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

• Lack of detailed programs describing how contamination with foreign and extraneous materials is prevented.
• A register to control and record glass or brittle plastics breakage is not in place or not followed.

The foreign body risks I see most often are:

• flaking paint in the production area. There is open product, so potential contamination of product;
• rust and flaking paint present on the construction (not stainless steel) next or above open product;
• temporary repairs, e.g. scotch tape on the production line (tape and carton engineering);
• Silicone used by maintenance (as a temporary repairs) close to open product;
• the quality of welding in the production line not in good condition: welding with some gaps and damages welding. Those are not only potential sources of metal pieces coming off, but also pose a microbiological risk as bad welding is hard to clean and disinfect;
• Small threads and missing pieces on the plastic and Teflon equipment, e.g. scoops and cleaning material. Those tools have direct contact with the product.
   

2. Invalid documentation

• Lack of a detailed document control procedure. 

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.

• List of documents not in place or not updated.

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.

• It’s not clear how the operators should fill in the report.

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

• GMP's not defined and implemented for all areas. 

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.

• Very often I observe bottles with water in different places. 

TIP: Drinking water is allowed in the production area, however, there should be a defined clear area where this is allowed.

• Not clearly communicated and executed requirements for personal hygiene.

TIP: Posters or photos of basic personal hygiene rules in the production area really works well.

• Working conditions and protective clothing are not properly understood and followed.

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.

• Lack of a 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.

• Risk analysis does not include people as a potential risk from defence point of view.Plan is not reevaluated at least annually.

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

• Lack of a process describing the responsibility for blocking and releasing product.

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.

• Pallets or modules on hold are not identified and controlled.

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 info@quontinuim.com and we’ll see what we can do for you within our Call-an-Expert program.