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Quality Management System Procedure: (Laboratory Name)

This document outlines a laboratory's procedure for purchasing supplies and services. It defines responsibilities for the purchasing process, including reviewing requests, checking shipments, performing inspections, and maintaining inventory records. The procedure aims to ensure the correct materials are received and stored properly with appropriate documentation.

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jeric bañadera
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56 views3 pages

Quality Management System Procedure: (Laboratory Name)

This document outlines a laboratory's procedure for purchasing supplies and services. It defines responsibilities for the purchasing process, including reviewing requests, checking shipments, performing inspections, and maintaining inventory records. The procedure aims to ensure the correct materials are received and stored properly with appropriate documentation.

Uploaded by

jeric bañadera
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 3

Quality Management System Procedure Issue Date: Rev.

[Laboratory Name] YYYY/MM/DD 0


Page #:
QSP 4-6-1 - Purchasing
1 of 3

Prepared by: Date:

Reviewed by: Date:

Approved by: Date:

The colored ink stamp indicates this is a controlled document. Absence of color indicates this copy
is not controlled and will not receive revision updates.

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


Request for Purchase – 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
Request for Purchase form

Effective Date: YYYY/MM/DD


Quality Management System Procedure Issue Date: Rev.:

[Laboratory Name] YYYY/MM/DD 0


Page #:
QSP 4-6-1 - Purchasing
2 of 3

Procedure

1. The information on the Request for Purchase instructs suppliers to identify packaging supplies
and packing slips with the following information, as applicable:
 name of material
 vendor’s name and address
 lot number
 quantity
 material specification number and date
 certification documentation

2. Copies of Requests for Purchase of test materials and reagents are forwarded to the Purchasing
Department, where they are reviewed to ensure that the latest requirements are correct.

3. The Requests for Purchase record, receiving documents, and any certifications are used as
control over the material being received.

4. The Facility Clerk is responsible for checking shipments of materials received for the correct
quantities, for certification, if required, and to match the packing slip against the Request for
Purchase.

5. 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:
 identification of the material
 vendor
 date
 request for purchase number

6. 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).

7. 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.

8. The Facility Clerk monitors the inventory at least once a month to identify material approaching
the expiration date.
Effective Date: YYYY/MM/DD
Quality Management System Procedure Issue Date: Rev.:

[Laboratory Name] YYYY/MM/DD 0


Page #:
QSP 4-6-1 - Purchasing
3 of 3

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

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

11. 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.

12. 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 Custodian


Request for Purchase Purchasing Department
Performance data of contractor Purchasing Department
performance
Material and supply inventory Facility Clerk
Packing slips Facility Clerk

Reference Procedures
Test methods specifying the requirements or grade of supplies.

References
Garfield, F.M., Kleska, E., Hirsch, J. 2000. Quality Assurance Principles for Analytical
Laboratories. 3rd Edition. AOAC. Gaithersburg, MD.

Revision History
Revision 0

Effective Date: YYYY/MM/DD

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