The benefits to having a Quality Management System (QMS) are generally well known and understood. Having a quality framework throughout the product lifecycle has been proven to help close compliance gaps and drive efficiencies within your QMS quality teams. It’s important to not only have a QMS, but to also make sure your QMS is meeting your specific requirements. The best way to evaluate your quality system is through a QMS audit.  

What is a QMS audit? 

A QMS audit evaluates an existing quality management program to determine its conformance to company policies, contract commitments, and regulatory requirements.  The objective of a QMS audit is to verify the compliance of the department or organization to the defined QMS and the regulatory requirements.   

Performing an internal QMS audit will provide the assurance and confidence that the defined requirements of the organization are being complied with as well as help prepare you for any customer audit or regulatory agency inspection. Another benefit of performing a QMS audit is that not only will it identity any flaws in your system and areas for improvement, but it will also highlight your company’s strengths. It will help provide your management team with the knowledge needed to ensure that your company is running to the absolute best of its ability. 

Performing a QMS Audit 

In order to begin the audit, it’s important to first clearly identify the regulations and product requirements with which you need to comply. This is done by reviewing your product lifecycle state, the regulatory environment within which you operate, and any unique product or process specifications that need to be met.  Based on these parameters, you will know what requirements must be met in order to remain compliant.  

After you have clearly defined the requirements, it’s time to determine how your quality management system aligns with the requirements. You will need to perform a gap analysis to compare each identified requirement against your current capabilities and processes. This is most often done by using an assessment checklist that can be customized and adapted to specific needs of your organization. For each identified requirement, you will want to identify how you are meeting the requirement and ensure there are clear records to document how it is being met.   

Many of the key factors to be considered include:  

• Ensure that each process is clearly defined and documented  
• Check that all SOPS and process documents are current and correctly reflect the process they describe 
• Verify that validation of any system has been completed and documented as required 
• Review training records to make certain all employees have been properly trained for the work they do 
• Make sure that any system used for making decisions has clean data – the conversion of data to useful information depends on the integrity of the data in the system 
• Look at any metrics you’re using to assure that they are based on valid data and properly reflect the information you are looking for 
• Confirm that you have reliable and trustworthy records that will withstand the scrutiny of an audit 

As you are looking at each area, you will likely identify some gaps to be corrected as well as areas that are working well. After you know where any issues are, you will then need to determine how to correct them.  

Remediation and Follow-Up 

After you complete the QMS audit, you will have a list of issues to be resolved. The first step in making a remediation plan is to prioritize the issues. Think about which items are most critical to bring you into compliance.  

For each issue, you will need to specifically identify what the gap is and what’s needed to close that gap. You will need to identify a specific person or department responsible for the action and may need to develop a team to make the correction. For some issues, it might be as simple as updating an SOP to properly reflect the current process. For others, it could be as complex as having to perform a complete computer system validation on a system that had not been documented properly.  

The best way to capture and keep track of all action items needed is to develop a project plan with a timeline to completion. This will help you make sure all actions are completed as needed. It’s also suggested that you set up a plan for periodic future QMS audits to ensure that you remain in compliance. 

Clarkston Can Help 

This may sound like a lot to address, but Clarkston is here to help. We have experienced quality and compliance consultants who can guide you through every step of this process and ensure that your QMS is in compliance and working to its strengths.