Excuses for Not Improving Quality

[Jen Kirley]

If they are saying they need more staffing in order to do a quality job, what convinces you they aren't right?

Are there process bottlenecks that cause delays and frustrations?

Do they have everything they need, when they need it, including adequate instructions?

Have they been asked to do more with less - has the organization been through a labor cut without making process improvements to enable work to go more smoothly?

Do they feel like they have the ability and permission to get rid of nonsense that slows them down?

While some people will continue with the nonsense so they can be proven right that they are overworked, I think that most of us would prefer the constraints to good performance go away. But if there was a headcount slash you may be dealing with survivor syndrome. Has there been a downsizing recently?

 

[kgott]

One of the biggest "wins" my company achieved as we implemented ISO 9001 was getting up and running a functional CAPA process. In fact, it was a "meta-win", because this process makes improvement continuous rather than discrete. Each individual change is small, but permanent.

To this day, 5 years later, this CAPA process keeps generating a constant flow of small wins. Over 500 per year. These small wins polish every single process beyond anything imaginable when we started. Over time these add up to huge improvements in quality and every performance measure.

Pancho; many of us on this forum are aware that you have a wiki based document management system and gains that you have achieved by using a Wiki. In view of the wins you have achieved with your CAPA process, would you consider elaborating on how and why your CAPA process is so successful for the benefit of those of us who have much to learn from your experience?

thanks

 

[Pancho]

Pancho; many of us on this forum are aware that you have a wiki based document management system and gains that you have achieved by using a Wiki. In view of the wins you have achieved with your CAPA process, would you consider elaborating on how and why your CAPA process is so successful for the benefit of those of us who have much to learn from your experience?

thanks

Empowering everyone in the organization to make changes to the QMS is, I think, the reason why our CAPA process is successful. The wiki enables such empowerment by providing accountability and availability at points of use. "Use" includes consultation, of course, but also recording change, and even initiating it.

Despite the above, required process changes are often not obvious when spotting non-conformities, so the wiki alone is insufficient. NCs are valuable, as they flag requirement for change, but they don't tell what that required change is. The CAPA process provides a way to find out. It complements the wiki by providing a place for discussion, brainstorming, analysis, finding and recording root causes, proposing actions, and ultimately, recording related actions actually taken. Those actions may, of course, affect several documents in the system.

Sometimes users do know what change is required, but they may be unsure or apprehensive about their knowledge. For them CAPA provides reassurance and validation before editing process docs.

Another benefit is in the CAPA process's higher-level view. Anyone that has some experience with wikis knows that document improvement is a bit messy. Often, contributions are unclear or wordy. Sometimes desired improvements are recorded in the "wrong" document. Occasionally, a contribution is simply undesirable. Still, most contributions contain nuggets of valuable knowledge. Process owners and other users will correct many of these contribution problems on the fly, but sometimes a "refactoring" of documentation is needed. Such refactoring may involve several people working together and this is frequently done within the CAPA process.

The key is the empowerment bit. Such empowerment keeps processes and documents alive and constantly improving together.