Inadequate or ineffective CAPAs have remained the number one problem whether the CAPAs are to address deficiencies identified during audits or internal sources. It not only bleeds the companies financially due to recurring quality problems but also saps the morale of the people.
Why have the companies not been able to address this? To look at the “costs” lets pick two major sources of CAPAs. The audits and the market complaints (consumers or patients).
Audit is a serious and time consuming activity. Irrespective of the size or the history of the auditee, the day they get notified about an audit, they start making preparations. Mostly small or big teams start working on looking at the potential sources of deficiencies and start plugging them or making justifications. The auditors also have to make preparations – reviewing data, history, and interviewing stakeholders. And that’s not all, during the field work there is lot hard work and intense discussions about the outcome.
Complaints. Every complaint is a potential reputation and business risk. Depending upon the seriousness of the complaint, companies respond to the various stakeholders and the complainant. Its sometimes like a fire fighting exercise the moment complaint is received, the more serious the complaint the bigger the initial fire fighting.
In both cases, lot of energy, time and resources are spent upto thus stage. In both cases, top management and senior managers are actively involved till this stage. But what happens next? The moment the audit is over or the initial fire, in case of the complaint, is doused, the next actions are left to assistants. Investigation and Root Cause Analysis for the deficiencies identified are left to juniors in the team, as the seniors get busy with “more important” routine tasks. CAPA finalisation also becomes their responsibility. And sometimes when they approach the management for guidance or resources, do not get the expected response, they come out with poor quality investigation reports and so called root causes which result in equally poor quality CAPAs. This starts a vicious cycle.
Effective CAPA, by its definitions is expected not only to root out the deficiency identified but also strengthen related systems and theoretically any organisation, after 2-3 cycles of audits should have an effective and matured quality system in place and no repetitive complaints. In most cases, this is not the case.
But is it so difficult to come out of this cycle? Not really. All said and done, after the hectic activity before and during audit people show signs of fatigue. So the junior members of the same team which worked during the audit or the initial fire fighting for the complaint should not be made to work on the next steps. There should be a smaller but separate team of people with requisite resources and authority to carry out the investigations, come up with CAPA, and ensure their implementation and effectiveness check. Additional costs? Yes, but only initially. Over a period of time, the overall costs will come down and quality improve. Try it.