Identifier: CX-CP-2.
01
Document Type: Corporate Procedure
Revision: 18
Title: Quality Assurance Approval of Raw Materials
PURPOSE
Quality Assurance is responsible for reviewing all raw material receipts and approving their use in
production. The approval process must assure the quality and identity of the material received.
Materials obtained from external suppliers must have a Certificates of Analysis (COA) or
Certificates of Compliance (COC) for each receipt. If the material is obtained from another
ChampionX facility, then the request for a COA/COC is left to the discretion of the receiving
ChampionX facility.
SCOPE
This procedure applies to all raw materials used in the production of ChampionX Chemical
Technologies products.
RELATED DOCUMENTS
CX-CP-2.10 Quality Assurance Data Documentation and Evaluation
CX-CP-2.14 Analysis Plan Authorization
CX-CP-6.01 Non-Conforming Material Handling
ACRONYMS, ABBREVIATIONS AND DEFINITIONS
Raw Material – In this procedure, refers to any in-bound materials not manufactured by
ChampionX
COA – Certificate of Analysis
COC – Certificate of Compliance
OOS – Out-Of-Specification
QCR – Quality Control Report
STO – Stock Transport Order (Internal Shipment)
ROLES AND RESPONSIBILITIES
Site Material Receiving department is responsible for delivering the received paperwork, and
samples when required per sampling plan (For example, SAP inspection plan) to Quality
Assurance for reviewing or testing.
Site Quality Assurance is responsible for performing COA/COC review or testing and make usage
decisions accordingly.
Site Quality Manager is accountable for establishing analysis plan or sampling plan and
dispositioning Out-Of-Specification (OOS) materials in accordance with site specific Non-
Conforming Material Handling procedure.
PROCEDURE
Receiving
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UNCONTROLLED COPY IF PRINTED
Identifier: CX-CP-2.01
Document Type: Corporate Procedure
Revision: 18
Title: Quality Assurance Approval of Raw Materials
Upon receiving the material, the receiving department shall deliver the receiving paperwork and
samples if required to Quality Assurance. When a sample is required, the label must include the
raw material number, ChampionX batch number, date and hazards.
Quality Inspection Status
While pending disposition from Quality Assurance, packaged raw materials shall be held in quality
inspection by physical and / or electronic means. Bulk raw materials shall not be unloaded until
approval is obtained.
Sampling Requirements
The determination of sampling requirements shall be considered based on the stability, hazards,
and material/vendor history.
Specifications
Each laboratory must ensure that the current Material Specification Report in SAP and associated
current test methods are available. A raw material cannot be accepted unless the manufacturer is
on the Approved Supplier List as cited on the current Material Specification Report in SAP.
Testing
Raw materials received from another ChampionX facility (STO) can be accepted without a
COA/COC or additional testing. If a COA/COC is necessary, then the ChampionX facility sending
the material must comply.
Quality Assurance is responsible for the approval of raw materials to ensure that the material
meets the corporate requirements for identity and quality as described in the current Approval to
Receive tests listed on the Material Specification Report in SAP. Local Quality Assurance
management may determine which raw materials and parameters may be placed on an Analysis
Plan based on application and risk at their site. This determination process is described in the next
section “Analysis Plan”.
Analysis Plan
Approval to Receive parameters, which are not deemed critical, can be placed on an analysis
plan. The proposed raw material parameter must be within specification for a period of one year
or twenty receipts. Local Quality Assurance management should use professional judgment with
safety and risk to the process in mind. The proposed parameter should:
1) Appear on the supplier’s COA or COC, or
2) Be identified via an indirect method to ensure the parameter is in-specification, or
3) Have a material/vendor history that justify an Analysis Plan per CX-CP-2.14 Analysis
Plan Authorization
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Identifier: CX-CP-2.01
Document Type: Corporate Procedure
Revision: 18
Title: Quality Assurance Approval of Raw Materials
Each laboratory maintains the documentation (electronic or hard copy) to justify the analysis plan
(s). The inspection interval is determined by Local Quality Assurance management and is based
upon the material stability, hazard, and/or material/supplier’s history. At a minimum, a yearly
inspection interval is recommended. Each existing analysis plan should be reviewed to ensure
that the frequency established is appropriate. If a parameter on an analysis plan is tested and
found to be out-of-specification, then the analysis plan is removed.
Special consideration should be given to:
1) Raw material parameters deemed critical to manufacture products within specification
2) Raw materials which are unstable or susceptible to deterioration or contamination in
transit
3) Raw materials that may subject to degradation once container is opened
Note: For those sites not on SAP, a system for tracking analysis plans must be in place. The
system must assure that the parameter is analyzed at the proposed frequency.
Data Recording
A Quality Control Report (QCR) will be generated for each raw material receipt per vendor lot
number. (A QCR is the SAP inspection worksheet. For those sites not operating in SAP, the local
system shall be used to document the inspection.) All results, whether in-specification or out-of-
specification, will be recorded on the QCR. QCR’s and Supplier’s COA/COC must be maintained
in accordance with respective site Record Retention procedure.
Data Evaluation
Quality Assurance at each ChampionX plant is responsible and accountable for the evaluation of
raw material data and shall employ good laboratory practices in their execution and
documentation. Where appropriate, statistical methods shall be used in the laboratory for the
evaluation of the quality of test data. When evaluating the test data, the guidelines for
interpretation of reanalysis and resample data should always be applied. (Refer to CX-CP-2.10
Quality Assurance Data Documentation and Evaluation) Upon completion of the data evaluation,
authorized personnel will document the approval, reanalysis, resampling, or rejection of the
material.
Approval
Raw material approval is based on analytical test results and/or on COA/COC data. Quality
Assurance may consider the following options:
1) Approval - All tests and/or COA/COC values in specification.
2) Waiver - One or more tests and/or COA/COC values out of specification. (Waivers must
comply with the requirements described in CX-CP-6.01 Non-Conforming Material Handling)
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UNCONTROLLED COPY IF PRINTED
Identifier: CX-CP-2.01
Document Type: Corporate Procedure
Revision: 18
Title: Quality Assurance Approval of Raw Materials
Quality Assurance will notify the receiving personnel of the disposition of the raw material awaiting
approval. Quality Assurance approval is also recorded into SAP.
Rejection
Raw material rejection is based on analytical test results and/or on COA/COC data. Rejection
means one or more Approval to Receive parameters are out of specification. Quality Assurance
will notify the receiving personnel of the disposition of the raw material. Quality Assurance
rejection is also recorded into SAP. Quality Assurance should notify Procurement by initiating a
Corrective Action in the Corrective Action system when a raw material receipt is rejected.
Rejections shall be handled in accordance with CX-CP-6.01 "Non-Conforming Material Handling".
Retains
Quality Assurance will determine the need for a raw material retain. All samples shall
be properly contained, labeled, and stored per applicable sampling retain requirements.
REVISION HISTORY
Revision Date Revision Description Prepared By Approved
No By
1-15 Resides in legacy system R. Zwick
16 01/11/2018 Use new template and some minor Xinjun Fan Jim Beaulieu
updates
17 02/05/2020 Update company name and logo Xinjun Fan Jim Beaulieu
18 01/26/2022 Update company logo Xinjun Fan Jim Beaulieu
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