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How and where companies can start implementing the six steps to have the ICH-Q9 and ICH-Q10 comprehensive management programs.

I was analyzing the standard ICH-Q9 “Quality Risk Management” to identify hazards from the GMP’s stand point of view during the process of developing, pilot and commercial production, inspection, storage, and delivery of the finished pharmaceutical product to avoid jeopardizing the safety of the patient.

The standard list some of the risk evaluation methodologies such as HAZOP, fault tree analysis, what if, that have been used in process safety to identify hazards and perform the risk assessment through frequency, severity and probability to recommend actions to detect and eliminate the potential outcomes. 

How can the pharmaceutical companies transfer these skills from one discipline to another?

The second pillar foundation of the Risk Based Process Safety (RBPS) is understanding the Hazard that has two major components:

  1.    Process Safety Information (PSI): This element compiles information about the process, such as
  •    PI&Ds,
  •    Process flow diagrams,
  •    safety parameters,
  •    SOPs,
  •    training programs,
  •    preventive maintenance programs,
  •    MSDS,
  •    Standards and regulation,
  •    incidents and near miss investigations,
  •    potential hazards trending, and resolutions implemented,
  •    mechanical integrity manual and studies,
  •    chemical reaction mechanisms,
  •    the raw material list, equipment specs,
  •    other incidents occurrences in the industry,
  •    emergency protocols and procedures,
  •    fire safety plan and,
  •    other information of the process assessed.

1.1    Process GMP Information: The information required to perform the assessment will be:

  •    PI&Ds,
  •    the process flow of the product (this includes raw material reception and approval, storage, release, production, quarantine, QC analysis, finish product released and delivery),
  •    parameters to approved release of raw material and finished product,
  •    master batch records,
  •    critical process parameters,
  •    master cleaning records,
  •    SOPs,
  •    training programs,
  •    process transfer technology documentation,
  •    GMP standard ICH-Q7,
  •    management of change (in some companies known as equipment control change),
  •    mechanical integrity,
  •    GMP incident investigations, deviations, and near misses,
  •    chemical reaction mechanisms,
  •    clinical studies and
  •    other information regards on the process or product assessed
  1.    Process Hazards Analysis (PHA): The following steps needs to occur before conducting the PHA:
  • Split the process in nodes to make the assessment manageable to define the scope of each one.
  • Confirm the team. All departments involved in the process may have a representation depending on the extent,
  • select the methodology according to the process to assess. My recommendation to evaluate a process, what if or HAZOP will be a right choice. Fault tree analysis will help to identify in what circumstances the controls and the equipment will fail,
  • populate, the PHA with specific questions depending the process to analyze, will contribute to saving time. The process engineers and the QA specialist that own the process are important to consult in this step. More items will come up during the PHA,
  • populate the process safety information section by referring all documents used in the assessment, and,
  • Conduct the PHA. Depending on the complexity of the process, it can take a week or more. Resources need to be allocated to achieve a success PHA.

3.    Process GMP Assessment.  All the steps are the same to perform this assessment. In this evaluation, the assistance on Quality Assurance is critical for GMP compliance and knowledge of other standards such as ICH-Q7, ICH-Q8, and ICH-Q10.



Here are the six steps to start implementing the Six Steps to have the ICH-Q9 and ICH-Q10 comprehensive management programs.

Step 1: Design the implementation project with goals and objectives




The Benefits are.


  • Makes a strong public statement about a company’s commitment to protecting the well-being of workers and maintaining a culture of safety on job sites. A win-win for everyone!
  • Employers who achieve and maintain COR may be eligible to receive up to 15% in annual incentive.
  • Over time, with reduced injuries and lower claim costs, a COR company’s experience-rated WSIB premiums will reflect additional savings.
  • Many general contractors require subcontractors to have a recognized safety program in place as a prequalification to bid on projects. COR meets that requirement.



Phase 3:  Establish concepts such as lean safety and introduce the OSHAS 18001




An effective health and safety management system can provide benefits to your customers and give you a competitive advantage by:


  •    Minimising the risks of production delays
  •    Providing a safe environment to do business
  •    Demonstrating your commitment to maintaining an adequate health and safety policy


Other benefits make your organization more efficient, able to meet its legal requirements and help to improve staff morale by making the workplace a safer environment to work. 


Benefits to the organization include:


  •    Improving your reputation and increase your opportunities to gain new business
  •    Minimising risks of downtime through accidents
  •    Demonstrating your commitment to meet legal obligations
  •    Possible cost savings from public liability insurance premiums
  •    Maintaining compliance with statutory requirements
  •    Providing a robust system to manage and to improve health and safety
  •    When people look at facility improvement opportunities, they often look at process improvement methodologies, such as Lean Manufacturing. Another thing that is commonly reviewed is facility safety improvements. In many cases, however, they don’t see that using lean manufacturing techniques can often also provide safety improvements.
  •    Thinking about safety lean manufacturing will allow you to make improvements throughout your facility in a way that will not only reduce waste and increase profitability but also help improve safety at the same time. The following are five examples of how lean can directly enhance safety within your facility.
  •    According to DesignSafe’s document on, Integrating Safety and Lean Manufacturing
  •    Safety must not be viewed as a separate activity that is a nonvalue-added effort with objectives contrary to lean concepts. Elimination of waste can also be interpreted as the elimination or minimization of risk that adversely affects wasted human resources and lost time from injuries. Lean imperatives of faster, better, and cheaper must encompass the issue of running safer as well.



What do you think your organization would look like if you actually did all of the three steps Do you want to find out?





If you are interested, I suggest you contact me.


Best Regards


Edgar Fernandez


Safefficient Limited.


Brantford ON, Canada