QP-33, Counterfeit, Fraudulent & Suspect Items

Revision Summary

Table of Contents

1.0          PURPOSE

This procedure prescribes the requirements for mitigating the introduction of Counterfeit, Fraudulent and Substandard Items (CFSI) items into Demtool’s manufacturing process, through prevention, detection, disposition and disposal of suspected CFSIs.

2.0          SCOPE AND APPLICABILITY

CFSI procedure provides the methods to mitigate presence of CFSIs through strategic procurement, inspection, control, disposition, training and awareness This procedure applies to all Nuclear orders.

3.0          OVERVIEW

CFSI is not a stand-alone process, but rather is a series of mitigating measures that are embedded in the quality management system activities, from accurately defining required material and items through to shipping to the customer.

3.1 ​ ​Definitions:

Item - any material, product, part, component, assembly liquid, gas, powder, raw stock etc.

Counterfeit: an item that has been intentionally manufactured or altered, to imitate a legitimate product without the legal right to do so.

Fraudulent- Items that are intentionally misrepresented with intent to deceive.

Suspect – Items that are suspected of being CFSI, based on visual inspection, testing or other information that may indicate non-conformance to established industry accepted specifications or national / international standards.

4.0 ​ ​RESPONSIBILITIES

The Quality Manager is responsible for the implementation and control of CFSI practices across Demtool, including awareness, training, prevention, detection, disposition, and notification to Customer. 

Purchasing Manager is responsible to ensure that personnel responsible for procurement, include in the requisitioning documents requirements to prohibit the use of CFSI.

Quality Control Inspectors performing inspection activities shall notify the Quality Manager of the potential or actual CFSI.

All Personnel discovering a CFSI shall notify the Quality Manager / Supervisor /QCI.

5.0 ​ ​PROCESS

5.1          Control of CFSI

Generally, CFSI is controlled through application of the quality management system, including, but not limited to:

·         Educating workers in CFSI;

·         Fostering a questionable attitude with all workers, enhancing Human Performance measures;

·         Applying Corrective Action process;

·         Including suppliers CFSI control evaluation, when qualifying suppliers;

·         Specifying control for CFSI to suppliers;

·         Only using qualified suppliers with history of good performance;

·         Only using raw material suppliers that represent, and purchase directly from, recognized mills;

·         Monitoring and auditing suppliers;

·         Attention to detail during receiving inspection and source surveillance, including returned items;

·         Sharing and using experience with respect to CFSI.

5.2          Examples of CFSI

Items may be CFSI when they exhibit indicators, such as:

• The item or raw material looks different in configuration, dimensions, fit, finish, color, or other attributes from that expected;
• Raw material surface condition is not what was expected;
• Raw material dimensions identified on material certifications are different that the raw material received;
• Marking or documentation from country other than of the supplier;
• The item does not look new or show evidence of prior use or repair;
• The item shows substandard workmanship;
• Altered manufacturer’s name, logo, serial number, manufacturing date;
• Marking on items, raw material or documentation are missing, unusual, altered, or inconsistent with what was expected;
• Documentation that appears altered, incomplete, or lack expected traceability, or manufacturer’s markings.

6.0          METHODS

6.1          Prevention

6.1.1     Questioning Attitude

The most effective way to detect CFSI is through employees performing purchasing, inspection, quality control, assessments / audits; they exhibit a questioning attitude, encouraged and supported by company management.

The general rule of CFSI is that the item should be questioned if it exhibits one or more of the indications described in 5.2 above.

6.2          CFSI Barriers

6.2.1     Purchasing

Purchases shall only be made from approved suppliers included in Approved Supplier List and who have a history of providing acceptable products.

To reduce the likelihood of receiving suspect/counterfeit items, prior to preparing the PO, the Purchasing will consider to:

•           Utilize Original Equipment Manufacturer;

•           Purchase from well-known suppliers;

•           Purchase from suppliers with a long - standing acceptable quality performance history.

The purchasing documents include information on suspect parts, to ensure supplier and subcontractor awareness, such as:

•           POs issued to the Demtool suppliers contain a statement prohibiting the delivery of CFSI

•           Impose observation or inspection hold points;

•           Specify inspections and/or tests to be witnessed by or performed by Demtool Quality Control Inspectors;

•           Specify the manufacturer or authorized distributor for items;

•           Require a pre-award survey of the supplier program and facility;

•           Require a post award audit;

•           Additional provisions necessary to verify compliance.

To support the Purchasing practices the Quality Manager reviews and concurs with Procurement requisitions and:

•           Maintains a listing of Suspect/Counterfeit items of concern and provides the list to personnel involved with CFSI controls to ensure use is prohibited (i.e. quality assurance, quality control, purchasing, personnel performing receiving activities);

•           Identifies known providers of CFSI items as “Prohibited” on the Approved Suppliers List.

•           Notifies the Customer when the CFSI supplier is discovered by Demtool.

6.2.2      Receiving Inspection

All received items are inspected for CFSI by trained QCIs. QC inspection of items is performed upon receipt in accordance with the receiving inspection requirements and this procedure to ensure that they are not CFSI.

Items and raw materials are verified against PO requirements and specified documentation (such as specifications, instructions, drawings), for identification and traceability markings and for CFSI conditions identified above.

The integrity of identification and traceability markings of raw material is a critical factor in ensuring the authenticity of the material and limiting the likelihood of CFSI material entering the manufacturing process.

Item that are received and inspected and are considered potential or actual CFSI shall be segregated, identified and processed in accordance with the nonconformance procedure (QP-13). 

6.2.3     Manufacturing

CFSI is mitigated while product is in manufacturing process, by strict adherence to identification and traceability requirements.

The machinists shall report any anomalies, unusual noise, cutting behavior, etc., that may indicate the material is not what it is supposed to be.

6.2.4     In Process and Final Inspection

QCI shall monitor manufacturing activities and shall ensure that unapproved material is not introduced into manufacturing process. This is achieved through visual confirmation that the material and parts are consistent in traceability markings, including control of transfer of markings, and this is properly documented in job router.

Final inspection verifies material marking against original material traceability of material test reports.

6.2.5     Packaging and Shipping

The shipper shall ensure the product identification is reflected on the packaging.

Photographs of items are taken for comparison against their receiving condition in the event the Customer suspects CFSI.

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6.3 ​ ​Disposition

Items determined to be CFSI are dispositioned by the Quality Manager, and other subject matter experts based on evaluation of impact to personnel, environment, equipment and operational impact.  Disposition is performed in accordance with QP-13.

Objective evidence associated with CFSI are processed per QP-19.

7.0          REFERENCES

QP-10, Control of Quality Records

QP-13, Control of Nonconformances;

EPRI1019163, Counterfeit, Fraudulent, and Substandard Items: Mitigating the. Increasing Risk

EPRI-NP-6629, Guidelines for the Procurement and Receipt of Items for Nuclear Power Plants

NQA-1, Quality Assurance Requirements for Nuclear Facility Applications

QP-33 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​Rev: 0