This document presents a Risk Assessment for Employees Not Following Hierarchy in a small pharmaceutical company.
In smaller organizations, clear reporting lines and defined responsibilities are essential to maintain control over processes, ensure compliance with regulatory requirements, and safeguard product quality. Without strict adherence to the established hierarchy, there is an increased risk of unauthorized decisions, inconsistent practices, and failures in accountability. In a small pharmaceutical company, clear organizational hierarchy is critical to ensure that processes remain controlled, compliant, and efficient. Unlike larger organizations, where multiple layers of oversight exist, smaller teams rely heavily on defined roles and direct accountability to prevent errors and maintain regulatory compliance.
Not following the established hierarchy can result in unauthorized decisions, inconsistent practices, and potential quality or compliance failures. This risk assessment aims to identify the risks associated with bypassing reporting lines and to recommend practical controls suitable for a small-scale pharmaceutical environment.
Hazard Description:
Employees bypass the established chain of command or do not follow the escalation and approval process.
Potential Consequences:
- Miscommunication and conflicting instructions
- Delays in decision-making
- Non-compliance with SOPs and regulatory requirements
- Undermining of management authority and accountability
- Errors due to lack of proper authorization
- Low team morale and frustration
Existing Controls
- Organizational structure and hierarchy charts displayed
- Standard Operating Procedures outlining reporting lines
- Clear job descriptions
- Regular training on communication protocols
- Supervisors monitoring adherence
- Disciplinary policy for repeated non-compliance
Risk Evaluation
| Hazard | Likelihood | Severity | Risk Rating |
|---|---|---|---|
| Miscommunication causing process errors | Possible | Moderate | Medium |
| Non-compliance with SOPs | Likely | Major | High |
| Delays in escalations | Possible | Moderate | Medium |
| Team conflict and morale issues | Likely | Moderate | High |
Additional Controls Required
- Conduct refresher training emphasizing the importance of hierarchy and escalation paths
- Reinforce expectations through team meetings
- Implement electronic workflow systems to prevent unauthorized approvals
- Periodic audits of compliance with reporting lines
- Zero-tolerance policy for critical breaches
Residual Risk After Controls
| Hazard | Likelihood | Severity | Residual Risk |
|---|---|---|---|
| Miscommunication causing errors | Unlikely | Moderate | Low |
| Non-compliance with SOPs | Possible | Major | Medium |
| Delays in escalation | Unlikely | Moderate | Low |
| Team conflict | Possible | Moderate | Medium |
Responsible Persons
- Department Managers: Enforce adherence
- HR: Training and disciplinary actions
- Supervisors: Day-to-day monitoring
- Employees: Comply with reporting lines
Review
Risk assessment for Employees not following Hierarchy should be reviewed annually or following an incident of non-compliance.
Risk-Assessment-for-Employees-not-following-Hierarchy