Performing remote audits is challenging for auditees and auditors. There is no possibility to have on site tour, no possibility to show or observe production lines and operators doing routine checks, etc. 

Before COVID-19 we already performed desk audits as one of the options for our clients: the experience was already there.

Remote audits have many limitations. As mentioned before, the main obstacle is that there is no possibility to visit the production lines and observe the production environment. 

This type of audit is therefore focusing mainly on documentation. Remote audits are in that perspective great opportunities to have a detailed audit of your Quality Management System. 

After a few months of auditing from home, I would like to share the 5 main areas for improvement found during remote audits and the specific findings:

1. Corrective Action and Preventive Action/CAPA/Improvement Actions:

• No procedure in place defining when the completion of a root cause analysis is necessary and corrective actions have to be defined, and when the determination of preventive actions is required. 

TIP: As a minimum improvement actions have to be defined for:

• Audits: internal, external, certification audits;
• Complaints: internal, external;
• Non-conformities, incidents.
   
• Preventive and corrective measures are not documented.

TIP: Documentation on root cause analysis like 5why and fish bonediagrams is also a good way to back up your improvement actions.
 

2. Management of subcontracted activities and outsourced processes 

• Lack of a process describing the approval and monitoring of outsourced productions or parts of it.
• Records are not available for subcontracted or outsourced process. E.g.:
  • Specifications are not present for outsourced or subcontracted work;
  • Traceability exercise does not include outsourced activities;
  • Lack of a list with requirements on analysis and the frequency of analysis for outsourced or traded products.
• Lack of supplier qualification for subcontracted or outsourced companies.

3. Rework

• Lack of a process describing rework

TIP: A documented system in place will help you to control the use of rework material. Critical is to prevent the "add back" of materials that may cause physical, biological, or chemical contamination.

• Rework is not fully traceable

TIP: Remember to identify the minimum information: product name, production date and original lot number(s).

TIP: Include rework in the traceability exercise.

4. Traceability documentation

• The frequency of conducting traceability tests is not clearly defined;
• The traceability test does not verify upstream (from delivered products to raw materials) and downstream traceability (from raw materials to delivered products); 
• The traceability test does not include a quantity check/mass balance;
• Test results of traceability exercise are not recorded;
• Lack of improvement actions;
• Lack of confirmation from customers about traced product – the amount of delivered finished product and the dates.

5. Product Fraud

• A product fraud vulnerability assessment is not in place or incomplete. 

TIP: The vulnerability assessment of food fraud should cover:

• Incoming goods (raw materials, additives, inks, adhesives, solvents, wrapping, materials, rework)
• Product formula
• Configuration;
• Processes (including outsourced processes); 
• Packaging and labelling;
• Storage;
• Transportation;
• Finished product
   
• Lack of clearly defined criteria for the vulnerability assessment.
• Lack of a product fraud mitigation plan.

Do you have experience with remote audits? After reading the above list, have you found 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.