In quality domain, unqualified with blemish it is two very main ideas, also be two very easy and promiscuous concepts, understand their immanent meaning and distinction correctly, begin examine and verify of quality management system systematic level, correctly to understanding quality management to having very main effect.
Unqualified with blemish it is two very easy and promiscuous concepts, often mix in numerous press with, for example in the report about some number camera, see namely " share 6 camera to be sentenced to be rejected product, but this company refuses recall blemish watch for an opportunity " model of written characters. Although be in concerned code, of these two concepts state sometimes very not clear also, for example blemish of product of lieutenant general of regulation of government of recall of some blemish product is limitted for " because design, the endangers security of person, belongings unreasonable risk that creates what wait for the reason of the respect and exist generally in the product of some batch, model or category to have oneness, the case that perhaps does not accord with the national level that concerns this product safety " . Accurate understanding these two concepts, alignment understands ISO9000 truly a group of things with common features standard and beginning examine and verify effectively to work is very important undoubtedly.
" standard of quality of product of People's Republic of China " thirtieth sets 4 times: "Blemish is the unreasonable risk that shows product presence endangers security of belongings of person, other; The product has the national level that ensures safety of human body health and person, belongings, occupation standard, it is to point to do not accord with this standard " . The United States " tort act law restatements " 402A maintain blemish for " right the blemish state that the person that use or consumer or its belongings have unreasonable risk " . The European Union concerns rule rule to think: The product has the degree of safety that authority expects without people, it is defective.
Can see from this, concerned code is blemish definition the security with reasonable lack commonly
Will unqualified (do not accord with) the definition adds up to standard, code or other requirement to not agree with, the definition in this and ISO9000 standard is fundamental it is consistent.
According to the definition of ISO9000 standard, unqualified product is to point to not contented bright show or the product of the requirement that must fulfil and expectation, perhaps did not satisfy the product of the demand with implicit customarily and expectation, this kind " customarily is implicit " meaning and " bright show " the meaning is very adjacent already, just know because of everybody, self-evident not need consequently formerly " say " come out.
And defective product is the requirement that be aimed at what its anticipate or sets utility, if be put in inadequacy and this kind of inadequacy is not bright show or code sets, say its have drawback. Understand from this, the design verification of the product is to solve a design to go up to whether have unqualified (because the test and verify of design and development is to ensure design and development output are contented of the input,ask, and design and development input requirement are those bright show reach the requirement that must fulfil and expectation) , and the design of the product affirms is to solve a design to go up to whether have drawback (because design,admitting really with development is to ensure the product can satisfy use requirement of the regulation or foregone anticipation of utility requirement) .
ISO9000 standard defines about blemish in noting special remind: "Divisional blemish and unqualified concept are important, because have legal intention among them,this is, be in especially the respect that concerns with product and service liability issue. Accordingly, term ' blemish ' Ying Shen is used " . Because blemish is the blemish that the unreasonable risk that shows product presence endangers security of belongings of person, other perhaps uses,this is, once decide,some product is put in blemish, the legal responsibility that unqualified place should assume the legal responsibility that the agree of the person that offer of the product carries and product is different. According to normally legal provision, product quality occurrence problem belongs to the goods that did not agree according to the contract consign is eligible, it is behavior of break a contact; The product of place consign has blemish to belong to product liability, suffer goods to just can choose lawsuit. And the state that once appear,harms, the person that the product is offerred will assume entire legislation responsibility, the court decision also will be very severe. Is California dweller pulled unconscious? Luo Mofu Fu drives racing bike of exercise of division of grand of paragraph Ford cloth was taking 3 child to go out 1978, in California door of metropolis Sa carat holds the high speed around in the palm traffic accident produces when the travel on the road, the car overturns after bumping into highway to keep apart column, because roof extruding brings about a couple,two as young as sons die on the spot, additionally 2 daughters on the car are swung outside dispatch a vehicle and sufferred an injury. Eldest son You An of Luo Mo and two little sisters tell Ford company the court accordingly, design with this car unreasonable do not bear fruit with roof material and bring about the member that multiply for death, requirement Ford company makes compensation. A jury of California place court made requirement Ford company compensate for 1999 2. The court decision of 9.5 billion dollar, american California high court entered a judgement 2002, maintain the trial result of local court.
Those who need an attention is: Blemish is in the light of what anticipate or the requirement that sets utility, here " anticipate " it is to point to reasonable, normal (what can offer reference is ISO9001 standard in the requirement that outputs about design and development, the security that the standard provides to the output that design and develops should provide pair of products and the item characteristics that use place to need normally) , have not at " abuse " case. An example can be used at the explanation what to is meant by " abuse " , some famous computer production company ever had received to complain, complainant says: This computer is other the respect is very good, it is coffee is held in the palm use appear before long problem. This company expedites an engineer to look, so this client does not know the computer, regard CD driver as the bracket that puts coffee is used, and very fast CD driver bang up.
Such issues came, is everybody thinks next product examine and verify discovery unqualified be still blemish? Welcome everybody to be in leave a message!