How to unify temperature compliance to minimize risks and manual work
Then you are probably missing out.
Disconnected processes can lead to redundant efforts, bottlenecks, and idle time, creating gaps where tasks can slip through the cracks.
Unifying efforts into one temperature compliance process, will not only improve efficiency but also allow you to reduce and automate traditionally cumbersome and manual domains.
Let us dive into how and why.
On this page you can explore
- How does traditional (disconnected) temperature compliance typically work?
- What is the issue with disconnected temperature compliance?
- The advantages of a cohesive compliance strategy
- How to unify temperature compliance
Dive deeper into the key regulations, compliance guidelines, and practical solutions of temperature compliance within pharmaceutical, biotech, and logistics.
How does traditional (disconnected) temperature compliance typically work?
Temperature compliance is a big part of pharma, biotech, logistics, and any other industry working with temperature-sensitive products and samples. Here is a breakdown of how the division of temperature compliance fields can* look in a typical pharma organization:
Temperature mapping is typically handled by a cross-functional team of quality assurance (QA), FM personnel, and sometimes, specialized external consultants. The QA team plans, designs, and reviews temperature mapping protocols to ensure compliance with regulatory requirements, and FM is responsible for executing the mapping study, including the placement of data loggers in the designated areas according to the protocol. External consultants are sometimes engaged to provide guidance, especially in the case of complex mapping studies.
Temperature monitoring in labs and storage facilities commonly involves both the “owners” of the facility or unit – often quality control (QC) or Quality Assurance (QA) experts or the lab technicians – and the facility management department (FM) running a Facility Management System (FMS). The unit owner has the “quality-related responsibility” and, as a result, has installed validated and calibrated data loggers to ensure quality standards. This data is archived for audits.
FM handles the technical aspects of monitoring, ensuring that deviation alerts are triggered and the system works. For this, they will typically use sensors that, while not calibrated (due to higher costs) or FDA 21 CFR Part 11-compliant, can detect system malfunctions. If issues arise, the FM first attempts to resolve them. If unresolved, QC/lab staff then consult the calibrated data to check for any quality discrepancies.
Data logger calibration
Data logger calibration plays a crucial role in making sure that the instruments are accurate and deliver reliable readings. The methodology requires a different skillset than other temperature compliance fields and is therefore normally a separate operation handled by a calibration laboratory in-house or external technicians and labs. The labs will most often be ISO17025 accredited by the national accreditation body such as A2LA, DAKKS, UKAS, etc.
*We have come across thousands of different structures, and this account consists of a simplified description of the commonalities between many of these. These fields are usually treated as separate areas, but, in reality, they are highly entwined.
4 examples of how the fields affect each other
1. Calibration and temperature mapping During a mapping, data loggers will be shipped for calibration before the start of the study, sometimes during, and again after it is finalized. This requires time, has to be coordinated with the external or internal calibration specialists, and often results in idle time and delay of the mapping.
2. Monitoring and calibration Unit owners (lab managers/QC) and FM are affected by the work of calibration technicians impacting operations continuously throughout the year due to a lack of spare data loggers that makes it unfeasible to conduct all calibrations in one go.
3. Calibration and QA To replace data loggers for calibration, QA has to perform risk assessments, which include paperwork, coordination, and time.
4. Temperature monitoring and mapping Temperature mapping paves the way for efficient monitoring since the findings from the study can (and should) be used to define where monitoring data loggers should be located as well as the necessary amount. Often findings from a temperature mapping study will also define operational restraints and optimizations for operational teams.
And so on.
6 ways to spend less time on manual temperature compliance
There are ways to make temperature compliance much simpler and less time-consuming.
This guide outlines how.
What is the issue with disconnected temperature compliance?
Historically, mapping, monitoring, and calibration have been handled separately for well-founded reasons: Each field has required unique expertise, which has made it tricky or even impossible to consolidate them.
