CQ Guide: Ultimate Guide to Safety Management at Life Sciences Companies

Why a Safety-First Approach is Critical?

Life sciences is one of the most regulated industries across the world – both in developed as well as in developing countries. Companies across the life sciences sector including medical device manufacturers, pharma, biotech, biomedical technology, and healthcare services companies are facing several challenges in meeting compliance requirements, ensuring employee safety and reducing recurring injuries.

Health & safety (H&S) leaders need to ensure that all OSHA and other safety compliance requirements are being followed. In addition to general workplace safety guidelines, it is also important for life sciences companies to plan safety precautions against the use of hazardous chemicals, biological hazards, etc.

As per a report published by OSHA, some of the often-reported risks to employee well-being in the life sciences industry are from the following areas –

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  Usage of flammable and combustible materials
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  Presence of hazardous chemicals in the lab
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  Biological hazards, risks of unknown biomaterials
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  Musculoskeletal strains due to poor ergonomics, repetitive movements, and/or awkward working positions
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  Other lab safety hazards (sharp glass, etc.)

Of course, by implementing a robust Safety Management System (SMS) most of these risks can be proactively identified and mitigated with a data-driven safety management process that is proactive, preventive, and reactive – all together.

But that is easier said than done. While embracing automation and digital transformation is critical to improve safety performance – getting it right is not easy.

The 'Connected' EHS

In 2019, an Ernst and Young article pointed out that EHS professionals have been slow in embracing and adopting digital technology, primarily because organizations were unable to grasp fully the nature of problems they are trying to solve in the health and safety domain.

According to the article, even when technology was implemented, it was usually “disconnected” from other business systems and was designed to tackle isolated safety issues.

However, over the last three years, there has been an acceleration in the adoption of digital tools and technologies. The pandemic and the need for remote work certainly accelerated this trend. For health & safety (H&S) leaders, this provided the necessary impetus to get buy-in from senior management leaders to invest in digital transformation and automation of EHS processes and workflows. For instance, if a safety audit had to be completed while working remotely, it would be impossible without digital transformation.

At ComplianceQuest, our product management and solution teams have worked closely with numerous safety leaders – including several of them from life sciences companies. Through the experience of implementing ComplianceQuest at several life sciences companies – we’ve learnt that the following factors play a key role in successful digital transformation efforts:

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  The right technology solution is critical: The need of the hour is to implement a cloud-based EHS solution that is flexible, scalable, and configurable. The solution must seamlessly integrate with the EQMS, ERP, and CRM, so there is a free flow of real-time data and information across the organization.
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  But, that’s only the beginning: Choosing the right EHS is only the first step. Every organization is different and the safety leaders must adopt a collaborative approach with relevant stakeholders to design a robust H&S process. Right from tracking near misses and safety observations to handling incidents, risk mitigation initiatives, conducting audits and inspections – an end-to-end process flow must be designed.
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  Safety is critical across all departments: In the life sciences sector, for instance, lab safety processes as extremely critical. It is also critical to ensure safety processes are being followed right from the research phase, till the time the product hits the end user.
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  Culture, Culture, and Culture: End of the day, we witness unsafe behavior at the workplace because people haven’t had the right training or because they don’t have a safety-first mindset. The key is to use a top-down approach to communicate the organization’s commitment to employee well-being and workplace safety.
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  Rally your troops together: The only way to reduce safety risk is by proactively eliminating risky processes or unsafe behavior displayed at work. Total Employee Involvement (TEI) is the key to increasing safety performance.
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  Spot problems, set goals, and have a well-documented safety strategy: The H&S team must work closely with functional heads and the executive leadership and put together a safety management strategy that spans reactive, preventive, and proactive approaches to safety risk management.
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  Execute this strategy to the tee with continuous improvement: By bringing together people, processes, and systems, it is possible to bring down incident rates and pursue safety excellence.

In this CQ Guide, we offer a structured approach to safety transformation at life sciences companies – one that is participative, holistic, collaborative, and data-driven.

Transforming to a Safety-First Approach

Safety Transformation should be planned out properly due to the cost, time, and operational implications. A badly implemented safety management system can have only a limited impact and may soon be abandoned due to its ineffectiveness. While digital transformation is essential in today’s world of greater awareness about workplace safety and stringent regulations — a systematic approach is just as important.

The 10 steps a business must follow for a successful transformation include:

Step #1 – Assess Current State: The safety team must audit the current state of safety processes across all locations and/or manufacturing facilities. The level of safety awareness and implementation of safety processes may be different in different locations. These need to be identified and documented to create a standardized policy that can help locations that are lagging behind come up to speed. Often, safety may look good on paper though it may be far from the truth. Therefore, visiting these units and interacting with the employees is a must to get an accurate picture.

