Are Logbooks still Relevant in Pharmaceutical Organisations?
Over last few years, we have been working as a business partner with pharmaceutical organisations as Continuous improvement trainers, coaches, and mentors. As such, we coach people at all levels of the organisation in how to apply Lean Thinking to achieve improvement. In many respects, the types of issues that we train, support, and coach people are the same as in most offices and factories.
But there are some areas that are unique to the Pharma industry. One area where our coaches have had a lot of successes through our LeanEssentials training is making the compliance-related process more efficient. In this training, we give participants a one-day experience in a lean business simulation to learn the Lean Principles. Then we coach and mentor them on how to undertake an improvement project related their work. Next, they present this project to senior management.
Logbooks in Pharmaceutical Organisations
The use of logbooks is a recurring theme in our coaching and mentoring assignments. From a Lean perspective, they are a potential area for waste elimination as much of the information recorded is often duplicated in other systems.
In fact, it is often the organisation of the logbooks themselves that is a cause of waste. Sometimes they are placed in central stores away from where the work takes place or in unstructured libraries leading to lost time searching for information.
This got us to thinking about the pros and cons of logbooks in pharmaceutical organisations, and whether they still have a place in this industry?
What is a Logbook?
In the pharmaceutical industry, accuracy, compliance, and safety are paramount. Indeed, the use of logbooks is a long-standing practice. They are written records that document the activities, observations, and results of various processes and procedures. Examples of these include laboratory experiments, clinical trials, manufacturing operations, and quality checks. However, with the use of digital technologies and data management systems, are logbooks still relevant in 2023?
Benefits of using a Logbook
Traceability
Logbooks provide a clear and chronological record of what was done, when, and by whom. In addition, they help to track the progress, deviations, and errors of a process or project. They enable a quick and accurate identification of the root cause of a problem or a failure. In particular, this is important in the pharmaceutical industry, where the source and quality of every ingredient, sample, and product must be traceable and verifiable to ensure patient safety and regulatory compliance.
Compliance
Logbooks are often required by regulatory agencies. These include the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as part of the documentation and reporting obligations for pharmaceutical companies.
By using logbooks, organisations can demonstrate their adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other standards and guidelines. This can help to avoid penalties, fines, and legal actions, and ensure the reputation and trustworthiness of the company.
Accountability
Logbooks hold individuals accountable for their actions and decisions. By signing and dating a logbook entry, an employee acknowledges the accuracy and completeness of the information provided. He/she assumes responsibility for any consequences that may arise from it. This promotes a culture of transparency, integrity, and professionalism, and reduces the likelihood of unethical or illegal behaviour.
Knowledge Management
Logbooks can serve as a valuable source of information and knowledge for future reference and learning. Moreover, they capture the insights, best practices, and lessons learned from a process or project. In addition, they enable the transfer and retention of this knowledge across generations, teams, and locations. Therefore, this can improve the efficiency, quality, and innovation of the organisation, and foster a culture of continuous improvement.
Issues with Logbooks in Pharmaceutical Organisations
Reliability
Logbooks and other forms of manual record keeping can be subject to human error, bias, and misinterpretation. Firstly, handwriting, spelling, and grammar mistakes, as well as inconsistent or incomplete entries, can compromise the accuracy and reliability of the information. Second, logbooks can be lost, damaged, or tampered with, either intentionally or unintentionally, leading to data loss or corruption. As a result, this can undermine the trustworthiness and credibility of the organisation. To counter this, additional processes and resources are sometimes initiated just to ensure record keeping is managed to an acceptable standard. However, this runs counter to the First Time Right approach we aim for in Lean Operations.
Accessibility
Logbooks can be difficult to access, share, and analyse, especially when they are stored in physical form or in disparate locations. In addition, they can also be time-consuming and costly to transcribe, digitise, or integrate into a digital system. This can limit the speed, flexibility, and scalability of the organisation, and hinder its ability to make informed decisions and respond to changing needs.
Repetitiveness
Logbooks can be seen as a repetitive and low-value activity by some employees. Actually, they may perceive them as a bureaucratic or administrative burden. This can lead to a lack of engagement, motivation, and creativity, and contribute to a culture of compliance rather than innovation. Also, logbooks may not capture the tacit knowledge, intuition, and expertise of the employees, who may rely on informal or oral communication to share and learn from their experiences.
Cybersecurity
Logbooks that are stored in a digital system or cloud can be vulnerable to cyber threats such as hacking, malware, ransomware, and data breaches. Likewise, this can expose the sensitive and confidential information of the organisation. This can include patient data, intellectual property, and trade secrets. Moreover, logbooks that are not properly encrypted, backed up, or archived can be lost or corrupted due to system failures, power outages, or natural disasters.
Consequently, this can disrupt the continuity, reliability, and availability of the information, and compromise the compliance and safety of the business.
So, do Logbooks still have a Place in Pharmaceutical Organisations?
Despite the potential drawbacks and challenges of logbooks, many pharmaceutical organisations still rely on them as a critical tool for quality assurance, regulatory compliance, and risk management. Logbooks provide a tangible and auditable record of the activities and decisions made by the employees. In fact, they serve as a primary source of evidence in case of audits, inspections, or legal disputes.
Moreover, logbooks can complement and reinforce digital technologies and data management systems. They provide a human-readable, context-rich, and holistic perspective of the process or project. By using logbooks alongside digital systems, organisations can leverage the benefits of both worlds, and optimise the accuracy, reliability, accessibility, and security of their information.
However, to fully realise the potential of logbooks, pharmaceutical organisations need to address some key issues and best practices.
Best Practices for Logbooks
Standardisation
Logbooks should follow a standardised format, language, and structure, to ensure consistency, clarity, and comprehensiveness. This can facilitate the comparison, analysis, and interpretation of the information. Also, it can avoid confusion, errors, or misinterpretations. From a Lean perspective each operation in the company needs to be part of a standard work system. Often when replacing or augmenting logbooks we coach people to design forms and systems that capture the information in the simplest possible structure.
Training
Employees should receive adequate training and guidance on how to use logbooks effectively and efficiently. Furthermore, they need guidance on how to adhere to the relevant regulations, standards, and guidelines. This can improve their understanding, motivation, and performance, and ensure the accuracy, completeness, and compliance of the information. Team training is an essential part of any Lean operation. Many of the projects we coach involve a process to ensure that team members are qualified in Standard Work.
Verification
Logbooks should be regularly reviewed, verified, and validated by authorised personnel. This is to ensure accuracy, completeness, and reliability. To clarify, logbooks can detect and correct errors, omissions, and inconsistencies, and improve the quality and trustworthiness of the information. Many of the solutions and improvements we have coached involve making the data entry system sensitive to errors and omissions. Simple things like catching a variable that is out of the standard range or preventing a key document being saved with omissions.
Integration
Logbooks should be integrated with digital systems, where feasible and appropriate, to enable seamless data exchange, analysis, and reporting. This can reduce the duplication, fragmentation, and inefficiency of the information, and improve the speed, scalability, and agility of the organisation.
We have coached many people who are working to digitise their compliance tasks record keeping. In our experience, we recommend a phased approach. This is where the learning from pilot projects and successes in one area are transferred to the next phase.
Conclusion
In our view, we think that logbooks still have a place in pharmaceutical organisations. However, this is provided they are used in a standardised, trained, verified, and integrated manner. In addition, they need to be complemented by digital technologies and data management systems. By optimising the benefits and addressing the challenges of logbooks, pharmaceutical organisations can ensure the compliance, safety, and innovation of their operations.
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