Introduction:
The Acceptable Quality Level (AQL) inspection is a critical component of the quality assurance process that determines whether a batch of product meets predefined acceptance criteria before release or further processing. Failure to perform AQL inspection can result in the distribution of non-conforming products, leading to potential regulatory non-compliance, customer complaints, product recalls, and reputational damage.
This risk assessment aims to systematically evaluate the potential risks associated with the omission of AQL sampling and testing. By identifying contributing factors, assessing the severity, likelihood, and detectability of potential failures, and establishing appropriate control measures, this assessment ensures that the integrity, safety, and quality of the product are maintained in alignment with Good Manufacturing Practices (GMP) and regulatory expectations.
Hazard Analysis for AQL Not Performed
| Hazard | Potential Consequence | Severity | Likelihood | Detectability | Remarks |
|---|---|---|---|---|---|
| Release of non-conforming products | Defective products reaching customers, recalls, patient safety risk | Critical | Medium | Low | Major GMP and regulatory impact |
| Regulatory non-compliance | Observation during inspection, warning letters, import alerts | Major | Medium | Medium | May affect product licenses |
| Loss of product traceability | Inability to demonstrate sampling compliance | Major | Medium | Low | Weak batch records |
| Customer complaints and dissatisfaction | Damage to reputation, loss of market confidence | Major | High | Low | Complaints escalate if defects not detected |
| Increased rework and waste | Cost impact, delays in release, material wastage | Moderate | High | High | Additional labor and resource consumption |
| Undetected process variability | Process drifts remain uncorrected, systemic quality failures | Major | Medium | Low | Undermines continuous improvement efforts |
Key Notes:
- Severity: How significant the impact is if the hazard occurs.
- Likelihood: Probability that the hazard will occur due to AQL not being performed.
- Detectability: How easily the hazard can be identified before product release.
