Corrective Actions

Definition of the term („What is a corrective action?“) 

The ISO 9000 de­scri­bes a cor­rec­ti­ve ac­tion as a “me­a­su­re to eli­mi­na­te the cau­se of a de­tec­ted fault or an­o­ther un­de­si­ra­ble si­tua­ti­on”. Thus, the fo­cus is does not deal with the re­m­oval of faults e.g. by re­pair but ra­ther with de­tec­ting and eli­mi­na­ti­on cau­ses for faults in or­der to pre­vent the same faults from oc­cur­ring again.

What is required in corrective actions? 

The ISO 9001 asks for cor­rec­ti­ve ac­tions to eli­mi­na­te the cau­ses of er­rors with re­fe­rence to re­cur­rence. Mo­reo­ver, it re­qui­res that the re­sul­ting me­a­su­res have to be matched to the scope of the de­tec­ted er­ror. Fur­ther­mo­re, a cle­ar­ly do­cu­men­ted pro­ce­du­re is re­ques­ted with the fol­lo­wing scope:

a) Eva­lua­ti­on of er­rors (in­clu­ding cus­to­mer com­plaints),
b) De­ter­mi­ning the cau­ses of er­rors,
c) Eva­lua­ti­on of the re­qui­red ac­tions to pre­vent the re­cur­rence of er­rors,
d) De­fi­ni­ti­on of re­qui­red ac­tions and their im­ple­men­ta­ti­on,
e) Do­cu­men­ta­ti­on of the re­sults of the ac­tions ta­ken and
f) Eva­lua­ti­on of the ef­fec­ti­ve­ness of the cor­rec­ti­ve ac­tions taken.

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What is the difference between corrective and preventive actions?

Ge­ne­ral­ly, two dif­fe­rent pro­ce­du­res to pre­vent er­rors are dif­fe­ren­tia­ted. The cor­rec­ti­ve ac­tion on the one hand and the pre­ven­ti­ve ac­tion on the other hand.

If a fault or de­via­ti­on has al­re­a­dy been de­tec­ted, the fur­ther pro­ce­du­re is de­scri­bed as a cor­rec­ti­ve ac­tion in the form of an er­ror ana­ly­sis and eli­mi­na­ting me­a­su­re. Ho­we­ver, if no fault or de­via­ti­on has been de­tec­ted yet, but a pos­si­ble cau­se of er­rors has al­re­a­dy been iden­ti­fied, then the fol­lo­wing pro­ce­du­re is de­clared as a pre­ven­ti­ve action.

Benefits of corrective actions 

In­itia­ted cor­rec­ti­ve ac­tions fa­ci­li­ta­te the main­ten­an­ce and im­pro­ve­ment of pro­duct and ser­vice qua­li­ty as well as the qua­li­ty of the in­ter­nal pro­ces­ses and sta­bi­li­ze the­se aspects in the long run.

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Functional specification

De­fi­ni­ti­on of the term („What is a func­tion­al spe­ci­fi­ca­ti­on?“)  A func­tion­al spe­ci­fi­ca­ti­on con­ta­ins a contractor’s de­tail­ed de­scrip­ti­on how he in­tends to sol­ve the cus­to­mers requirements.

FDA 21 CFR Part 11

FDA 21 CFR Part 11 , the Ame­ri­can Food and Drug Ad­mi­nis­tra­ti­on (FDA) spe­ci­fies re­qui­re­ments for elec­tro­nic do­cu­ments, elec­tro­nic si­gna­tures and hand­writ­ten si­gna­tures ap­pli­ed to