Fact is, we all are Risk
driven hence, it is always worthwhile to practice a ‘Risk based approach’ at
work. Risk based approach prompts us to
act proactively. It is not a new aspect,
use of risk as a tool goes back to 1960s, when it was first used in the
Aerospace industry.
Now the point is, “what is
a Reactive compliance?” An incident takes place, we investigate, find the risks
associated with it, concludes a root cause and plan to prevent the repetitions
in future. It is true even at home or at
work place, we usually react once the incident happens. Or in other words, we wait for the incidents
to happen, to react and then comply, this is what is a ‘Reactive compliance’.
RISK & REACTIVE COMPLIANCE
It is evident that we can work
in compliance mode, only when we proactively address the risks or gaps associated
with a process or a system. To
understand the risks, we need to review our processes & systems as a part
of detailed review procedure, this is the
first step towards proactive compliance. Dilemma is that Self-inspection/Internal
audit procedures restricts the scope to the level of ensuring compliance with
the existing systems. It is always recommended to have a
procedure as a part of Quality Assurance system, so we are able to assess the
risks at defined intervals, which might still be left unnoticed.
Risk & reactive
compliance are two sides of a coin. Risk
is integral; we can always put our best to maintain it to its minimum. A
proactive approach to understand the potential risks in the process &
systems, may help us to plan Preventive actions in advance, i.e. a Proactive
compliance mode.
DISADVANTAGE OF REACTIVE COMPLIANCE
1. Live with the Risk
Take a simple example
of balance used for dispensing of raw materials in a warehouse. In its calibration is not reviewed critically,
it may lead to the Risk of adding incorrect quantity of raw materials to the batch,
resulting in quality concerns.
There may be many such examples, failure to have a proactive
identification of the risk or gap in the system or process will have far
reaching consequences, which will impact the quality of the end result.
Fact is that a reactive approach makes us to sit with the
risks and we become used to wait for the undesirable events to take place. It not only delays the timely actions but
also makes the situations complicated.
A typical example to this can be a checklist in the
warehouse, to facilitate the inspection of incoming materials. If it doesn’t state the verification of
weight of the Active raw material bags (25kg each), received in bulk, as
well as Identification test is also not performed on all 100% bags. It always leads to a scope for incorrect
dispensing not only with respect to weight but also mixing of any other
material in the batch, as identification test has been conducted on a few bags
only.
Missing a proactive
approach will take us to an undesired situation leading to a critical quality
problem, and a long list of QMS incidents.
This will follow an investigation, diverting resources for uninvited
problems to find out the root cause and a reactive compliance.
3. As incidents result in losses, we lose
productivity, time and credibility.
A QMS incident and
its remediation, requires extra resources, time and not only results in loss of
qualitative & quantitative attributes but also affects the credibility of
the team to deliver right quality product.
Compliance has certainly
been made, but at a higher cost, with
negative ‘Returns on Investment’ (ROI).
Consequently, a reactive approach is not a plan but a mechanics.
Finally, it all bounces during an external
review. We listen about the companies
with ZERO – 483 audits. It is not a
miracle, it is possible, we need to discourage the practice of Reactive
compliance and encourage a proactive mode.
A monthly review of ROI on the cost of product for the failures to
identify risks will certainly help in streamlining the process.
FOLLOW PROACTIVE COMPLIANCE
‘Proactive Compliance’ is the process of
investigating inconsistencies in a system or process, to understand the risks
& identify the gaps in advance. It
works on Predictive maintenance principles.
It requires, an in-depth understanding & study to predict the
situations where systems & process may be at risk and can lead to trouble. This allows us to proactively address the
situations before they become critical.
It enhances
Productivity
It is an illusion that following the cGMP Principles,
require higher cost of productivity and hence a many of the manufacturing
facilities might not strictly adhere to these.
Try to calculate the actual cost of the product against the cost incurred
on getting OOS, reprocessing etc. Are we not a loser?
If we aspire to enhance the productivity, follow the rules of
Proactive compliance, by adopting the rules of Predictive maintenance. Following Proactive compliance with CGMP is like
making “1 + 1 equals ELEVEN”.
Enhances Product
quality & credibility
Following Predictive compliance, will not only
help us in assuring a ‘Trouble free working & right Product quality’ but
also elevate our confidence levels & credibility towards working for highly
regulated markets.
ASSURE A
BETTER TOMORROW
Proactive Compliance through an established procedure at certain
defined intervals to identify the risks & gaps in the process & systems
can be the Best tool for a better
tomorrow. We require good systems & processes
with NO or least risks/deficiencies, so as to target good business markets by
being a fully Regulated manufacturing facility.
It will allow us to plan a better future and opportunities
for a vertical growth.
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