Safety & Risk Management

Safety and Risk Management

Safety and Risk Management

“Safety and risk management” is an overarching term that covers the safety of manufacturing processes, safety within a manufacturing facility and job site, and managing risks to ensure hazards are minimised. Effective safety and risk management protocols help to reduce workplace hazards, process failures and operational downtime.

There are a number of methodologies and tools that are used in the pharmaceutical and food processing industries to identify, analyse and manage risk. These include:

MH Chemtech believe that safety and risk management are key guiding principles of manufacturing operations, and are experienced in each of these methodologies. If you require support on safety and managing risks at your manufacturing site, please get in touch.

Hazard Identification

Hazard Identification (HAZID) is a general risk assessment tool used to identify hazards in the workplace and to formulate solutions to mitigate risks. Workplace hazards can result in lost time and productivity from injuries, resulting in financial losses. A worst case scenario would be the death of an employee, which would result in significant operational downtime and company expense.

HAZID is usually performed during project development. Projects could include process design, construction, installation, commissioning, testing, changes to existing processes and decommissioning. It therefore helps to reduce hazards once a project phase has been completed, allowing subsequent stages of the project to be performed with reduced risk.

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Hazard Analysis

Hazard Analysis (HAZAN) is a systematic method for identifying and assessing hazards in the workplace. It focuses on job tasks carried out by employees, and covers the employee, the task to be carried out, the equipment and tools used to carry out the task and the general work area.

A HAZAN study is carried out by a team comprising operators, maintenance engineers and safety personnel. It involves operators being observed performing their routine tasks and identifying potential hazards, the consequences of a hazard occurring, how the hazard could occur and the likelihood of occurrence. Control measures are then developed to reduce the chance of the hazard occurring. Control measures could include further operator training, improved personal protective equipment for the operators, or changing equipment for improved safety.

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Hazard Analysis and Critical Control Point Principles

Hazard Analysis and Critical Control Point (HACCP) principles were developed for the food processing industry to ensure food safety for consumers. It is a systematic preventative approach used to identify, control and eliminate potential food safety hazards.

The seven principles of HACCP include:

  1. Conduct a hazard analysis. This should cover biological hazards (e.g. bacteria, yeasts, molds and parasites), physical hazards (e.g. metal, glass and plastic contamination) and chemical hazards (e.g. heavy metals, pesticides, equipment lubricant and allergens).
  2. Determine the critical control points (CCPs). CCPs are determined by identifying methods to minimise critical hazards determined in step 1. Examples of CCPs include temperature control, pH control, and salt level.
  3. Establish the critical limits. After the CCPs have been determined, limits on CCP parameters are set. These can include maximum, minimum or a range, depending on the hazard.
  4. Establish monitoring procedures. Monitoring of CCPs is required to verify that they are under control. Monitoring is performed by testing for the different types of hazards through continuous monitoring (e.g. temperature, pH) or through periodic sampling and testing (e.g. bacteria, pesticides).
  5. Establish corrective actions. If CCPs fall outside their limits, known as a deviation, corrective actions are established to handle the deviation. This includes determining the cause of the deviation, the disposition of the product and what adjustments sre required to prevent recurrence of the deviation.
  6. Establish verification procedures. Procedures are established to verify that the controls are working as intended, and that the HACCP system is working effectively.
  7. Establish record keeping and documentation procedures. Documentation such as batch records, HACCP plans, verification procedures, monitoring records are required to verify that the HACCP system in under control and to satisfy regulatory requirements.

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Hazard and Operability Studies

A Hazard and Operability (HAZOP) study is a systematic method used to identify and control process hazards at the level of individual process operations. It is carried out by a team of subject matter experts usually comprising process engineers, line and equipment operators, maintenance personnel, safety managers and other personnel familiar with the process and equipment.

The HAZOP study involves identification of potential hazards for each step of a process by breaking down process designs into their individual sections, called nodes. The nodes are reviewed individually and often in sequence. In the context of the pharmaceutical and food processing industries, the HAZOP study can include a process risk assessment that also assesses patient or end user safety.

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Material Flow Analysis

Material Flow Analysis is a tool used to identify potential inefficiencies in material transfer and movement of employees while carrying out their routine job tasks. It uses a combination of LEAN and safety principles.

The primary aims of material flow analysis are to:

  • minimise excessive and inefficient transfer of materials throughout the process that can result in increased energy consumption and reduced manufacturing throughput, and
  • to minimise unnecessary movement of personnel that can reduce productivity.

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