8.3 Controlof nonconforming product 不合格品的控制
8.3.1 General 總則
The organizationshall ensure that product which does not conform to product requirements is identifiedand controlled to prevent its unintended use or delivery. The organizationshall document a procedure to define the controls and related responsibilitiesand authorities for the identification, documentation, segregation, evaluationand disposition of nonconforming product.
組織應確保標識和控制不符合產(chǎn)品要求的產(chǎn)品從而阻止非預期的使用和交付。組織應當建立一個程序來明確用于控制以及界定、記錄、控制、隔離、評估（新增）、處置不合格品相應的職責和權限。
The evaluation of nonconformityshall include a determination of the need for an investigation and notificationof any external party responsible for the nonconformity.
不合格品的評估應包括明確的用于檢查的需求，并針對不合格盡責的向外部進行告知。（新增）
Records of thenature of the nonconformities and any subsequent action taken, including theevaluation, any investigation and the rationale for decisions shall bemaintained (see 4.2.5)
不合品的性質以及任何后續(xù)措施的相關記錄（包括評估、任何檢查和決定的理由）都應當予以保留。（見4.2.5）
8.3.2 Actions in response to nonconforming product detected before delivery 放行前不合格品的處置
The organizationshall deal with nonconforming product by one or more of the following ways:
組織應當通過以下一種或多種方式處理不合格品：
a) taking actionto eliminate the detected nonconformity;
采取措施以消除所發(fā)現(xiàn)的不合格；
b) taking actionto preclude its original intended use or application;
采取措施以阻止其原預期的使用或應用。
c) authorizingits use, release or acceptance under concession.
批準其讓步使用、放行或接收。
The organizationshall ensure that nonconforming product is accepted by concession only if the justificationis provided, approval is obtained and applicable regulatory requirements aremet. Records of the acceptance by concession and the identity of the personauthorizing the concession shall be maintained (see 4.2.5).
組織應當確保只有當能夠提供正當理由、獲得批準和符合相應法律法規(guī)要求的前提下，不合格產(chǎn)品才可以讓步接收。
8.3.3 Actions in response to nonconforming product detected after delivery
放行后不合格品的處置
Whennonconforming product is detected after delivery or use has started, theorganization shall take action appropriate to the effects, or potentialeffects, of the nonconformity. Records of actions taken shall be maintained(see 4.2.5).
當在銷售和開始后發(fā)現(xiàn)了不合格品，組織應當采取與影響或潛在影響相適應的不合品處理措施。處理措施的相關記錄應當予以保留。（見4.2.5）（新增）
The organizationshall document procedures for issuing advisory notices in accordance withapplicable regulatory requirements. These procedures shall be capable of beingput into effect at any time. Records of actions relating to the issuance ofadvisory notices shall be maintained (see 4.2.5).
組織應當建立依據(jù)相應法律法規(guī)要求發(fā)出忠告性通知的程序。這些程序應當在任何時候都能得以實施。與發(fā)布忠告性通知有關的措施的記錄應當予以保留。（見4.2.5）（新增）
8.3.4 Rework 返工
The organizationshall perform rework in accordance with documented procedures that takes into accountthe potential adverse effect of the rework on the product. These procedures shallundergo the same review and approval as the original procedure.
After thecompletion of rework, product shall be verified to ensure that it meetsapplicable acceptance criteria and regulatory requirements.
組織應當按照事先規(guī)定好的文件化的充分考慮了產(chǎn)品返工的潛在不利影響的程序進行返工。這些程序應當與原始程序一樣經(jīng)過審核和批準。返工完成后，應當對產(chǎn)品進行驗證以保證產(chǎn)品符合可接受標準和法律法規(guī)要求。
Records ofrework shall be maintained (see 4.2.5).
返工記錄應予以保留。（見4.2.5）