Quality System Work Instruction - Free Download
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Quality System Work Instruction
10-10-0901: QCS – Nonconformance Process
rev-14a00 - Approved by: QMR
WI 10-10-0901_14a00 UNCONTROLLED IF PRINTED page 1 of 4
1.0 Purpose and Scope
The purpose of this work instruction is to define the initiation, review and disposition suspect
nonconformances in product, equipment assets and associated work instructions.
This work instruction is applicable to the Material Review Board, and departments involved in the
business operations which can identify possible nonconforming products ( e.g. Shipping and
Receiving Inspection, Final Lot Inspection, Storage inspection, Customer Support, ..)
C&P Actions – Corrective and Preventive Action Cases
MRB – Material Review Board
QCS – Quality Compliance System: Online system to manage & report quality compliance
Assets: Equipment assets supporting manufacturing, inspection, storage and transport of products
Product: Raw Material, in-process products, end-products
Accept: Accept as-is, analysis has determined no nonconformance.
Rework: A nonconformance disposition whereby a nonconforming product or asset is made to conform
to a prior specified requirement by completion, reprocessing, or other corrective means. If the
nonconformance is a written document, then the document is revised.
Reclassify: Reclassify product or asset for another application.
(not applicable to written documents)
Scrap: Product or asset cannot be reworked, and must be isolated & scrapped. In the case of a written
document, the document is obsoleted.
Nonconforming products can include out of specification raw materials, in-process products and
end-products. If a nonconforming product is suspected, the company’s Material Review Board
(MRB), analyzes the details and dispositions product as: Accept, Rework, Reclassify or Scrap.
For products determined to be nonconforming, product is isolated and rework or scrap actions
Nonconforming equipment can include out of specification laboratory equipment, portable
inspection devices, shop-scales, or meters which may have an expired calibration date, provide
inconsistent results, or possibly been damaged. If a nonconformance is suspected, the
company’s Material Review Board (MRB), analyzes the details and dispositions equipment as:
Accept, Rework, Reclassify or Scrap. For equipment determined to be nonconforming, isolate the
equipment and initiate rework or scrap.
Nonconforming work instructions supporting products handling, product production and equipment
usage can be reworked to represent actual process or obsoleted (scrap) if no longer required.
A confirmed nonconformance may result in one or more corrective actions.
The company Material Review Board is chaired by Quality and has permanent members from key
functional areas, such as R&D and Operations. Temporary MRB members can be assigned when
additional knowledge of problem and/or resolution is required. Temporary MRB members typically
include, receiving for raw materials, operations personnel for in-process material, and customer
support for customer suspected non conformance.