Quality management and environmental, health, and safety (EHS) have traditionally existed as siloed processes and roles in most organizations. It’s easy to see why, given the forces that have shaped quality and safety over their history.
Modern quality management was born from the post-WWII era of increased competition during a rapidly growing global economy. Alternatively, EHS management grew out of the labor movement and high-profile environmental disasters over the past several decades.
However, recent years have seen a shift away from siloed management of these functions. Today, many manufacturers have started integrating EHS and quality, most commonly by placing them under a combined leadership role.
So what’s driving the shift, and what are the potential benefits for companies that integrate EHS and quality systems?
Here we examine this approach, and how the quality management system (QMS) fits into it.
Quality and Safety: Two Sides of the Same Coin
Some experts consider safety a part of quality. However, this opinion isn’t necessarily a popular one in organizations where quality and safety are highly segmented. Regardless, there is an undeniable connection between quality and safety in manufacturing.
After all, it’s unlikely that an operator careless about safety will be vigilant about holding quality standards in place. Similarly, someone who disregards quality protocols is also likely to ignore safety procedures.
In a larger sense, quality and safety are both fundamental, interrelated drivers of operational excellence. People who feel safe at work create better, higher quality products. Furthermore, a true commitment to quality goes beyond whether or not products meet customer expectations. It also means prioritizing quality of work life and managing the broader social and environmental impacts of your operations.
The ISO Perspective for EHS and Quality
Some companies seek to integrate quality and safety because of their central connection to operational excellence. A more practical reason, however, relates to ISO certification. While ISO 9001 doesn’t explicitly mention safety, it does require compliance with all applicable regulatory requirements, which include EHS regulations.
As a result, customer audits and ISO certification audits often involve an examination of safety systems. For example, auditors may ask about your process for managing safety incidents, or where you keep your OSHA Form 300 log.
From this perspective, it’s understandable that companies sometimes put EHS and quality systems under the responsibility of the quality manager. That said, this approach may not be suitable where extensive expertise of both quality and safety is not present within the current organizational structure. However, the speed of change and compliance requirements necessitate change. EHS within the quality system creates a master system that meets compliance standards by providing a powerful means to proactively monitor and control risk.
A Flexible Approach to Integration of EHS and Quality Systems
In the past, companies typically managed quality and safety using separate enterprise software systems or a patchwork of point solutions. This approach creates inconsistency, redundancy, and inefficiency. In addition, it obscures visibility into an organization’s compliance status as a whole.
Recognizing the connection between quality and safety, many companies today are instead adopting integrated Environment, Health, Safety, and Quality (EHSQ) platforms. This approach helps effectively harmonize quality and EHS, while still giving each department flexibility and control over their processes.
Streamlining ISO certification and customer audits by making documents quickly accessible from a single system (including ISO 9001, ISO 14001, and ISO 45001)
Enhancing visibility through plant-level and corporate-level compliance reporting
Improving efficiency and process alignment by using the same tools for processes common to quality and safety
Reducing overhead and IT footprint by eliminating redundancies between software solutions
Mitigating risk through more robust data tracking and trending as well as closed-loop issue management
Ultimately, an EHSQ platform enables a level of integration that promotes operational excellence and enhances collaboration between quality and safety.
What to Look for in an EHSQSolution
When considering the right EHSQ platform for your organization, it’s critical to ensure it has the right features and functions. On a basic level, the software must include solutions for processes common to both quality and safety, including:
Document management: An integrated EHSQ platform helps centralize documents essential to quality and safety. These include safety policies, standard operating procedures (SOPs), work instructions with quality and safety protocols, and more. Compared with shared servers or paper documents, an EHSQ platform helps keep documentation up-to-date and link changes to related processes such as employee training.
Employee training tracking: External auditors will likely ask to review employee training records, so having them in one place can expedite the process. An integrated platform also helps ensure people are trained on process changes.
Audit management: Manufacturers often incorporate safety items into internal audit checklists, which must be updated regularly to reflect emerging risks. An EHSQ solution and helps standardize audit processes so problems don’t fall through the cracks. Furthermore, overlap among ISO 9001, ISO 14001, and ISO 45001 requirements justifies integration of EHS in quality systems to eliminate redundancies.
Corrective action: A closed-loop corrective action solution ties together all the steps for managing quality and safety issues. It also creates a single compliance record of corrective action activities, including investigation results, action items, review, and approval.
Integration is also key, not just in terms of standardizing the above tools. You should also be able to connect all related processes within the quality system, such as change control and risk management.
Finally, companies must consider the configurability of the system. Given that departments may have spent years developing their processes, the software should allow you to create workflows aligned with your processes. If you have to change your process to fit the software’s constraints, it impacts efficiency and user adoption. Ultimately, if people don’t use the EHSQ system, your investment will be a waste.
Safety and quality processes have significant overlap and are both closely related to operational excellence and ISO compliance. Some companies acknowledge this by making safety part of the quality manager’s job, however, this is only a surface-level approach.
However, adopting an integrated EHSQ software solution provides for a more meaningful level of integration. With this strategy, companies can track quality and safety in one location, streamline processes, and gain greater visibility to drive operational excellence.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
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