But when these critical compliance and quality areas operate in silos, the risks multiply. In a scenario where these functions do not communicate effectively, a range of (unnecessary) challenges usually follows:
9 issues that split temperature compliance can cause:
- Bottlenecks: Differing focuses, goals, and a lack of communication lead to the different departments becoming bottlenecks for each other, and temperature compliance being seen as an obstacle to business decisions and growth.
- Complex processes: Designing efficient quality procedures becomes extra complex because of the many stakeholders to consider.
- Responsibility confusion: Who is on first? When functions are segregated, responsibilities become unclear. This confusion often leads to tasks being overlooked or duplicated. All the parties involved make it difficult to ensure a cohesive approach across the business leading to inconsistency.
- Idle time: Since calibration is managed as a separate process, alignment issues often lead to costly periods of inactivity during mappings.
- Daily disruptions: Interruptions occur between the various functions – often because of misalignment. For example, calibration disrupts activities in the lab or unit.
- Frustration with “irrelevant” tasks: Although lab personnel take compliance obligations seriously, for many, the tasks are not within their professional interest.
- Unnecessary costs: When it comes to paying the bill for data loggers, calibrations, alarm systems, and other services needed, each department is responsible for its own piece of the pie. This often results in an unnecessarily high, and untransparent, price tag.
- Deviations: With separate systems, deviations can go unnoticed or unaddressed. This lack of coordination can lead to compliance issues.
- Audit issues: Auditors expect cohesive, comprehensive data. Disjointed systems make providing this a Herculean task.
This is why we believe that the future of temperature compliance gathers mapping, monitoring, and calibration in one, connected process – which, of course, is the foundation of our temperature compliance solution.
Handling temperature compliance in unison comes with multiple advantages, for instance:
How to unify temperature compliance
However, combining all the functions working with temperature compliance into one wouldn’t work for most organizations. Next to this compliance work, each department has a range of other responsibilities that do not necessarily intertwine.
Instead, it is about seeing validation, data logger calibration, and temperature monitoring as integral parts of one comprehensive temperature compliance strategy.
So, how do you do that?
The very, very quick version: 1. Align with all relevant stakeholders to create a shared understanding of the need for alignment. 2. Identify overlapping areas in workflows to reduce bottlenecks and redundancies and establish shared goals. 3. Promote and make room for collaboration across departments. 4. Assess digital solutions for their potential to support a unified temperature compliance effort – more on this below.
This will make it simpler to develop an effective, time-saving, and risk-reducing process across the field. Easier said than done, we know. But even small efforts can make a difference.
Are you ready to streamline your temperature compliance process? Consider a unified solution that brings mapping, monitoring, and calibration together. Avoid the chaos and stay ahead in the game of compliance.
Learn more in the temperature compliance guide
If you want to dive deeper, one of the strategies in our guide to spending less time on manual compliance highlights the 7 steps to aligning temperature compliance.
Can an all-in-one temperature compliance solution fix it for you?
Not completely. But, even though there is no way around the need for a bit of internal alignment, there are shortcuts to unifying your efforts.
One of the most effective ones is introducing a temperature compliance solution that combines them. Merge both temperature monitoring, mapping, and calibration into one, remove gaps, and allow digitalizing – and therefore easy exchange – of data across teams and locations.
5 things to look for in a temperature compliance solution
Dive into the details of the temperature compliance solution, what to look (out) for, and the issues it can solve.
What we have learned
Performing mappings, monitoring temperatures, handling deviations, reporting for audits, and calibrating data loggers: Considering them all parts of ONE compliance process is the direct route to reducing the cumbersome nature of traditional temperature compliance.
Handling these elements in unison enhances operational efficiency, ensures compliance, and provides a comprehensive overview of the temperature-controlled environment.
A few places to learn more
Talk to a compliance specialist
Feeling swamped by regulations? We are here to help. Book a (free) 15-minute consultation with a compliance expert.
Watch learning sessions
Dive into our educational videos, covering everything from 21 CFR Part 11 for temperature monitoring to methods to automate your temperature compliance processes.