From December 26th on, you can’t help but see articles on the best and worst of 2010. We had Toyota, BP and eggs topping the news, and it didn’t shed much of a positive light on quality management. So as the new year kicks in, perhaps it’s time to examine your own products and processes in order to ensure compliance with organizational and industry regulations.
Internal audits can also be done to ensure compliance with specific regulatory standards and help prepare companies for third-party compliance audits. Internal audits, whether required or not, are highly recommended for all manufacturers to ensure compliance with industry guidelines. Be prepared for a great deal of advance planning though in order to have an effective audit. It can be time consuming and difficult to track (using Excel) without an automated software solution with solid reporting functions. Your efforts will pay for themselves in the long run because you will have factual, unfiltered data of your quality systems – a true objective assessment of your company’s products and processes.
What makes an effective audit? First of all, they should be completed at sufficient intervals of time within an organization. If you use paper-based or partial systems, you may have an even harder time updating and maintaining your records. Plus, it may be harder with these systems to view trends over time.
The FDA uses QSIT to look at your data. QSIT stands for Quality System Inspection Technique. In short, QSIT looks at whether the quality management system has been implemented effectively. The FDA realizes that quality problems happen, but what they’re looking for is what did you do about it and how are you going to keep it from happening again. QSIT focuses on seven major subsystems of a quality management system – Management, Design Control, Corrective & Preventive Actions, Material Controls, Records/Documents and Change Controls, Equipment and Facility Controls, and Production and Process Controls. If you’re using a paper-based or hybrid system, showing the connectivity of these systems may be difficult. Here are some other challenges you may face with an audit:
- Global planning and visibility across the entire organization and all product lines provide insight into consistency, quality control, and compliance. Paper-based or partially automated systems can hinder an organization’s ability to provide consistent data from the entire organization. Without connecting to other quality processes, like in non-automated systems, audit data will not link to CAPA or other system controls. This isolation, or islands of information, will prevent effective monitoring of the entire organization.
- Combined with the limited resources in internal auditors, or having to use costly third-party auditors and scheduling can consume the entire audit process. Once initial schedules have been agreed upon, conflicts and the subsequent need for follow-ups increase the difficulty. An automated system, again, can alleviate some of this trouble.
- Inconsistent checklists can contribute to varied audit reports. Incompatible data reports which focus on different observations and findings make it difficult to trend production processes and determine where the real issues lie. The lack of fully-automated systems forces auditors to complete their reports individually and manually, adding to the time it takes to complete an audit.
- Manually prepared audit reports have an increased risk for being late, or not being turned in at all. Audits completed by multiple people may not be properly merged together into one cohesive report. These obstacles increase the chance that high risk areas will be unidentified, which could lead to costly problems or compliance issues.
All of these issues emphasize the need for companies to manage their risks and meet standards and requirements in an effective and substantial way. In order to stay in business, they must take proactive steps to protect themselves. Implementing an effective, streamlined auditing and assessment process can assist companies in reducing costs, improving quality, and meeting all regulatory requirements.