Quality System Procedure - Purchasing and Receipt

Most recently edited by: Paul VanderWeele
Most recent edit date: Jan 13, 2021
Edits were authorized by: Paul VanderWeele

Purpose

This procedure defines the process for the selection and purchase of services and supplies. This procedure is also used for reception and storage of supplies.

Scope / Field of Application

This procedure applies to all purchases/acquisitions of services and supplies made by the laboratory.

Definitions and Acronyms

Purchase Order – Document initiating a procurement of equipment, supplies, or services.

Qualification Process – Process of demonstrating whether an entity is capable of fulfilling specified requirements.

Grade – Category or rank given to entity having the same functional use but different requirements for quality.

Responsibilities

The responsibilities of individuals who will perform the process described in this procedure are detailed in the following Procedure section.

Materials Required

Purchase Order form

Procedure

  1. The information on the Purchase Order instructs suppliers to identify packaging supplies and packing slips with the following information, as applicable:
  2. name of material
  3. vendor’s name and address
  4. lot number
  5. quantity
  6. material specification number and date

  7. certification documentation

  8. Copies of Purchase Orders of test materials and reagents are forwarded to the CFO, where they are reviewed to ensure that the latest requirements are correct.

  9. The Purchase Order record, receiving documents, and any certifications are used as control over the material being received.

  10. The CFO, Technical Manager, or Deputy Technical Managers are responsible for checking shipments of materials received for the correct quantities, for certification, if required, and to match the packing slip against the Purchase Order.

  11. Materials may be subjected to incoming inspection procedures to determine if they meet specifications. If a discrepancy is found that could affect the quality of laboratory output, the material is replaced and a disposition record is kept. If the material is accepted, the material is logged in and stored with the following information:

  12. identification of the material
  13. vendor
  14. date

  15. request for purchase number

  16. The container is labeled with the date of receipt and the shelf-life expiration date. No reagents, chemicals, standard solutions, or other time-sensitive materials should be used after the expiration of the assigned shelf-life date.

Note – If no shelf-life expiration date is available, the laboratory assigns an expiration date (e.g., 5 years).

  1. The Quality Manager periodically requires checks on the validity of a grade or certification of a purchased material. The check can be performed by the laboratory’s own capabilities or through a subcontractor. If materials do not meet their specified grade or certification, the vendor is notified and the material is replaced.

  2. The Technical Manager or his/her deputies monitor the inventory at least once a month to identify material approaching the expiration date.

  3. As supplies are used, the inventory records are updated to prevent running out of stock.

  4. Disposition records are reviewed for trends in vendor performance and to ensure high quality materials and supplies are accepted.

  5. The user of an in stock material or supply checks to ensure the material is properly identified and has a current shelf-life expiration date. When more than one container of a material is in stock, the oldest is used first.

  6. When the quality of media, reagents, chemicals, solutions or solvents are checked against standards as part of the test method they are used in, they are not checked prior to placing them in storage, other than to validate the identity, shelf-life, or certification, as covered in the steps above.

Documentation

Records for purchasing include:

Required Record Purchase Orders Performance data of contractor performance Material and supply inventory Packing slips

Reference Procedures

Test methods specifying the requirements or grade of supplies.