Intelilab tailors the scope to the company's activity. Manufacturing, distribution and storage require different controls and should not be assessed with the same checklist.
Before inspections, during implementation or review of the Quality System, after significant changes or when the company needs to correct problems with traceability, nonconformities, CAPA, suppliers or complaints.
Depending on the activity:
The analysis checks whether records make it possible to identify the origin, movement and destination of the product within the scope of the operation.
When useful, we select a sample to reconstruct the path of products or batches using the available records.
A product identified as nonconforming must be controlled until an appropriate disposition is defined.
When the problem points to a process failure, the company may need to investigate the cause and define actions. We assess the records, responsibilities and follow-up of these actions.
Complaints can provide important information about the product, distribution or use.
The analysis considers how the company receives, records, evaluates, routes and follows up on these occurrences within the responsibilities of the operation.
We can assess receiving, storage conditions, segregation, inventory, dispatch, returns, outsourced transportation and traceability.
The scope is tailored to the products and the conditions that need to be maintained.
A manufacturing site may require analysis of production, equipment, process, inspection and validation.
For a distributor or storage provider, the work may focus on receiving, storage conditions, traceability, suppliers, shipping, returns and complaints.
The first step is to define which processes and controls apply to the company's activity.
We review procedures and records related to the processes selected for the work. Interviews and site visits are included when the scope requires them.
The conclusion must point to the evidence used and keep what was confirmed separate from what still requires verification.
Yes. The scope is different for each activity.
Yes. The project can be limited to a specific process.
No. It uses only the answers provided and serves as an initial screening.