Quality managers are well aware of the fact that QMS programs generate value for the organizations in which they are implemented; but there is an enormous difference between simply having quality programs in place and actually building a culture of quality. The latter takes considerable time and effort, but it yields very real dividends in terms of cost savings, customer loyalty, employee satisfaction, and more. 

We all know that quality is important, but quality initiatives sometimes carry less weight for others in your organization, especially if the resulting benefits are not visible to them on a regular basis. Effective reports help to communicate and establish the value of quality management activities. Just as importantly, reporting supports accountability by providing a visibility to the things that might not be working so well. That, in turn, can provide the basis for course corrections that ultimately help the organization to achieve its business objectives. 

We have all encountered people at one time or another who regard quality management as being far too bureaucratic, – dominated by unnecessary processes and excessive documentation requirements. In many organizations, unfortunately, this attitude is the norm. That usually happens when top leaders within the company are not fully committed to quality management programs.  

Everybody loves the idea of quality; but when it comes to quality programs, some people are not quite so enthusiastic. That’s a tragedy, given the fact that consistent and pervasive quality programs invariably produce positive results, yielding higher profits and increased customer satisfaction. When quality programs are poorly understood throughout an organization, though, they may be regarded as too restrictive and excessively focused on rule-following, compliance, and seemingly meaningless processes. 

A well-defined corrective and preventive action (CAPA) process is intended to identify problems, understand root causes, resolve issues, and take corrective action to prevent the recurrence of those problems. While the results are well worth the effort, designing and implementing a good CAPA process comes with some challenges. Here are some of the most common problems we see when companies are struggling with their CAPA processes. 

 Comparing software packages is hard.