Preventive actions

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

In ISO 9000, a pre­ven­ti­ve ac­tion is de­scri­bed as an “ac­tion to eli­mi­na­te the cau­se of a pos­si­ble er­ror or other pos­si­ble un­de­si­ra­ble si­tua­ti­on”. In this re­spect, the pri­ma­ry aim is to iden­ti­fy and pre­vent the cau­ses of er­rors be­fo­re they oc­cur and to en­su­re that er­rors the­r­e­fo­re do not occur .

What is required within preventive actions? 

ISO 9001 re­qui­res pre­ven­ti­ve ac­tions to eli­mi­na­te pos­si­ble cau­ses of er­rors in or­der to pre­vent their oc­cur­rence. Fur­ther­mo­re, it is re­qui­red that the re­sul­ting ac­tions are ad­apt­ed to the size of the pos­si­ble er­ror. In ad­di­ti­on to that, a clear and do­cu­men­ted pro­ce­du­re is re­qui­red, which in­cludes the following:

• Sear­ching for pos­si­ble er­rors and the re­asons for them
• Eva­lua­ti­on of the ne­ces­si­ty of the ac­tion to avo­id the po­ten­ti­al er­ror oc­cur­rence
• Re­se­arch and rea­liza­ti­on of ne­ces­sa­ry me­a­su­res
• Do­cu­men­ta­ti­on on the re­sults of the ac­tion ta­ken
• Eva­lua­ti­on of the ef­fec­ti­ve­ness of the ac­tion taken

What are the benefits of preventive actions? 

On the one hand, this ap­proach en­ables the qua­li­ty of the pro­ducts to be kept at a con­sis­t­ent­ly high le­vel and, on the other hand, it sa­ves con­sidera­ble cos­ts that a pos­si­ble er­ror would cause .

When are preventive actions applied and required? 

Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tion (CAPA) are among the man­da­to­ry com­pon­ents of GMP-com­pli­ant work (QMS). They are also con­side­red to be one of the cri­ti­cal sub­ject are­as du­ring in­spec­tions. Sin­ce the in­tro­duc­tion of QMS, it has ma­ni­fes­ted its­elf as the ele­ment of a QMS that pres­ents the grea­test hurd­les in terms of un­der­stan­ding, ad­op­ti­on, and com­pa­ny-wide implementation .

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and, thus, map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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Steps to implement corrective actions

The im­ple­men­ta­ti­on of pre­ven­ti­ve ac­tions re­qui­res a struc­tu­red ap­proach. Here are some steps you can follow:

  • Risk eva­lua­ti­on: Iden­ti­fy po­ten­ti­al risks and dan­gers in your pro­cess or pro­duct. This can be done th­rough ana­ly­sis, au­dits and observations. 
  • Me­a­su­re plan: De­ve­lop a clear plan to mi­ni­mi­ze or eli­mi­na­te the­se risks. This may in­clude up­dating pro­ce­du­res, trai­ning em­ployees, or im­pro­ving processes. 
  • Im­ple­men­ta­ti­on: Put your ac­tion plan into prac­ti­ce and en­su­re that all re­le­vant em­ployees are trai­ned and informed. 
  • Mo­ni­to­ring and me­a­su­re­ment: Track the re­sults of your pre­ven­ti­ve ac­tions and check re­gu­lar­ly to see if they are ef­fec­ti­ve. Ad­just the plan if necessary. 
  • Con­ti­nuous im­pro­ve­ment: Use the coll­ec­ted data and in­sights to make con­ti­nuous im­pro­ve­ments and op­ti­mi­ze your qua­li­ty ma­nage­ment system.

What is the difference between corrective and preventive actions? 

The­re are ge­ne­ral­ly two dif­fe­rent pro­ce­du­res for avo­i­ding er­rors. One pro­ce­du­re is the cor­rec­ti­ve ac­tion and the other is the pre­ven­ti­ve action.

If an er­ror or de­via­ti­on has al­re­a­dy been de­tec­ted, the fur­ther pro­ce­du­re is de­scri­bed in the form of an er­ror ana­ly­sis and cor­rec­ti­ve ac­tion. Ho­we­ver, if no error/deviation has been de­tec­ted yet, but a pos­si­ble source of er­ror has been iden­ti­fied in ad­van­ce, then sub­se­quent pro­ces­ses are de­clared as a pre­ven­ti­ve action.


Im­ple­men­ting pre­ven­ti­ve ac­tions in ac­cordance with ISO 9001 can bring con­sidera­ble be­ne­fits to your com­pa­ny. They do not only help pre­vent qua­li­ty pro­blems, but also con­tri­bu­te to in­creased cus­to­mer sa­tis­fac­tion and cost ef­fi­ci­en­cy. A proac­ti­ve ap­proach to qua­li­ty assu­rance is cri­ti­cal to suc­cee­ding in today’s com­pe­ti­ti­ve busi­ness environment.

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Frequently Asked Questions (FAQs)

What is ISO 9001?
ISO 9001 is an in­ter­na­tio­nal stan­dard for qua­li­ty ma­nage­ment sys­tems that aims to in­crease cus­to­mer sa­tis­fac­tion and im­pro­ve a company’s efficiency.

Why are pre­ven­ti­ve ac­tions im­portant?
Pre­ven­ti­ve ac­tions are im­portant to avo­id po­ten­ti­al qua­li­ty pro­blems, re­du­ce cos­ts, and in­crease cus­to­mer confidence.

How do I iden­ti­fy po­ten­ti­al risks in my com­pa­ny?
Po­ten­ti­al risks can be iden­ti­fied th­rough ana­ly­ses, au­dits and observations.

What steps are re­qui­red to im­ple­ment pre­ven­ti­ve ac­tions?
The steps for im­ple­men­ting pre­ven­ti­ve ac­tions in­clude risk eva­lua­ti­on, ac­tion plan, im­ple­men­ta­ti­on, mo­ni­to­ring and me­a­su­re­ment, and con­ti­nuous improvement.

What are the be­ne­fits of im­ple­men­ting pre­ven­ti­ve ac­tions?
Im­ple­men­ting pre­ven­ti­ve ac­tions can lead to the pre­ven­ti­on of qua­li­ty pro­blems, cost sa­vings, and in­creased cus­to­mer satisfaction.

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Document Management System (DMS)

De­fi­ni­ti­on of the term (“What is a Do­cu­ment ma­nage­ment sys­tem (DMS)?” A do­cu­ment ma­nage­ment sys­tem (DMS) can be un­ders­tood as the ma­nage­ment of elec­tro­nic documents

Corrective action

De­fi­ni­ti­on of the term (“What is a cor­rec­ti­ve ac­tion?”) In ISO 9000, a cor­rec­ti­ve ac­tion is de­scri­bed as “ac­tion ta­ken to eli­mi­na­te the cau­se of