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Durability is characteristic of longevity. It can be described in following criterias as gamma-percentile lifetime e.t.c. and measured in the same units as reliability but till the limiting state. Reactions: Chennaiite
As per ISO 13485:2016 section 3.4: complaint Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a...
FDA Defination of Complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.
1. FAT, what Design/PFMEA tests are done in the factory and call out on the control plan for durability tests. 2. OSAT, same as above but look at what is called out or any at your disturbution, or a line setter at the factory where is your product is going to be used. 3.
CHARACTERISTIC, CRITICAL, CHRYSLER DEFINITION: Characteristics applicable to a component, material, assembly, or vehicle assembly operation which are designated by Chrysler Corporation Engineering as being critical to part function and having particular quality, reliability and/or durability significance.
It appears that you are making your definitions overly complicated and in conflict with ISO 9000 the normative (required) reference of AS9100 (see Sec. 2 & 3). Your registrar will hold you to the definition of Repair (3.6.9), and Rework (3.6.7) found in 9000.
Ford Speak: Acronyms, Definitions, and Terms Page 6 Destroy on or before 2000 Sep 1 2V - 3P 2V 1. Two Venturi carburetor
Definition of Special Processes • Special Processes result in components whose quality, reliability and durability may be compromised by potential variation in the process and the resulting defect is not feasibly detected prior to use
Significant Characteristic is a feature, dimension, or note that reasonably anticipated variation could affect principal fit, function, durability, customer satisfaction, or manufacturability. Any of those characteristics that affect a failure mode with a severity of 5 to 8 and an occurrence of 4 or higher must be reviewed to determine if they ...
Re: Diff between Customer Complaint and service Call as 13485 Lesson to be learned: If you don't have a sufficiently detailed and accurate procedure in place for effectively documenting and categorizing such contacts as they actually occur so that you can later defend your complaint data as having been validly distinguished from your non-complaint data...