PHARMA CHEMICAL-SAFETY LIMITED
offer expertise in the incident investigation to assess the potential causal factors and roots causes to recommend corrective and preventive actions that will prevent the occurrence of the event.
- Incident flow diagram.
- Tap-root analysis.
- Causal factors and roots cause identification
- Review SOPs, training, current practices, equipment reliability,
- Management system analysis review.
- Incident Investigation Report elaboration.
Warning. The Federal Drug Administration (FDA) has given hundred and fifty “483 Warning Letters” to the pharmaceutical, cosmetic and food industries in December 2016. Could you be one of them?
The main finding of these 150 citations had been lack of root cause analysis. The FDA requires to conduct a very detailed investigation of non- conformances to generate corrective and preventive actions, well know as CAPAs.
Do you know that the Minister of Labor of the Province of Ontario, Canada (MoL) has fined several industries about CAD 6,600,000 only in one month?
On the other hand, the MoL publishes companies that have been fined by them to inform the industries. The reason of the fines can vary. However, there is one thing in common, the outcomes have been serious injuries.
Here is how you can avoid being fined or having a 483 Warning Letter or prevent fines due to a severe injury.
We help to conduct investigations of workplace incidents and non- conformances
We guarantee you that following this methodology you will avoid forms 483 and you will be able to predict possible workplace safety incidents in the future.
Our methodology includes:
We will help you develop the incident flowchart that will show the series of event that occurred to have the incident or non- conformance.
We will help to find the causal factor or causes that may contribute to the event.
We analyze the causal factor from the operations, human factors, and management system point of view.
These previous steps will help us to prescribe corrective and preventive actions to be in compliance with the FDA or to prevent recurrence of workplace incidents that will impact your health and safety program.
Once the causal factors are identified, we proceed to identify the root causes that contributed to having a non-conformance, near miss or incident.