Preventive Actions

Definition of the term („What are preventive actions?“)

The ISO 9000 de­scri­bes a pre­ven­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a de­tec­ted fault or ano­t­her un­de­s­i­ra­ble si­tua­ti­on”. The pri­ma­ry ob­jec­ti­ve is to iden­ti­fy cau­ses of er­rors be­fo­re they oc­cur, to pre­vent them and thus make sure that an er­ror does not occur.

What is required as part of preventive actions?

The ISO 9001 calls for pre­ven­ti­ve ac­tions to eli­mi­na­te pos­si­ble cau­ses of er­rors to pre­vent them from oc­cur­ring. Mo­reo­ver, it re­qui­res that the re­sul­ting mea­su­res have to be matched to the scope of the pos­si­ble er­ror. Fur­ther­mo­re, a clear­ly do­cu­men­ted pro­ce­du­re is re­ques­ted with the fol­lowing scope:

  • Se­ar­ching for pos­si­ble er­rors and their causes
  • An eva­lua­ti­on of the ac­tion to pre­vent the pos­si­ble er­ror from occurring
  • Re­se­arch and im­ple­men­ta­ti­on of re­qui­red actions
  • Do­cu­men­ta­ti­on of the re­sults of the ac­tions taken
  • An eva­lua­ti­on of the ef­fec­ti­ve­ness of the ac­tions taken

Discover the suitable software for preventive measures

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

When are the preventive actions applied and required?

Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) are among the re­qui­red ele­ments of a GMP com­pli­ant pro­cess (QMS). Mo­reo­ver they are one of the most cri­ti­cal parts in au­dits. Ever sin­ce the in­tro­duc­tion of a QMS, it has be­co­me the ele­ment of a QMS which has po­sed the grea­test ob­sta­cles with re­gard to un­der­stan­ding, ac­cep­t­ance and im­ple­men­ta­ti­on across the company.

What is the difference between corrective actions 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 preventive actions

This pro­ce­du­re al­lows you to main­tain a high pro­duct qua­li­ty at all times as well as si­gni­fi­cant­ly re­du­ce cos­ts cau­sed by a pos­si­ble error.

Discover the suitable software for preventive measures

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GMP stands for “Good Ma­nu­fac­tu­ring Prac­ti­ce” or Ger­man “Gute Her­stell­pra­xis”. Thus, GMP con­tains po­li­ci­es and re­gu­la­ti­ons that al­ways have to be ob­ser­ved, if or­ga­niz­a­ti­ons deal

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