You are ready to grow your approach to quality that go beyond the basic controls you now have in place to deliver insight across the product lifecycle. Beyond core functions such as document control, corrective actions and employee training, there are some key capabilities you should consider.
Nonconformance handling is a great next step. When you are able to manage all of your nonconformances in a centralized system, you have a better way to track issues and perform root cause analyses. You can track customer feedback, so small problems don’t become larger issues that have a serious impact on your organization.
Your organization has multiple enterprise systems that have information that would be useful for quality. While integrating multiple system can seem like a large task, you can start with one system and add additional integrations in the future. One of the first systems where you can drive synergy with your QMS is your ERP. In fact, you can leverage nonconformances and corrective actions to drive change in your ERP. What if a nonconformance reported in the QMS could automatically put materials on hold in the ERP? You could limit your exposure to quality issues leading to large scrap and rework costs. And this is just one example of an integrated process that can make you and your team more efficient and significantly reduce costs.
Nonconformances and corrective actions can occur well after you’ve designed your products and you are tracking quality during production. We know that the earlier you catch a problem in the product lifecycle, the less expensive it is to correct. So, designing quality in at the beginning is critical, which impacts the other end of the product lifecycle when you bring new products to market.
And, even with the best processes and quality programs, customers can still run into issues. Therefore, being able to manage customer feedback, and regulated customer complaints for life sciences organizations, can help identify and react to issues more rapidly, allowing you to better manage the risk associated with your products. And to track all customer feedback, another key integration point is with your CRM.
By capturing customer feedback, by integrating with other key enterprise systems, you can take audit readiness to the next level as well. “Always audit ready” is an important, if overstated, catchphrase in the quality space. For organizations that host multiple customer audits, regular internal audits, and at least one regulatory audit per year, being “always audit ready” is not just a matter of frequency, but also optimizes your resources.
By taking these steps, the QMS will also prepare you to provide secure policy access for your suppliers in the future. Now is the time to start thinking about how you get suppliers integrated into your quality processes. You should begin to understand how they measure quality and define acceptable quality levels. And as much as you get audited, consider auditing your key suppliers. It’s time to hold your suppliers accountable.
being able to manage customer feedback, and regulated customer complaints for life sciences organizations, can help identify and react to issues more rapidly