Hi There,
Does anyone has an example of a traceability plan?
"These (traceability) plans shall define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location that:
a) enable the organization to identify nonconforming and/or suspect product;
b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the formal (electronic, hardcopy, archive) that enables the organization to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with safely/regulatory characteristics.
Thanks in advance
François
Does anyone has an example of a traceability plan?
"These (traceability) plans shall define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location that:
a) enable the organization to identify nonconforming and/or suspect product;
b) enable the organization to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the formal (electronic, hardcopy, archive) that enables the organization to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with safely/regulatory characteristics.
Thanks in advance
François