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Hello - I am looking for some guidance on the requirements in 8.3.3.3.
In the first sentence, the standard references special characteristics "determined by the customer" and "the risk analysis performed by the organization". Are the special characteristics determined by the organization (using the risk analysis) what most refer to as "internal special characteristics"?
b) (control and monitoring strategies) seems rather vague. Does anyone have additional insight on what is necessary to meet this requirement? Maybe some examples? Additionally, it reads, "... for special characteristics of products and production processes;" this reads like the SC can be a feature on the part, or it can be a process. But I don't see anywhere else in 8.3.3.3 where it references "production processes" as being Special Characteristics. Is the last part of "b)" actually making it a requirement to have at least some processes (not just part features) identified as Special Characteristics? If so, does anyone have any examples they could share?
c) (customer specified approvals). Would anyone have any examples, real or hypothetical, as to what this is?
8.3.3.3 Special Characteristics
The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:
a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents;
b) development of control and monitoring strategies for special characteristics of products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization's equivalent symbols or notations, as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer, if required.
In the first sentence, the standard references special characteristics "determined by the customer" and "the risk analysis performed by the organization". Are the special characteristics determined by the organization (using the risk analysis) what most refer to as "internal special characteristics"?
b) (control and monitoring strategies) seems rather vague. Does anyone have additional insight on what is necessary to meet this requirement? Maybe some examples? Additionally, it reads, "... for special characteristics of products and production processes;" this reads like the SC can be a feature on the part, or it can be a process. But I don't see anywhere else in 8.3.3.3 where it references "production processes" as being Special Characteristics. Is the last part of "b)" actually making it a requirement to have at least some processes (not just part features) identified as Special Characteristics? If so, does anyone have any examples they could share?
c) (customer specified approvals). Would anyone have any examples, real or hypothetical, as to what this is?
8.3.3.3 Special Characteristics
The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:
a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents;
b) development of control and monitoring strategies for special characteristics of products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization's equivalent symbols or notations, as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer, if required.