Intelilab analyzes the controls used from receiving to shipping, including storage, environmental monitoring, traceability, returns, third parties, and operational records.
Some problems are visible in the records: out-of-range temperature, product without adequate segregation, inventory discrepancies, returns without evaluation, or suppliers with expired documentation.
Others only appear when we compare the procedure with what was carried out.
That is why the analysis needs to follow the flow of the operation and the evidence left at each step.
The scope may include:
At receiving, we check how the company verifies product, quantity, integrity, transport conditions, and the documentation required by the process.
At shipping, we look at picking, verification, product condition, documentation, and the handover of responsibility to transportation.
The analysis considers physical organization, status identification, segregation, storage conditions, access, cleaning, pest control, and other controls established for the site.
When there are products with specific requirements, the scope is adjusted to the applicable conditions.
Temperature and humidity need to be monitored when they are part of the operation's storage conditions.
The analysis may include monitoring equipment, records, alarms, handling of excursions, and thermal qualification studies when required for the environment.
Returned, damaged, suspect, or expired products, and products subject to recall, must remain identified and controlled until the appropriate decision is made.
We evaluate the records used to demonstrate this movement and the responsibilities involved.
Records must allow the product's path to be reconstructed.
In an analysis, we can test this capability using real lots or movements, within the sample defined for the work.
Hiring a third party does not remove the need to define requirements and monitor the service.
The work may review qualification criteria, documentation, contracts, incidents, and re-evaluations of critical suppliers.
When product passes through hubs, transfer points, or temporary areas, these steps need to be part of the process design.
The analysis considers dwell time, site conditions, records, responsibilities, and continuity of controls during the transfer.
We follow the physical flow of the product: receiving, storage, movement, picking, shipping and, when applicable, returns or recall.
Documents and records are analyzed together with the interviews and observations included in the scope.
Records of temperature, inventory, receiving, shipping, supplier qualification, returns, and incidents help show how controls were carried out.
A well-chosen sample is usually more useful than a stack of documents unrelated to the problem being assessed.
Depending on the service engaged:
Work can begin before an inspection, during a Quality System review, when a new warehouse is being set up, after process changes, or when recurring problems need to be investigated.
Yes, when the scope involves activities compatible with the services Intelilab provides.
Yes. The scope can be limited to a specific area or process.
The strategy and documentation can be part of the work. When execution requires specialized equipment or a specialized provider, that part is defined with the responsible partner.