9 thermal mapping

mistakes to avoid
Temperature mapping is more than a regulatory obligation; it offers a
chance to continuously enhance your procedures. However, it is also
prone to errors that can be both costly and time-consuming.

So what are the common mistakes – and how can you prevent them?
01 Protocol

Protocol
What can go wrong
during planning?

1
Failing to involve the right people
Not including all stakeholders in planning.

How to avoid it
Temperature mapping is more about people than science – so bring the right
people to the table. Involve both Operations, Quality, management, and
potentially also customers.

2
Not planning ahead
No matter how well-structured your protocol is, it
won’t matter if your plan is unrealistic.
Have you experienced that a
mapping took longer than planned?
How to avoid it
Create a realistic plan by: Yes 78%
● taking available people and approval time into
account.
● ensuring all parties agree on process steps and No 21%
timeline.
● stabilizing the unit before taking measurements.
● getting approval from the quality unit for each Poll taken during “Things that can go wrong during a
step before moving forward. thermal validation” webinar, February 2023

3
Not accounting for (all) risks
It is common for risk categories to be overlooked.

How to avoid it
Do a risk assessment based on:

● Compliance risks: Regulatory requirements and the standards to follow. At Eupry, we

mainly base our assessment on WHO and ISPE standards.
● Technical risks: Risks caused by machinery, heating systems, or other technical
installations.
● Operational risks: Risks prompted by personnel working in or near the facility or unit.

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02 Execution

Execution
What can go wrong during
the mapping?

4
Lack of GDocP training
Not training everyone in good documentation practice (GDocP) can lead to
inaccurate documentation, misplacement of loggers, and costly
measurement redos.

How to avoid it
The simple answer is:
● follow GDocP (ALCOA+ principles).
● train everyone involved in the mapping – from the people setting up
data loggers to the facility managers.

No ongoing data monitoring

5
The time of the USB data logger is over. Yes, we said it.
If you don’t continuously monitor data during the study Have you discovered equipment not
you risk discovering non-compliant or failed equipment passing requirements after a
after the test is over, which can result in delays, cost mapping was completed?
spikes, and a need for retesting. Yes 68%

How to avoid it
No 31%
● Do a pre-qualification: Test environmental
parameters against predetermined limits before
the study. This lets you configure equipment if it
Poll taken during “Things that can go wrong during a
does not meet the limits.
thermal validation” webinar, February 2023
● Choose the right equipment: Go with
equipment that allows live data monitoring to be
able to act on issues right away.

6 Failing to inform the on-site team

If people on site aren't properly informed of the mapping, your test could be disrupted.

How to avoid it
Inform all involved personnel about the plan, and keep open communication with the
operational team and quality unit to minimize interruptions and prevent undocumented
non-conformities.

02
03 Follow-up

Follow-up
What can go wrong during
reporting and follow-up?

7
Missing review of documentation
Not reviewing the documentation throughout the process can result in
invalid data, misguided conclusions, and time delays.

How to avoid it
Make sure collected documentation is reviewed after each step of the
process by the people doing the analysis. This gives you a real-time
overview, lets you spot and enrich lacking documentation along the way,
and (potentially) redo deficient measurements.

8
Neglecting deviations and changes
At the end of studies, many companies fail to follow up on changes that happened
from the time the protocol was approved to the execution took place and deviations
to the protocol.

Insufficient analysis of these can result in inaccurate reporting, since root causes
may be overlooked.

How to avoid it
A few ways:
● Avoid excess time between protocol approval and mapping to limit changes.
● Update the protocol when changes happen before mapping.
● Assess and document changes and deviations after mapping.

Tip: Review all relevant documentation, including materials beyond the mapping
scope such as camera footage, log books, etc. Being able to document that you have
handled deviations responsibly will result in a more credible report.

03
03 Follow-up

9
Not using findings
One point of thermal validation is to pinpoint hot spots, cold spots,
and other places in the facility to be aware of and to place
monitoring data loggers. But it frequently happens that the results
are not utilized to update processes.

How to avoid it
Utilize the results to:
● define the best positioning of monitoring data loggers.
● update procedures to account for results differing from existing
protocols.

More information about mapping?

This overview is based on our webinar on errors in thermal validation. Watch it
here for a more detailed walkthrough.

You can also read more about temperature mapping (what it is, why it’s
important, and how it’s performed) on our website right here.

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