Supplier Qualification as a Service

Purpose of Qualification

When changing suppliers or outsourcing manufacturing, it is essential to adopt a two-way approach from the very beginning.  On the one hand, there is the Qualification of the supplier itself, and on the other hand, the Qualification of the material and the products to be purchased. It is essential to ensure that the supplier complies with all relevant regulations and standards, and consistently implements the QM standards according to the Quality Management System (QMS). Additionally, the material and product-specific requirements must be met, and contractual agreements regarding performance and changes must be considered.

When is qualification required?

Qualification is required whenever new products are manufactured, changes are made to product or machine specifications, a supplier change occurs, or production is relocated. In these cases, specification requirements such as machine parameters, transport, storage, and contamination, as well as performance indicators, must be defined. Once these criteria and expectations are met, the qualification process can begin. Remember to also consider your supplier's suppliers!

Supplier Qualification

The Supplier Qualification process comprises a series of steps that may result in one of three outcomes: the supplier is qualified, conditionally qualified (CAPA may be required) or disqualified. Firstly, the specification requirements for machinery, storage, transport, etc. must be met. This is followed by an inspection or supplier audit. If necessary, successful corrective actions are implemented. Finally, the Quality Agreement is completed and the supplier is added to the Approved Supplier List (ASL).

Material Qualification

The Performance Qualification (PQ) is conducted through a 100% inspection or a predefined sampling plan and evaluated accordingly. In order to prepare for the PQ, process documentation must be created and the product design and specifications provided. It is essential that the sampling plan for the PQ is carefully defined, ensuring that the material is clearly traceable. Additionally, qualified employees must be planned for validation. If the material meets the predefined parameters, it is considered qualified.

Supplier Audit

In some cases, the supplier audit and initial sampling can be executed simultaneously. If the supplier is already listed and only a new product requires qualification, a supplier audit may not be necessary, provided the supplier’s performance is at least acceptable. During the audit, the storage conditions are checked against material storage specifications, the manufacturing processes are evaluated for compliance with specifications and requirements, and sampling and traceability are verified. Finally, the results of the product analysis and audit are evaluated.

Supplier Onboarding

We strongly recommend implementing a Supplier Onboarding Process. In addition to the criteria to be fulfilled according to qualification, this also includes monitoring and evaluation activities, which should be agreed upon in a contract. The first step is to define the general requirements for suppliers, along with the contact person and escalation level. Establish monitoring, evaluation, and documentation activities, and define and incorporate Change Management activities into the Supplier Agreement. Finally, ensure that the offboarding process is also considered during onboarding.

Qualification as a Service

Sometimes companies lack personnel resources and subject matter expertise. This is where experienced service providers can help. If you have any questions, our team of experts will be happy to support you.