Introduction

Resulting from a CQM Audit the CQM Auditor reports Audit Findings. An Audit Finding is a statement that describes what the CQM Auditor observed during the CQM Audit.

CQM distinguishes different types of Audit Findings:

  • Recommended Improvements ("RI")
  • Minor Non-Conformity ("nc-")
  • Major Non-Conformity ("NC+")
  • Critical Non-Conformity ("NCC")

These types are defined below:

Definition of Types of Audit Findings

Recommended Improvement ("RI")

A Recommended Improvement is every Audit Finding where the CQM Auditor believes that the Vendor should improve product or process but did not identify a Non-Conformity with the CQM requirements.

Examples for a Recommended Improvement:

  • The Vendor controls a certain product characteristic manually at the required sampling rate and conform with the applicable CQM requirements. The CQM Auditor believes that while the manual control appears compliant, an automated control would be more efficient and effective. The CQM Auditor recommends replacing the manual control with an automated control.
  • The Vendor describes a control in a procedure. Even though the operators conducting the control do so in a CQM conform way, the CQM Auditor recommends that the control should be better described to ease understanding of the documented procedure.
  • Limits for controlling a product characteristic are more stringent than required by the applicable CQM requirements, and CQM Auditor gains the impression that this results in unnecessary yield loss. The CQM Auditor recommends making the limits less stringent to increase yield without affecting conformity of the resulting product.

Note: Recommended Improvements do not affect the Grade resulting from the CQM Audit.

Minor Non-Conformity ("nc-")

A Minor Non-Conformity is an Audit Finding where the CQM Auditor observed that a product or process is not conform with the applicable CQM requirements, but the CQM Auditor has concluded that the non-conformity will not affect the quality of the product in the field.

Examples for a Minor Non-Conformity:

  • The vendor documents in one document a reference to another document. The reference in the document is incorrect, but the CQM Auditor determines that the person needing the referenced information has access to the correct document and uses the correct document. The auditor requests that the reference is corrected.
  • The Vendor conducts a control in production, but the control is not properly documented, for example not in the Control Plan.
  • The Vendor conducts a sampling control in production with control limits that are too lenient to ensure conformity of the product with the applicable CQM requirements, but the CQM Auditor determines that a subsequent 100% control ensures that no products not conforming with the applicable requirements prevent any escapees into subsequent processes.

Note: The number of Minor Non-Conformities may affect the Grade resulting from the CQM Audit. A large number of Minor Non-Conformities prevents Grade A. An excessive number of Minor Non-Conformities prevents Grade B.

Major Non-Conformity ("NC+")

A Major Non-Conformity is an Audit Finding where the CQM Auditor observed that a product or process is not conform with the applicable CQM requirements, and the CQM Auditor has not concluded that the non-conformity will not affect the quality of the product in the field.

Examples for a Major Non-Conformity:

  • The vendor documents in one document a reference to another document. The reference in the document is incorrect, resulting in the person needing the referenced information not having access to it. The auditor requests that the reference is corrected.
  • The Vendor does not conduct a control that is required by the CQM requirements or by the Vendor's Control Plan.
  • The Vendor conducts a sampling control in production with control limits that are too lenient to ensure conformity of the product with the applicable CQM requirements, potentially resulting in non-conforming products being forwarded to subsequent processes.
  • The Vendor did not qualify conformity with a certain applicable CQM requirement during qualification of the product, but the CQM Auditor determines that the production process contains sufficient controls to ensure that all products forwarded to subsequent processes are conform with the applicable CQM requirement.

Note: The number of Major Non-Conformities affects the Grade resulting from the CQM Audit. A single Major Non-Conformity prevents Grade A. Multiple Major Non-Conformities prevent Grade B. A large number of Major Non-Conformities results in withdrawal and prevents (re-)issuance of the affected CQM label.

Critical Non-Conformity ("NCC")

A Critical Non-Conformity is an Audit Finding where the CQM Auditor observed that the Vendor has never verified that a product is conform with the applicable CQM requirements.

Examples for a Critical Non-Conformity:

  • The Vendor did not qualify conformity with a certain applicable CQM requirement during qualification of the product, and the CQM Auditor did not determine that the production process contains sufficient controls to ensure that all products forwarded to subsequent processes are conform with the applicable CQM requirement.

Note: A single Critical Non-Conformity results in withdrawal and prevents (re-)issuance of the affected CQM label.

 

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