Top 8 Pitfalls of Using Excel for GMP Audits in 2024 (and How To Solve Them Faster)
No Food & Beverage Manufacturer (F&B) ever wants to be questioned for lacking in quality, especially if they are producing at scale. Scathing public boycotts and losses are almost just one viral review presently. This makes Quality Management in the F&B industry a sensitively regulated and monitored business process, which demands third-party reviews for quality, health and safety.
Hence, F&B manufacturers must comply with local regulations - like the EFSA in Europe, FSSAI in India, and the FDA in the United States. Good Manufacturing Practices (GMP) frameworks are a large part of those regulatory activities - which must be trailed by producers, controllers, and retailers to continue operating in a region with legal food safety certifications. And for companies, the GMP programs are needed to prevent food safety hazards from occurring.
As a result, companies will tailor their quality standards based on the products they make and the markets they serve in that region, using GMP audits - that assess a company’s GMP. However, food regulations and standards evolve over set periods and also vary by country.
Good Manufacturing Practice (GMP) audits are critical in ensuring manufacturers comply with quality standards designed to minimise risks involved in production. Quality Managers are in charge of maintaining GMP audits’ consistency across production sites for a company, all their related data, periodic reports, workflows, and ad-hoc audit changes if traditional hard-coded GMP tools can’t accommodate their unique workflows.
However, when we spoke to several bottling companies recently, we were surprised to discover that they are using hundreds of spreadsheets to manage GMP audits. But why is this happening?
The State of GMP Audits - The Rigidity Of Traditional Tools
In the food and beverage (F&B) industry, GMP (Good Manufacturing Practice) audits are essential for ensuring compliance with health and safety standards. Many F&B businesses end up with traditional GMP audit tools, which lack flexibility and adaptability. These tools are often hard-coded and do not accommodate situation-based workflows or process-specific GMP requirements of a company.
This rigidity can hinder effective quality management, as companies must adapt their processes to the tools rather than the tools adapting to their processes. The need for a more flexible solution leads many to turn to alternatives like Excel spreadsheets.
Why Excel Becomes a Seemingly Reliable Alternative for GMP Inspections
Excel is often the go-to tool for managing GMP audits because it is readily available and adaptable. It allows for ad-hoc additions and modifications of GMP audit items, catering to the specific needs of a company at any given time. This flexibility is particularly appealing in an industry where regulations and standards frequently change. However, while spreadsheets offer maximum agility, there are many pitfalls
Pitfalls of Using Excel Sheets for GMP Audits
1. Lack of Real-Time Collaboration
Excel struggles with real-time collaboration. Teams cannot work on the same document simultaneously without running into version control issues, leading to discrepancies and data mishandling - and then subsequent manual sorting of data. This limitation is a significant setback during audits where timely and synchronised data entry and updates are crucial for accuracy and compliance.
2. Error-Prone, Manual Data Entry
Manual data entry in Excel is highly susceptible to errors. Whether it is miskeying of data, formula errors, or accidental deletions, each mistake can lead to significant issues in compliance and audit accuracy. The manual nature of the process also increases the workload and stress on staff, potentially leading to further errors and inefficiencies.
3. Inadequate Security Features
Excel's security features are not designed for sensitive data management, which is a core component of GMP audits. Basic password protection does not safeguard against breaches or unauthorised access, posing a risk to confidential company and compliance information.
4. Limited Audit Trail Capabilities
Tracking who changed what and when in an Excel spreadsheet can be incredibly challenging, as it lacks comprehensive audit trail capabilities. This limitation makes it difficult to ensure accountability and trace data modifications, which are critical for maintaining audit integrity and compliance.
5. Scalability Issues and Chaotic Version Control
Excel is not well-suited for scaling up with the business. As data volume grows and more users need to access and manipulate the spreadsheets, performance can significantly decrease, leading to crashes and data corruption. Quality managers often find themselves spending excessive time configuring and reconfiguring spreadsheet versions to meet the reporting requirements of different audits, a process that is both time-consuming and prone to human error.
