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Re: What is the proper definition for Class 1 & 2 nonconformances
here is what we use....... I tried to attach teh file but kept getting an "invalid file" error so I had to paste it...sorry
Change Classes
Class I Changes
Changes will be classified as Class I, in accordance with definitions set forth in MIL-STD-973. An engineering change will be classified Class I when one or more factors below are affected:
a. functional or allocated configuration identification;
b. product configuration identification;
c. technical requirements;
d. non-technical contractual provisions;
e. other factors:
1) government furnished equipment;
2) safety;
3) electromagnetic characteristics;
4) operational;
5) compatibility with support equipment;
6) configuration to the extent that retrofit action would be required;
7) delivered operation and maintenance manuals;
8) pre-set adjustments or schedule affecting operating limits or performance to such extent as to require assignment of a new identification number;
9) interchangeability, substitutability or replace ability as applied to items, excluding the pieces and parts of non-repairable sub-assemblies;
10) sources of items or repairable items defined by source control drawings;
11) skills, manning, training, biomedical factors or human engineering design
If required by contract, company will not implement a compatibility engineering change with an effectivity after the establishment of the baseline configuration without prior approval of the customer. company will submit the proposed Class I compatibility engineering change as an expedited ECP.
Compatibility engineering changes with effectivity after delivery of the first unit and prior to the establishment of the baseline configuration may be implemented by company provided there is no impact to interfacing equipment. If determination of interface effects is uncertain, and if the contract between company and the customer requires it, the proposed corrective action will be coordinated with the customer and will have customer approval prior to incorporation,
If required by contract, company will submit a Notice of Revision (NOR) to the customer following initiation of corrective action which will be followed by submission of a formal routine ECP.
company will submit a copy of Class I changes to the customer for concurrence with classification and/or approval. company will also submit a reproducible of each Class I ECP, as required by the applicable customer data document and contract.
Class I changes will be incorporated at the earliest possible effectivity authorized by the customer.
Class II Changes
An engineering change will be classified Class II when it does not fall within the definition of a Class I. Examples of a Class II engineering change are:
a) a change in documentation only (e.g., correction of errors, addition of clarifying notes or views;
b) a change in hardware (e.g., substitution of an alternative material) which does not affect any Deviation requirement factors;
c) changes that do not affect form, fit, or function
When an engineering change is classified as a Class II change, Atlantic certifies that all factors for a Class I change were considered and the factors are not applicable.
If it is later determined that the factors for a Class I change are applicable, the company, at the direction of the customer, will cancel the Class II change in its entirety. Company may reprocess the engineering change as a Class I change.
Unless otherwise specified by contract or purchase order, Class II changes are not submitted to the customer for approval but are available for review and surveillance by the customer’s Configuration Management or Quality Assurance Representative for concurrence as to classification.
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