predefined set of steps that should be followed after someone observes a risk or a potential cause of a problem.
Report and document the potential cause or risk
To initiate the process, the Creator should describe the potential risk and provide concise information that will aid the Quality Systems Manager (QSM) to evaluate the risk and the next course of action.
Assign the case to a person or team who will assess the need for an action
At this point, the QSM will review the details, assign a PAR number, priority and criticality level, and assign it to an Investigator. The latter should be someone with the correct knowledge about the process or the environment where the risk was observed and should have the right level of authority to make decisions and changes. Some observations may not require an action, and in this case, the QSM should enter the existing risk mitigation and provide closing details to the Creator.
Investigate and implement a solution
Once the case has been assigned to the Investigator, this person should review the details, including the priority and the criticality, and act accordingly. Urgent priority or high criticality items must be given a high sense of urgency. Depending on the process, the Investigator may decide to launch a Failure Mode and Effect Analysis (FMEA), which is a tool that helps teams identify all possible failures within a process or design. Once the investigation is complete, a risk mitigation plan or solution should be implemented. If any standard operating procedures or guidelines are affected by the changes, these documents must get updated. As a result, training for the employees should be provided. The QSM may decide to approve the risk mitigation at this stage to ensure it appropriately addresses the concern.
Provide feedback to the Creator
Ideally, to bring closure to the request and show appreciation to the Creator for submitting the PAR, the QSM should provide feedback to the Creator with a detailed description of the risk mitigation.
WHO SHOULD USE THIS PROCESS
This risk-based thinking tool can be used by any type and size company, but it is primarily used by in-house and contract manufacturers. This process is usually owned by the Quality Department, and when promoted and highly supported by the leadership or executive team, it empowers other departments and teams to take ownership and participate in the process.
WHY USE THIS PROCESS
As companies allow and encourage employees to take action when observing or identifying the risk of a problem before it occurs, the safety and quality of the products, processes or services are often significantly improved. By having a robust process in place, following a predefined set of steps and having the ability to monitor progress, this risk-based thinking tool is a key component in achieving a solid quality management system. Every department in the organization, including but not limited to production, supply chain, warehouse or safety can take advantage of this tool to continuously improve and prevent problems. Ideally, the organization should find ways to motivate employees to submit PARs.
Preventative Actions complement Corrective Actions and some companies use the CAPA (Corrective Action and Preventative Action) system which addresses both of these processes. Refer to Regrello’s post on Corrective Action Requests (CAR) for best practices.
Creating a positive culture that focuses on continuous improvement and teaches employees to be proactive and involved in the overall quality of the company’s products, processes or services, very often results in greater customer satisfaction. In addition, by implementing a process designed to prevent problems from occurring and minimizing negative effects, companies can save large amounts of money on what otherwise could have resulted in customer complaints, defects, returns, or most undesirable, a potential safety incident.