Quality System Procedure - Contract Review

Most recently edited by: Paul VanderWeele
Most recent edit date: Jan 21, 2021
Edits were authorized by: Paul VanderWeele

Purpose

To review requests, tenders, or contracts.

This procedure ensures that: the customer’s requirements including the methods to be used are adequately defined, documented, and understood the laboratory has the capability and resources to meet the requirements * the appropriate test method is selected and capable of meeting the customer’s requirements

This procedure also describes the activities that take place should there be subsequent amendment to a customer’s order.

Scope / Field of Application

This procedure is to be performed by all employees who supply quotations to customers for laboratory services.

Definitions and Acronyms

Contract Review – systematic activities carried out by the supplier, before signing the contract to ensure that requirements for quality are adequately defined, free of ambiguity, documented, and can be realized.

Requirements for Quality – expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination.

Responsibilities

All employees involved in contract review are to follow this procedure.

Materials Required
Customer information
Price list
Formal service quotations

Procedure

Preparation and Review

Upon customer inquiry, the following information needs to be obtained:

A. Customer Contact person: Tel: / Fax: Address:

B. Objective / goals / required information Requested analysis: - Qualitative / semi-quantitative, limit of detection: - Quantitative, range of concentration:

C. Costs Expected costs: Cost limits:

D. Date of completion / schedule Date of intermediate results / reports: Deadline for final results / report:

E. Sampling - customer - laboratory - other Date of sampling: Source / producer: Responsible person: Number of samples:

F. Description of sample(s) Identification: Approximate composition: Main component: Minor constituent: Intended use: Packaging / stability: Special care for storage / transport / stabilization: Pretreatment / preconditioning: Reference materials / reference samples:

G. Methodology Description of methods used for sampling, sample preparation, measurement Standard method: Generic method: New / adapted method: Validation required for method:

This information is reviewed to determine the laboratory’s ability to perform the work requested by the customer. If the laboratory has the technical capabilities and resources, continue this procedure. Otherwise inform the customer that the laboratory is unable to fulfill their request.
Quotations for routine requests can be quickly provided through the standard price list.
Quotations for non-routine requests take more time to cost out and are formally issued as a service quotation document. This is typically faxed to the customer. Each new service quotation is assigned a unique number.

Acceptance of a Contract

The customer sends back the service quotation with their signature within the acceptance period and/or a purchase order referring to the service quotation.
When a customer submits samples without written authorization and the submission form requests the previously discussed services, a confirmation fax is sent to the customer informing them that the work will be performed as proposed.
When a customer submits samples without written authorization and the submission form requests services that are different from the original service quotation, the customer is contacted to clarify the required testing and to obtain written authorization to proceed.
When a customer submits samples without any prior discussion (re: required testing and pricing), the customer is contacted, requirements are reviewed, and a service quotation is issued to clarify the request and provide pricing.

Contract Amendment

Amendments to a contract are reviewed in the same manner as previously outlined.