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Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for

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Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,

b) evaluating the need for action to prevent occurrence of nonconformities,

c) determining and implementing action needed,

d) records of results of action taken (see 4.2.4), and

e) reviewing the effectiveness of the preventive action taken.