Nowadays doing audit onsite is usually not accepted by the facilities, due to COVID-19, and we have to remote audits. Nevertheless, I would like to come back to my previous on-site audits and indicate the areas where most common non-conformities are found.
1. Foreign bodies found during plant tour
The foreign body risks I see most often are:
2. Invalid documentation
TIP: Define clear rules for updating the documentation: frequency, department/responsible person;
TIP: Remember to involve other departments for updating the documentation. Not all documentation should be maintained by the Quality Department.
TIP: Include documentation checks into internal audits or as a separate internal audit.
TIP: No matter where the list of documentation is maintained, in an Excel file or within a special electronic system, this needs to be verified frequently.
TIP: Prepare a short example or template à checks should be ticked, comment OK or signed (initials), as a confirmation that the check is completed.
TIP: Do not leave empty cells into a completed report. Those checks which should not be completed, cross them out or comment N/A (not applicable).
3. GMPs not followed
TIP: GMP’s should be valid for: handling, storage, packaging and delivering area
NOTE: Remember to define controlled conditions to maintain product safety and quality, if applicable.
TIP: Drinking water is allowed in the production area, however, there should be a defined clear area where this is allowed.
TIP: Posters or photos of basic personal hygiene rules in the production area really works well.
TIP: Visualization of protective clothing at the entrance into the production area is much more effective than an instruction.
TIP: Put a mirror before entering the GMP area. In this way, people can check if they comply with the GMP requirements.
TIP: All those requirements are valid for personnel, but also for contractors and visitors.
4. Product defence and plant security plan.
TIP: This plan should be prepared based on risks and vulnerabilities.
TIP: All actions based on the calculated risk, need to be documented. Description of control measures taken, and their status should be in place as well.
TIP: Revision should be performed when internal or external events, and if any relevant regulatory changes occur, but at least annually.
5. Product blocking and releasing
TIP: This process should cover blocking or releasing incoming goods, semi-finished product, rework and finished product.
TIP: The process should cover all type of activity. This is not only the production in a manufacturing site, but we have to remember about traded or outsourced activities as well.
TIP: Blocked pallets need to be identified physically and/or electronically.
TIP: Good practice is to have different status in the warehouse management system: on quarantine, on hold, under investigation or available.
After reading above the list, I hope you have the feeling that described processes work well at your site. Any point which could be improved? Send an e-mail to firstname.lastname@example.org and we’ll see what we can do for you within our Call-an-Expert program.