Advanced traceability at Elitepharm: A case study

How Elitepharm’s advanced traceability system quickly resolved a quality concern: A case study

In the food supplement industry, quality and safety of products are essential. At Elitepharm Laboratoires, advanced traceability plays a key role in ensuring that these norms are thoroughly applied. We have chosen to present a case study in which our traceability system enabled a quality issue to be resolved quickly, minimizing the impact on consumers and demonstrating the effectiveness of our approach.

Advanced traceability following a foreign body suspicion

Elitepharm Laboratoires guarantees the traceability of its products, both before and after manufacturing, in compliance with the European regulation CE 178/2002. It is therefore possible to trace each batch, from the raw material to its supply, to the delivery of the finished product in which it has been incorporated.

Our quality department carries out a visual inspection of each batch received to ensure the conformity of the raw material, paying particular attention to the smell, color, texture, and absence of foreign bodies.

On June 7, 2024, during the inspection of the raw material of coconut powder, an external nonconformity was recorded due to the suspicion of foreign bodies inside the material. In such a case, the identification of the problem is formalized by the nonconformity category and the anomaly found. In this specific case, it was:

• An external nonconformity: suspicion of foreign bodies, brownish to yellow particles inside the coconut powder
• The anomaly was identified by the quality department during its organoleptic control.

Advanced traceability: the process

The initial investigation in three stages

• The first step is to review the specifications on the certificate of analysis. The certificate of analysis is unique to each batch and acts as an inventory of all the analyses and checks that have been carried out, in this case comparing the particles observed with the color range specified on the certificate. For this coconut powder, it said “beige to light brown”.
• The second step is historical analysis. It consists of reviewing previous batches received from the same supplier and analyzing the nonconformity table to detect similar cases.
• Finally, all observations, images, and a sample of the suspicious particles are sent back to the supplier for further analysis and clarification.

Corrective actions

• To avoid any risk to consumers, the advanced traceability process includes the blocking of the raw material in question as soon as the non-conformity is identified, and before it is used in production.
• Until the supplier confirms compliance, the material shall not be used.

Communication

Communication is essential for advanced traceability. Full documentation of the incident is stored within the quality system. It includes:

• Observations
• Actions undertaken
• Communication with the supplier

In this specific case, the supplier confirmed the conformity of the raw material. The brownish to yellow particles were pieces of coconut skin and are therefore inherent to the material. Their color, slightly darker, is due to the natural variability of the raw material and does not cause any safety or conformity issue.

Results and impacts of this case study

The ability to be reactive is key in the quality management process. As soon as the suspicion was identified, the raw material was blocked and quarantined to ensure the integrity of the manufacturing process.

The nonconformity was identified, analyzed and resolved in just 4 days, thanks to the reactivity of our quality department, which quickly contacted our supplier. The quality of the products, the reputation of our clients and the safety of consumers were all maintained.

An optimized approach to continuous improvement

The application of this advanced traceability process is part of Elitepharm’s continuous improvement approach. This includes reinforcing organoleptic controls to continue preventing potential risks and anomalies upstream of production. Another aspect of this approach is the optimization of communication with suppliers to clarify specifications and anticipate potential discrepancies.

This case study illustrates how advanced traceability at Elitepharm Laboratoires not only guarantees product quality and safety, but also enables us to react quickly and effectively to potential problems. Our commitment to quality is reflected in concrete actions that protect consumers and reinforce trust in our products.