When Should An Authorising Engineer Be Engaged On A Project?

An AE is an independent, highly qualified professional responsible for providing oversight, governance, and technical expertise in safety-critical Life Science environments. Their primary role is to ensure that an organisation’s operational and maintenance procedures comply with relevant legislation, standards, and industry best practices.

An AE's responsibilities include:

• Advising on policies, procedures and best practice
• Conducting audits and inspections
• Overseeing competency assessments
• Providing guidance on risk management
• Ensuring compliance with health and safety regulations
• Appointing and managing Authorised Persons (APs)

Given these critical responsibilities, for a Life Science organisation, engaging an AE at the right time is vital to any project's success.

Engaging an AE during the early stages of a project ensures that regulatory and safety considerations are incorporated into the project’s foundation. During this stage, an AE can:

• Identify regulatory requirements and potential compliance challenges
• Advise on best practices and industry standards
• Provide input on risk assessments and safety planning
• Help develop operational policies that align with legislation
• Ensure User Requirements are suitably documented and approved

Early engagement reduces the potential of costly design changes later on and ensures that compliance is built into the project at the initial stages.

At the design stage of a Life Science project, an AE’s role becomes more technical and specific. The AE's primary role at the Design and Planning stage of the project is to ensure that project design aligns with safety standards, operational efficiency, guidelines, standards and recognised industry best practice. Key contributions from the AE at this stage include:

• Reviewing technical designs for compliance with safety and engineering regulations
• Ensuring that the proposed infrastructure supports safe working practices
• Advising on control measures to mitigate hazards
• Advising on industry best practice and guideline implementation
• Assisting in developing maintenance strategies that ensure long-term compliance
• Ensuring the User Requirements have been satisfied by the proposed design
• Supporting the Risk Assessment of any derogations

AE involvement during the Design and Planning stage of a Life Science project is critical because design flaws related to compliance and Patient impact can be extremely costly to rectify once construction begins.

During the construction and installation stage, the involvement of an AE provides oversight to ensure that the execution aligns with regulatory requirements, safety requirements, User requirements and the approved design. Their role includes:

• Conducting inspections and audits to verify compliance with standards
• Ensuring that contractors follow best practices for safety and operations
• Reviewing and approving commissioning procedures
• Providing training and competency assessments for personnel

Engaging an AE at this stage helps mitigate risks and ensures that all systems and processes are set up correctly from the outset.

The Commissioning, Qualification and Handover stage is where the project transitions from construction to operational use. At this point, the AE ensures that:

• All safety systems and controls are tested and operational
• Compliance documentation is complete and accurate
• Authorised Persons (APs) are appointed and trained
• Operational procedures align with the relevant legal framework
• Independent qualification has been carried out to a suitable standard

An AE's involvement here ensures that the transition from construction to operation is smooth and fully compliant with industry standards and regulatory requirements.

Regulatory compliance is non-negotiable in the Life Science industry where patient safety is paramount. Early and continuous involvement of a Zener Engineering Services Ltd AE helps Life Science organisations avoid legal penalties, improve workplace safety, and ensure adherence to national and international standards and regulatory requirements. Most of all - protect the patient from harm.

While engaging an AE may seem like an added cost to the Life Science organisation, their involvement can lead to significant cost savings by preventing expensive rework, fines, or project delays due to non-compliance. The cost of an AE far outweighs the potential cost of litigation following patient harm. 

Zener Engineering Services Ltd AEs provide expert guidance on risk assessments and mitigation strategies, helping Life Science organisations identify and address potential hazards before they become major issues.

By ensuring that systems and processes are compliant and are on the right footing from the outset, Zener Engineering Services Ltd AEs help Life Science organisations avoid disruptions and ensure smooth operations, ultimately improving efficiency and productivity.

Zener Engineering Services Ltd AEs play a crucial role in developing and maintaining competency frameworks, ensuring that a Life Science Organisation's staff are properly trained and equipped to handle their responsibilities safely and effectively.

Many Life Science organisations make the mistake of engaging an Zener Engineering Services Ltd AE too late on to a project. Allowing a supplier to mark their own homework can lead to:

• Design flaws that require costly modifications
• Delays due to regulatory non-compliance
• Increased risk of accidents and safety incidents
• Operational inefficiencies due to lack of proper procedures

To avoid these pitfalls, Life Science organisations should integrate a Zener Engineering Services Ltd AE's involvement into their project planning from the outset.