A robust audit and safety inspection process is key to this assessment. Have open conversations and brainstorming sessions, in addition to gathering information. This will help while setting safety goals and planning initiatives. It’ll also help the safety team uncover unexpected risks.

Step #2 – Analyze Documents, Data, and Reports: Another aspect of safety audits is to evaluate the current status of safety documentation. Often, in the hurry to meet their deadlines, reporting and documentation may have been ignored. It adds to the administrative burden and is hard to track and follow up.

As the safety transformation process starts, plan to implement a robust document management system, so it will be easy to access all safety-related documentation. Ideally, this must be integrated with your EHS system.

For instance, in the life sciences sector, it is paramount that all Material Safety Data Sheets (MSDS) are up to date. MSDS is a master document with information on the potential hazards of the chemicals and how to handle them safely. It forms the foundation for the health and safety program in a laboratory detailing the correct usage, storage, handling, and emergency procedures for hazardous materials. Prepared by the supplier or the manufacturer, it is much more than a label, acting as a guide to prevent events or handle them effectively in case of one.

Step #3 – Define Safety Policy and SOPs: Often, the lack of standardization is one of the reasons for the disparities in safety levels in different departments and sites. Creating a comprehensive policy and sharing it with the entire organization along with sufficient awareness creation through posters and other visual tools will reinforce the need for safety processes to be followed by all employees.

For instance, there must be SOPs on how inflammable material should be identified and stored in fireproof cabinets. They should always be placed back in the cabinet after use and not left lying around. Bunsen burners and other hot surfaces should be handled with care. Following instructions when producing substances with explosive properties are important. The fire extinguisher should be kept handy and the staff must be trained to use it.

Step #4 – Lead from the Top, But Involve the Entire Organization: When the management is serious about safety and takes interest in ensuring correction and prevention of incidents, it reassures employees and encourages them to imbibe safe behavior. The truth is: safety-first has to become the norm, with every employee contributing towards making the workplace safer.

When senior leaders work closely with the H&S team to understand the real value of investing in safety management, meaningful change will happen. As the EY article mentioned, it is not about implementing an EHS system and expecting magical results. Safety goals will be met, only when people truly come together and proactively spot risks and put control measures in place.

Step #5 – Lab Safety Measures – Design Robust Systems and Processes: The laboratory can be a highly unsafe place in the life sciences industry due to the use of chemicals and biological hazards. Therefore, the Occupational Safety and Health Administration (OSHA) recommends making the labs safe by:

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  Frequently clean it to clear chemical hazards and particles
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  Periodically wash hands to prevent the spread of bacteria, viruses, or hazardous chemicals
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  Avoid consuming food or water in the lab
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  Do not smoke inside the laboratory
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  Ensure availability of and use of Personal Protective Equipment
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  Appropriately label containers
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  Periodically check the proper functioning of equipment
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  Wear a head cap to prevent contamination through hair
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  Remove clutter and loose wires to avoid trips, falls, and electric accidents
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  Clean spills immediately
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  Evaluate risks every day

Step #6 – Training Management: Another way of showing commitment to workplace safety is to train employees in the necessary skills to discharge their responsibilities safely and effectively.

Most people see safety training as a chore. But it is critical to get the message across. Efforts must also be taken to reinforce and emphasize on the need for practicing safety, and risk-aware behavior.

For instance, OSHA in association with CDC has published a set of guidelines to dealing with infectious diseases in hospitals and other locations. Here’s a sample list of some of the key guidelines published:

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  Take steps to ensure hand hygiene
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  Plan isolation rooms and take precautions to prevent the spread of infectious diseases
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  Ensure healthcare workers including nurses are taking precautions as they meeting several patients in a day
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  Ensure medical devices are sanitized properly to prevent the spread of infections

At the end of the day, for all of this to happen, training is critical.

The other four steps are:

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  Measure Both Lagging and Leading Indicators: Progress needs to be measured. Therefore, it is important to identify key performance indicators and the metrics that indicate the effectiveness of the safety processes.
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  The Risk Management Lifecycle: “If you don’t invest in risk management, it doesn’t matter what business you’re in, it’s a risky business,” says Gary Cohn, the Vice Chairman of IBM. Businesses must be able to proactively identify potential risks by running a robust risk assessment process. Rating the risks based on frequency and severity will help to prioritize the risks that need to be addressed first.
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  Empowering Employees: In addition to training the employees in safety processes, it is also important to empower them with the tools needed to report observations, near misses, and incidents without fear of retribution. Since the safety team cannot be everywhere, employees act as the eyes and ears in their functional areas, thus participating proactively in making the workplace safe.
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  Audits and Inspections: Periodic audits and inspections are crucial to identify potential and current risks. They can be conducted by internal or external auditors. Running a data-driven audit process with relevant documentation can make a huge difference to make safety improvement an ongoing priority.

