ALIGNING WITH AUDIT READINESS

The Auditor KNOCKS at the factory gate, Hello, we are from FDA.  And it leads to increasing BP, lots of stress, tension & sweating inside the premises.  What will happen?  There are gaps, many unattended open issues, and all sorts of nightmares start floating in front of our eyes.  

Why does this happen?

In my earlier BLOG, I discussed about RISK.  In fact our existence depends on our ability to cope up with RISK effectively.  Less are we vigilant to identify the risk around us, more will be the opportunities, the auditor(s) will have to screw us.  

We are the key to decide the outcome of an audit as, Good or bad.  Don’t we think so?  It is as simple as; during our studies, if we were well prepared for examinations, then we were confident of getting a good percentage and in case of any loop holes in the preparation, we were under stress.  Isn’t that so?   

Factors to consider for maintaining all time compliance:

1. Proactive approach & Planning

Proactive approach, quick planning & its execution is the key to success.  Sometimes, we miss the proactive approach and allow the issues to crop up, if planning is done, then its execution should be immediate as per the schedule and monitored by seniors.  We need to develop tools for monitoring. This will help us keeping up with the pace of the activities and in a state of all time audit preparedness.    

2. We should ONLY be data driven

Our decisions should be based on the review of relevant data.  In case the data for review is not adequate, collect more data to scientifically support our decision.  

When we say that ‘Data is not adequate.’  What does that mean?  As I always emphasize on the Risk driven approach, it will help us in identifying all the possible dimensions of studies & data required to scientifically justify the concern.  

Any matter supported by Risk assessment, followed by documents to mitigate the risk and a suitable CAPA, we will be able to effectively address the problem.  Also it will help in adding auditor’s confidence in us. 

An audit is DATA driven along with the risk.  Data integrity is a Branded deficiency in many audits now.  Auditors, during the review of documents or activities, try to get assured that there is no data integrity issue.  A gap in availability of data results in issuance/generation of a Critical Non-compliance. 

3. On line documentation 

We document the activities on line, but sometimes when we miss it may result in availability of inadequate information. Documentation done back dated, is not only a concern for the Regulatory inspectors, but also a concern for the Management, as it will not allow us to understand the root cause of any incident, as we won’t have a real time data.  Result will be a Weak CAPA.  

Recent guideline on Data integrity recommends that the data should follow ALCOA principles.

Accordingly, the DATA should be

Accordingly, the DATA should be
A	Attributable
L	Legible
C	Contemporaneous
O	Original (True copy)
A	Accurate

For example, if we don’t follow the principles of Data integrity, don’t address the problem at the time it happens and leave it for tomorrow, or the document for the sake of completion, with a planning that we will have to review it before the audit.  THEN, we have lawfully invited the problems for us.

4. Quality Management System (QMS)

Walk through the Non-compliance observations during any inspection, QMS is at the TOP, because QMS directly reflects our expertise in Technical & other matters. At Day one of the inspection, an auditor collects all the data of our Deviations, OOS, OOT, Failures, Change controls and CAPA.  A quick review of the list of these creates an image at his mind.  In fact that is one of the turning points during the audit.  If our QMS data can speak for itself, our Technical persons have interacted effectively with the auditor, then be assured that, half of the battle is won.  

A simple approach of On line addressing the QMS incidents, with defined time frame, using Trained & expert Technical team, with a proper risk assessment and scientifically derived CAPA will help to fortify this area. 

5. Trainings

Training is another area of serious concern not only for auditors but also for the Management.  Some might think that Training is a waste of time, but truly speaking it is an investment for our better future.

Less focus on trainings will increase more focus on problem solving.  So we need to decide, where we should focus.  It is like a principle of LEARNING & then EARNING.  

The more we will Learn through training, the less we will have problems to handle, and we will be able to invest our resources for improvements.  It implies increased rate of growth, w.r.t quality & quantity both.

Training should be planned by visualizing our SOPs & operations, considering smallest possible activity, which we might miss.  Equally important is the time to time evaluation & effectiveness checks of training.   Every organization should develop tools to ensure the effectiveness of training. Record of the same should be maintained. 

6. Keep control on Emotions

Being emotional, having healthy relations and emotions is good, but when it comes to our workplace, we should learn to keep our emotion apart. A workplace isn’t a place for emotions but a place for actions.

You shouldn’t just casually ignore something, “Yarr Chalta Hai, Aage se Dhyaan Rakh (it’s fine but take care from next time onwards)”, because someone’s close to you.  Also, since it was just a friendly advice, you never know how much that ‘friend’ is going to implement it in the future.

Once the audit is in progress and you’re caught in a loop, you think, “O YAAR, MARVA DIA (Auditor almost killed me for that one)”. 

So just keep it professional, not emotional.  Follow Profession, NOT Emotion. 

Purpose of starting writing this blog is to share my thought process with the industry. I am sure this blog will certainly add value to our thought process. I’ll see you guys next time, with some more value addition.