How do you prepare your temperature mapping processes for audits?
What auditors expect from your mapping procedures - and how to deliver it
Audits can be time-consuming and stressful. How do you ensure your thermal mapping process stands up to inspection?
Temperature mapping is a key focus of thermal compliance audits, but successful audits take more than completed mapping studies – it takes good documentation, clear rationales, and properly utilized mapping findings.
This article outlines what auditors will most often expect from your temperature mapping activities, from rationale, documentation, and risk assessments to re-mapping strategies
Also read: What auditors expect from your temperature compliance program
This guide covers:
Note!
This guide provides general guidance and does not guarantee the outcome of your audit. Evaluate all recommendations based on your own risk assessment in the context of your specific operation.
Design rationales
When audit findings occur on the basis of temperature mapping, it often stems from vague or undocumented decisions. As such, it is not enough to just perform a mapping; you must also justify your design choices. Your rationale should show how the study setup was tailored to your actual storage environment, operation, and requirements.
Some of the key rationals to include are:
- Defined objectives based on storage or transport requirements
- Number and placement of sensors based on risk and volume
- Reference to product characteristics and sensitivity to temperature
- Mapping duration and environmental conditions justified for the use case
- Selection criteria for sensor type, accuracy, and calibration
- Clear [protocol(/temperature-mapping/protocol/) covering deviations, calibration, and acceptance criteria
- How results will be evaluated and applied to operations
- Documented roles and responsibilities for planning and execution
- Evidence of staff training on mapping procedures
Where to include the rationales?
The reasoning behind study design decisions should be included throughout your protocol.
Also read: How to create a temperature mapping protocol in pharma
Based on your specific mapping protocol structure, you can include the different rationales in the following sections:
- Purpose: Include a high-level justification for conducting the mapping, tied to your validation strategy and product and process needs.
- Description of the unit: Explain the physical setup and environmental context, including layout diagrams that can be used to describe sensor placement.
- Scope: Define what areas and conditions are included, with rationale for why they are part of the study. Consider your usable volume, which is not necessarily the entire space. This will show auditors that you understand your operation and can make a risk assessment based on your specific operation. At the same time, it will also often mean that you can limit the number of data loggers needed, making the study more cost-effective.
- Objectives: Clearly state what you aim to demonstrate or evaluate and why, linked to your specific products and storage risks.
- Risk assessment: Document identified risks that influence mapping decisions, why these are considered risks. Also read: Guidelines for risk-based temperature mapping in GxP
- Methodology: Provide a detailed explanation of how sensor placement was determined, based on the rationale from previous sections.
Also read: Where to place data loggers during temperature mapping?
Re-mapping strategy
Within traditional mapping, you must conduct repeated re-mapping at defined intervals based on your risks and process changes - and auditors will often ask how these intervals are determined.
Create a written policy defining mapping frequency based on risk assessments and how this frequency will be maintained across units, facilities, etc. Use of change logs and quality reviews to reassess mapping needs. Also include the triggers that warrant re-mapping outside the normal frequency, e.g., equipment changes, layout updates.
Tip! Make sure to prepare examples of past re-mappings and their rationale. Concrete examples are often the best way to showcase actual compliance.
Also read: Continuous temperature mapping: A framework to eliminate re-mapping
Tip! Eliminate re-mappings with CONTINUOUS temperature mapping
No more re-mappings. Constant compliance. Reduced costs. See how it works in the product catalog.
Risk-based decisions
The risk-based approach is becoming the mapping standard in pharma logistics, manufacturing, and other highly-regulated industries. In the short version, risk-based temperature mapping means basing your mapping strategy on a thorough risk assessment and not strictly following external guidelines (although these can work as a starting point).
This risk assessment should justify the scope, number, and placement of sensors, frequency, etc. As such, auditors will often look for your strategy to be based on your actual operational, regulatory, and technical risks.
Also read: Guidelines for risk-based temperature mapping in GxP
Making use of your mapping results
Your mapping results should inform your temperature monitoring setup and procedures, and auditors will often check how your findings were used. In other words, make sure to use mapping findings to optimize your processes and workflows – and, of course, document why and how you did so.
Potential element to update based on your mapping findings:
- Sensor placement for monitoring
- Alarm thresholds and monitoring frequency
- Standard operating procedures (SOPs)
- Identification of unsuitable areas for storage
- Content and procedures for training your team
Protocol design and execution
A well-designed protocol is the foundation of a successful temperature compliance audit. It shows auditors that your study was intentional, controlled, and repeatable. Make sure to include defined roles, objectives, and acceptance criteria.
The protocol typically contains several sections covering everything from roles, purpose, and scope to risk assessment, methodology, and more.
You can learn all about how to design a mapping protocol in pharma logistics
Documentation and traceability
Clear, complete, and controlled documentation is one of the strongest audit defenses. Each step in the mapping process should be traceable, including but not necessarily limited to:
- Approved mapping protocols and reports
- Calibration certificates for all data loggers used
- Mapping findings and subsequent changes to the operation
- Version control on all related documents
Checklist: Audit-ready temperature compliance in GDP
What do auditors look for in your temperature compliance (monitroing, mapping, and calibration) processes in GDP? Download the checklist based on GDP guidelines.
Common audit pitfalls in mapping
Many audit findings stem from avoidable oversights. Watch out for these common gaps in mapping execution and documentation:
- Vague or undocumented mapping rationales
- Relying on default frequencies instead of risk assessments
- No real-time checks during mapping execution
- Failing to act on mapping findings
- Using non-calibrated sensors
Checklist: Temperature compliance audit checklist for GMP
Get the free checklist covering the areas auditors often look at during audits in GMP.
FAQ about audit preparation in temperature mapping
Often asked questions - and their answers - about audit preparation of your temperature mapping processes.