This scalability issue is a critical drawback for growing companies.
6. Dispersed and Siloed Data
The use of multiple Excel files to manage different aspects of GMP audits can lead to information silos and disconnected files. Data becomes even more difficult to access for reporting. Without a single source of truth, consolidating data across multiple spreadsheets leads to more time drain, often resulting in a fragmented view of audit outcomes and complicating compliance verification.
7. Difficulty of Using Excel in Mobile Devices
The interface, primarily designed for desktop use, does not translate well to smaller screens, making navigation and data entry cumbersome and error-prone. Additionally, Excel’s features are limited on mobile versions, which restricts functionality essential for comprehensive audit management. It is not practical or safe to walk around a production plant with a laptop in hand.
8. Lack of Efficiency in Image uploads
Integrating images into Excel sheets is not only non-intuitive but also inefficient, particularly during GMP audits where visual evidence is frequently necessary to document compliance or highlight issues. The process of uploading and managing images in Excel is cumbersome, as the platform does not support direct embedding or easy manipulation of images. Users must often resort to linking or inserting images as separate objects, which can disrupt the layout and readability of the data. This limitation severely hampers the audit’s effectiveness, as visual data can be as crucial as numerical data in ensuring thorough quality control and regulatory compliance.
How to Make GMP Audits Faster with NoCode Platforms like Softools
What if the disconnected and manually handled Excel spreadsheets with precious GMP data got transformed into a NoCode app within minutes using Softools? Or if you used our ready-to-deploy GMP app which you can customise with your own questions
At Softools, we have a plethora of use cases alongside GMP and GWP audits such as CAPA, checklists (e.g. Sanitisation), RCA/BDA, Document Management and Change Management that are all easily modifiable with our No Code configuration.
Digitise Checklists Instantly
Softools enables the quick digital transformation of audit checklists. This feature allows quality managers to set up and modify checklists with ease, making the setup process and any subsequent changes fast and efficient. Unlike traditional methods, which require time-consuming manual adjustments, digitising checklists on a NoCode platform ensures that audits can be updated in real time, reflecting new regulations or customised requirements instantly.
On-the-Fly Customisation
One of the key advantages of using Softools is its ability to adapt on the fly. Audits are not static; as findings are gathered, and circumstances change, the need to adjust audit parameters can arise. Softools allows users to make these adjustments during the audit itself, without significant downtime or disruption. This flexibility ensures that audits are always aligned with the most current data and practices.
Email Notifications
Staying informed during the audit process is critical for maintaining compliance and ensuring that all team members are on the same page. Softools enhances communication through automated email notifications. These notifications alert users about updates, changes, or completion of tasks within the audit process. This feature ensures that all team members are promptly informed, which is crucial for timely decision-making and maintaining workflow continuity.
100% Data Visibility in Real-Time
In the realm of GMP audits, having access to comprehensive, real-time data is invaluable. Softools offers a unified platform where data from all facilities is centralised and made accessible through easily navigable dashboards. This real-time visibility ensures that quality managers and auditors have a 360-degree view of the audit landscape at any moment, enabling better oversight, quicker responses to compliance issues, and more informed decision-making.
Softools allows you to preserve your legacy system’s data and free it from all the silos into a single central source of truth.
When it comes to making your GMP audits faster and even more time-efficient, Softools equips you with the most flexible platform to help you build your unique solution in record time.
Don’t believe us? Just reach out to us at the link below for a demo and we’ll show you the Softools GMP app in action!
Run your GMP Audits on any Device
Softools is device agnostic and offers offline capability so that your digital solution is always functioning, no matter where you are, even in the remotest parts of your facilities. Imagine conducting a whole GMP audit without having to carry your laptops or papers across your production plant. We just made audits fun again.
Bulk Upload Images Within the Audit Process
If you are using Softools to digitise your GMP audits, you don’t have to worry about the tedious uploading of individual single file attachments on Excel. You can add relevant photos and visual evidence from within the GMP app without having to leave the audit process. At scale, if you have multiple production facilities, individual image uploads can impose a heavy cost of time.