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.
One of the most often cited finding in audits (FDA and others) is related to documentation: it can be related to the SOPs or the quality records – with top focus on data integrity these days. While some of the data integrity issues particularly involving electronic data require expert help, companies can easily get rid of most of other issues related to SOPs and quality records.
For SOPs, all you need to do is follow the basics, do what you write and write what you do. Check that it is so, and revise if required.
For quality records, design the recording formats carefully and ensure that reviews happen with due diligence. An important reason for data related issues is lack of the review.
And yes, every documentation problem is not a data integrity issue.
Lets get it right.
Every company has a training program, and some form of training effectiveness assessment. Still, If a thorough root cause analysis is performed for the audit findings, quality incidents or other issues, training will emerge as an important reason
I reviewed training in a large number of companies during the last 15 years as auditor and earlier. Barring few exceptions, the training(s) are performed more as a “tick in the box activity”.
A large number of SOPs are “Read & Understood” on a single day! Some of them running into 50 or even more pages! Induction training or the periodic refresher training. Not just the system related, even the site specific SOPs.
And then the questionnaires for assessment of the effectiveness of the training. A large number of the questions so simple and generic that any person with basic qualification & some experience for the role could answer without even opening the SOP. Assess what ?
We will continue to have recurring quality problems, till we continue with this “tick in the box” approach. We need to change it, make it more topic specific. And re-assess the assessment methodology.
Start today. Start Slow. But remain steady. The results will surprise you.
Used to rollover benches in the change rooms, I was surprised when I entered the change room of a factory in Japan manufacturing sterile products. No rollover benches. Knowing that I was in Japan, I steadied and prevented myself from making any comment or non-verbal gesture. That paid, what they were doing was more effective than a rollover bench. It is in their culture. Not to take street shoes inside any place. In fact there are rituals attached. No ‘evidence’ that their change rooms were not meeting the GMP requirements. In fact better as no monitoring or supervision was required.
Or their unique individual stamp “Hanko”. Whereas companies worldwide are struggling to train their employees on Data Integrity, Hanko ensures “Attribuable” –the first A of ALCOA. Culture again. And it’s not for nothing that Japanese Quality concepts are taught across the world. And for good.
The point is that each country, each society each region has a culture of its own. Why not link some of the GMP practices to the local cultural values? Social value system? Or traditions?
It will reduce the efforts required to implement GMP and achieve compliance a bit easy.