Principles for Certification Programs

 All programs are organized around key components. These components form the framework for the design, implementation and verification of every Eurofins Eurofins GeneScan program. These components can be broken into two general categories: those that relate to the Client’s organization and those that relate to the physical measures implemented by the Client. Organizational measures  are those that pertain to  the management, control and certification of the program.  Physical measures are those procedures that are directed to the  product and to the production process.

Organizational Measures:

1) Risk Assessment

A determination of those points in the supply chain where the identity or value could be compromised.

2) Specification of goal and scope of the control program

A clear statement concerning the aim and scope of the control program.

3) Commitment and Responsibilities

A list of all personnel involved with the program and their specific areas of responsibility.  Additionally, all suppliers of relevant products and services will be listed and, in order to remain as a vendor, will have to agree in writing to certain specifications relevant to their product or service.

4) Documentation

(1) Handbook

A handbook will be developed that describes  the required measures as defined by the Individual Standard. The handbook, applicable to all sites, will serve as basis for implementation and maintenance of the program and as the benchmark for external audits. It can be integrated into an existing quality management handbook.

(2) Management of documents, forms and records

The documents and records shall be managed in such a manner to ensure that up-to-date instructions and information are always available at all locations.  Procedures to control (e.g. to approve, to alter, to distribute, to archive) all documents and forms that relate to the requirements of the program will be required.

5) Training

All personnel with responsibilities related to the program shall be trained to ensure they have the appropriate skills and knowledge to perform their tasks according to the requirements stated in the handbook.

6) Control

The handbook will require that the Client   establish, and document, appropriate measures  to ensure and to verify continuous control of each identified risk so that the stated goals of the program can be achieved. If  suitable quality management or assurance systems do not exist, independent inspection activities may be established at critical points.

7) Adverse Event Management

(1) Non-Conformities and corrective actions

The handbook will define measures to identify and correct Non-Conformities.

(2) Recall actions

A recall action plan shall be specified in case products exceeding the specifications stated in the handbook have been released.

(3) Worst case plan

A worst case plan shall be specified that defines strategies to be implemented in case the supply/production of the controlled supply chain is significantly reduced by circumstances such as disaster, major contamination, etc.

8) Verification of specifications of external suppliers

Products of suppliers that are not part of the controlled supply chain shall only be accepted into the controlled supply chain if their product specifications meet the principles of the four physical measures (segregation, traceability, representative sampling and analysis) according to the program’s scope and goal.

Physical Measures:

9) Segregation

Throughout the supply chain affected by the control program, measures shall be implemented to prevent any mixing of the controlled product with uncontrolled material.

At least one “Hold and Release” point shall be defined within the supply chain, preferably at entry point.

10)    Traceability

At any point within the supply chain a documentation system shall be in place that allows timely identification of the origin, quantity and quality of the controlled material.

A clear relation shall be established between lots/batches and correlating analytical results.

11)    Sampling

A sampling plan shall be defined to allow representative verification of  the ingredients and final products in the supply chain,  taking into consideration:

· Sampling at strategic points according to an internationally accepted sampling procedure

· Size of sample for analysis based on statistical considerations

· Maximum lot size

· Quality assurance of sampling

 12)    Analysis

Analytical methods shall be applied that are appropriate to identify and quantify the quality of the ingredients or final products. The specific tests chosen shall be appropriate for the material being testing with regard to criteria such  as third-party recognition of the methods used and regulatory factors. Eurofins Eurofins GeneScan will be the final arbiter regarding suitability of a test method, or a testing laboratory, for inclusion in any program certified by Eurofins GeneScan.

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