Quality System Improvement and Remediation Consulting

Per FDA 21 CFR 820 and ISO 13485, medical device quality systems have a mandate to continually improve.

On a typical basis, the ordinary CAPA and improvement processes drive this activity. But what if a gap in the CAPA and improvement processes is identified? What if an audit finding reveals a need to remediate a quality subsystem, which if left unchecked, has the potential to harm patients?  These situations can arise with even the most conscientious actors, who unintentionally have an organizational blind spot.

Compliance Team is familiar with these situations, which often result from a training/awareness gap.  Our first task in these situations is to help you find the root cause of the problem and to document it in a CAPA investigation.  Next, we address the problem using a past/present/future model – We evaluate the past events to assess their potential or resulting harm, we change current practices to reduce the likelihood of harm (containment action), and we make the necessary long-term changes needed to prevent the gap from arising in the future (corrective/preventive action).  Our experts are trained to evaluate by using careful study.  If a process is yielding favorable results, we ensure that the favorable parts remain intact.

As you might expect a remediation requires hard work and discipline, and your company will own the solution. Compliance Team therefore ensures that your company is intimately involved in the remediation process, but we don’t expect you to manage on your own.  As your company takes its first uneasy steps into the unknown, Compliance Team will provide expertise and wisdom earned through experience to provide training and to address your concerns every step of the way.  Our involvement ensures that the remediation becomes a value add to your quality system and helps companies to become an operating model for profitability, sustainability, and efficiency.

If I need to remediate my QMS, how can I leverage it to improve overall organizational health?