It is not uncommon for quality leaders to be informed on a Friday about an inspection at one of your locations the following Monday.
What would your reaction be if that were the case? Would you panic or is it no big deal because you’re well-prepared for it?
The true hallmark of a good quality leader is preparedness. With the right automation and digital tools in place, it is extremely important for a quality leader to drive a data-centric, collaborative approach to any quality process.
Inspection readiness is no different. As a quality leader, it is not only about regulatory
compliance but also about driving an organization-wide mindset to pursue quality excellence. A QHSE that can drive continuous improvement of quality and safety best practices is always in need.
ComplianceQuest Inspection solution makes it extremely easy for quality leaders to do the following:
- Set criteria for inspection
- Integrate with ERP systems
- Conduct Inspections
- Integrate to non-conformance and CAPA solutions
- Access key data using Einstein Analytics
The 5 Phases of Inspection Readiness
There are five inter-related phases for any inspection process:
- Lessons Learned
These are the phases of a closed-loop process where information and actions from one phase impacts the next. Define, document, and implement an inspection readiness program that proves that your quality system operates in a state of control and that you are meeting the needs of your stakeholders, including internal and external customers, notified bodies, and regulatory agencies.
Plan and Prepare
Inspection Readiness should be a well thought out process involving every employee, giving them time to attune themselves to the needs of being prepared. Giving them sufficient time and training is critical to getting their buy-in and meaningful participation.
Though you may wish to be in a state of perpetual readiness for any audit situation, you cannot focus on everything with the same level of rigor. Therefore, it becomes important to plan and prioritize areas of focus, and a good guideline is the 80:20 rule. Define the criteria that determine which areas are critical and contribute to the highest level of safety, quality compliance, and risk mitigation.
Schedule multiple sessions for the team with the processes and procedures and the key is practice, practice, practice. For onsite inspections, a walkthrough is a normal part of the activity. Make sure everything is clean and whatever is required as part of safety, health and environment should be followed to the T.
If you put something in your procedure and don’t follow it, it becomes an observation because now it has become a law, and for the notified body, it has become part of your system. Records should be prepared as expected and be readily accessible.
Some of the key steps for IR preparedness would be:
- Review your quality data sources and know what they are, where they are, and how you use them.
- Assess what needs to be reported and which need not be. However, if the inspector decides that they need to be reported, then that’s an automatic warning letter, so go over them with great rigor.
- Go through your safety and corrective actions to eliminate internal product or process non-conformance, high-risk CAPA, complaint handling, and the like. Having an enterprise-wide quality management system makes access to information easier.
- Designate a meeting room or a strategy room, sometimes also called the war room.
- Have a communication strategy in place, not just for the quality team or the subject matter experts but even the receptionist.
- Sharing of information with your colleagues is important, but you also need to limit some of the information and decide who needs to get it.
- Prepare your notification list with work and alternative numbers of backup reps and the core team.
- Set up an admin and core team members may consist of runners, scribes, facilitators, subject matter experts, or strategists.
- You might also want to include contract manufacturers, any offsite storage, or representatives that have the information you will need to access if it is not available onsite.
When you are working with different quality subsystems, identify an owner, and ensure cross-functional representation. Simulations are an essential part of the readiness program, done as a dedicated activity, or as part of your internal audit program. This is an opportunity for the owners and the users of the quality systems to not only know the processes, procedures, and work instructions but also understand the intent. This enhances your ability to work in a state of control and deliver what is required.
By understanding the intent, employees can take better decisions when an unexpected event occurs. They will understand the impact of the decisions on the processes and products, thereby reducing non-conformances and complaints due to the distribution of non-compliant products.
Clearly label the rooms, keep the required documents filed neatly and provide them with unique IDs for easy identification especially if there are multiple inspections/audits happening at the same time.
Have a post-inspection, close-out meeting to review what worked and what did not. Update and modify your processes and incorporate it as part of your quality initiative wherever necessary.
Establish processes and procedures based on the observations and use that as an internal audit tool for inspection readiness.
Management support is essential for businesses to become inspection ready. Equally important, an enterprise-wide quality, safety, health and environment management solution such as the one from ComplianceQuest can help create a culture of quality. This automatically aligns employees to the business and quality goals and keeps them prepared and ready for inspection at any time. It provides easy access to documents and CAPA, complaints, and other similar information that an inspector may ask for. It also alerts employees to any potential SHE risk situations.
As a quality leader, it is important to manage your inspections with ease using automation. It frees up time for strategic, higher-level tasks, while ensuring you’re running a robust inspection process that is data-driven and collaborative.
ComplianceQuest’s Inspection solution is part of our cloud-based QHSE solution, built from the ground up for the cloud. We believe that it is one of the best solutions in the industry for driving your QHSE process. Request a demo here: https://www.compliancequest.com/inspection-management-software/