Are You Audit-Ready? Mandatory ISO 22716 Prerequisites
1. Live Production & Operational Status
An ISO 22716 audit is an assessment of “Good Manufacturing Practices” (GMP).
- The Fact: The facility must be operational during the audit.
- The Requirement: Auditors must observe live production, packaging, or quality control activities to verify that your SOPs (Standard Operating Procedures) are being followed in real-time.
2. The 3-Month Data Window
A management system without data is just a set of intentions.
- The Fact: Your GMP system must have been fully operational for a minimum of 3 months prior to the audit.
- The Requirement: The auditor will require access to three months of “sampling data,” including batch records, cleaning logs, and environmental monitoring, to ensure consistency and compliance over time.
3. Internal Audit Completion
You cannot proceed to a certification audit without first auditing yourself.
- The Fact: A full suite of internal audits must be completed across all sections of the ISO 22716 standard.
- The Requirement: You must provide evidence of the internal audit report, any non-conformities identified, and the corrective actions taken to resolve them.
4. Recall Simulation (Mock Recall)
Section 14 of ISO 22716 requires a robust system for handling complaints and recalls.
- The Fact: You must have conducted at least one full recall simulation within the 12 months prior to your audit.
- The Requirement: You must present the results of this simulation, proving that your team can identify and “freeze” affected products within a specific timeframe (usually 2–4 hours).
5. The Traceability Challenge
Traceability is the backbone of ISO 22716. During the audit, a “Traceability Challenge” will be conducted on a random sample selected by the auditor.
The Goal: To prove that every single ingredient and process step is accounted for and documented.
The Process: Starting from a finished product batch, you must be able to trace backwards to:
The specific raw materials used (including supplier batch numbers).
The packaging components.
The operators involved in production.
The cleaning records for the equipment used for that specific batch.