Better Automation, Better Safety

The gaps have been identified, policies and processes established, and employees made aware of the importance of and their role in safety management. Next, businesses must assess digital tools suited to their organization to effect a digital transformation of safety management in their organization. There are many options available in the market and it can be confusing.

A good digital safety management system should be cloud-based, to facilitate collaboration across geographies and minimize the cost of the solution. It should align with the leading and applicable regulations and standards so that keeping pace and making changes becomes easier. It should be modular so that businesses can choose their modules they need based on their priorities.

Further, the solution should enable businesses with reacting to events and incidents quickly, prevent incidents from happening or recurring in the future, and proactively facilitate predicting potential events for continuous improvement:

Reactive Features

ISO, OHS, and associated standards or regulations recommend a proactive approach to safety management, laying stress on preventing events. However, even with the best of efforts, some events are bound to blow up but need to be addressed immediately to contain the damage through appropriate corrective actions.

Therefore, businesses should invest in a software that allows incident reporting and management.

Incident Management – When an event occurs, a timely response can reduce the damage it causes. By providing employees with mobile ready incident reporting tools, safety leaders can get immediate alerts in case of an incident even in remote worksites. Workers should be able to upload images and report the event without delay so that safety leaders can provide guidance about the action that needs to be taken to stop the incident from amplifying further, making people safe, providing first-aid, contacting the appropriate agencies where necessary, etc.

Investigating Incidents – Once the corrective action has been taken, safety leaders need to investigate it thoroughly to identify the immediate and the root cause. This will help in taking preventative action so that there is no recurrence.

Documentation – This is an important part of incident management, as required by regulatory bodies. The incident, causes, action taken, and measures to prevent recurrence need to be documented and submitted. By digitalizing the process, documentation becomes easier, as also accessing the data later for audits and management reviews.

Collaboration – Collaboration between different functions and agencies becomes important during emergency situations. By providing a seamless, cloud-based communication and collaboration solution, it becomes possible to collaborate in real time and handle events in real time.

Preventive Features

Risks lurk in organizations all the time. Organizations and safety leaders have a responsibility to identify solutions to recurring hazards and identify new risks constantly. Therefore, they need features such as:

Risk Management – A risk-based approach is recommended by regulatory bodies to identify risks, prioritize them, and address them to minimize workplace injuries and illnesses. A centralized repository of all observed and potential risks can help safety leaders to proactively address them and make the workplace safer.

Training – Identifying skill gaps and providing relevant training to the employees concerned can ensure that they discharge their responsibilities ably, safely, and effectively. Automating the process can help ensure the training has been taken, the employee is assessed and ready, and schedule future training to keep them up to date.

Safety Control Tower – By having a Safety Control Tower, health and safety leaders are able to have a finger on the pulse of all key safety data and metrics. Additionally, they can track open action items, status of risk mitigation efforts planned, etc. By having a Control Tower, H&S leaders can have end-to-end visibility across the safety management lifecycle.

Proactive Features

In addition to being reactive, health & safety leaders must adopt a proactive approach to safety management. Having an EHS solution that enables the following capabilities will make life easier for the safety team:

Continuous Improvement – Safety management is a dynamic, ever evolving requirement. With regulatory changes, the evolution of the industry, and shifting safety risks, businesses need to constantly monitor and measure safety controls to ensure they are effective. They need to track the KPIs and ensure that they are performing as expected. They must leverage audit findings and documentation to identify areas for improvement and take efforts accordingly.

Reinforce Positive Behaviors– Safety is not just about finding lags. It is also important to encourage safe behavior by recognizing and appreciating correct behavior. This will encourage employees to continue to focus on safety.

Promote Awareness – Creating events around safety, such as safety day, putting up posters, standardizing safety behaviors such as dress code, wearing proper PPE, effective handling of equipment, etc., will help drive home the importance of safety.

CQ Safety Management for Life Sciences

At ComplianceQuest, we’ve helped life sciences companies in 1200+ locations around the world automate their quality, health, safety, and environment management system with our modern, next-generation QHSE solution.

Our QHSE solution is scalable, flexible, and customizable, and comes with in-built risk management capabilities. We also make sure health and safety professionals have data at their fingertips, can collaborate with ease, and track open action items to closure. It also has a world-class management review solution, to ensure seamless communication among executive leaders, the health and safety team, and the rest of the organization.

With CQ EHS, you can automate Incident, Document, Audit and Risk Management, Near-Misses and Safety Observations Analytics, Supplier Safety Management, Management Reviews, and Permit to Work.

Request a demo here: https://www.compliancequest.com/online-demo/