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:

  1. Eva­lua­ti­on of er­rors (in­clu­ding cus­to­mer complaints),
  2. De­ter­mi­ning the cau­ses of errors,
  3. Eva­lua­ti­on of the re­qui­red ac­tions to pre­vent the re­cur­rence of errors,
  4. De­fi­ni­ti­on of re­qui­red ac­tions and their implementation,
  5. Do­cu­men­ta­ti­on of the re­sults of the ac­tions ta­ken and
  6. Eva­lua­ti­on of the ef­fec­ti­ve­ness of the cor­rec­ti­ve ac­tions taken.

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.

Discover the suitable software for your corrective actions

Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses such as Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) with our di­gi­tal work­flows. Our in­te­gra­ted so­lu­ti­ons ma­na­ge your pre­vious­ly pa­per-bound pro­cess from cap­tu­re to com­ple­ti­on com­ple­te­ly digitally.
Live insight into the GxP-compliant document management system by d.velop Life Sciences

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