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 a de­tec­ted er­ror or other un­de­si­ra­ble si­tua­ti­on”. In this re­spect, it is less a ques­ti­on of rec­ti­fy­ing the er­ror, e.g. by me­ans of cor­rec­tion, but ra­ther of re­co­gni­zing and eli­mi­na­ting the cau­ses of er­rors so that iden­ti­cal er­rors do not oc­cur again.

What is required within corrective actions? 

ISO 9001 re­qui­res cor­rec­ti­ve ac­tions to eli­mi­na­te cau­ses of er­rors with re­gard to a re­pea­ted oc­cur­rence. Fur­ther­mo­re, it is re­qui­red that the re­sul­ting ac­tions are ad­apt­ed to the size of the er­ror that has oc­cur­red. In ad­di­ti­on to that, a clear do­cu­men­ted pro­ce­du­re is re­qui­red, which in­cludes the following:

a) Er­ror eva­lua­ti­on (in­clu­ding cus­to­mer com­plaints),
b) Iden­ti­fy­ing the cau­ses of er­rors,
c) Eva­lua­ti­on of the need for ac­tion to pre­vent the re­cur­rence of er­rors,
d) De­ter­mi­na­ti­on of ne­ces­sa­ry ac­tions and their rea­liza­ti­on,
e) Do­cu­men­ta­ti­on of the re­sults of the ac­tions ta­ken, and
(f) Eva­lua­ti­on of the ef­fec­ti­ve­ness of cor­rec­ti­ve ac­tions taken.

What are the benefits of corrective action? 

Im­ple­men­ting cor­rec­ti­ve ac­tions ac­cor­ding to ISO 9001 of­fers se­ve­ral be­ne­fits for your com­pa­ny. First, it helps to iden­ti­fy and cor­rect qua­li­ty is­sues ear­ly, be­fo­re they be­co­me ma­jor pro­blems. Se­cond, it con­tri­bu­tes to con­ti­nuous im­pro­ve­ment by en­ab­ling lear­ning from er­rors and op­ti­mi­zing processes.

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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

  • Iden­ti­fi­ca­ti­on of the pro­blem: The first step of im­ple­men­ting cor­rec­ti­ve ac­tions is to iden­ti­fy the pro­blem. This can be done th­rough in­ter­nal au­dits, cus­to­mer feed­back, or other qua­li­ty con­trol procedures. 
  • Root cau­se ana­ly­sis: Af­ter the pro­blem has been iden­ti­fied, it is im­portant to ana­ly­ze the cau­ses. This helps to en­su­re that the pro­blem does not reoccur. 
  • Me­a­su­re plan­ning: Ba­sed on the root cau­se ana­ly­sis, an me­a­su­re plan should be crea­ted. This plan should cle­ar­ly de­fi­ne what steps will be ta­ken to ad­dress the problem. 
  • Im­ple­men­ta­ti­on of me­a­su­res: The next step is the im­ple­men­ta­ti­on of the plan­ned me­a­su­res. This may in­clude trai­ning, pro­cess ch­an­ges, or other activities. 
  • Mo­ni­to­ring and re­view: Once the ac­tions have been im­ple­men­ted, it is im­portant to mo­ni­tor pro­gress and en­su­re that the pro­blem has ac­tual­ly been solved. 
  • Do­cu­men­ta­ti­on: All steps in the cor­rec­ti­ve ac­tion pro­cess should be careful­ly do­cu­men­ted to fa­ci­li­ta­te track­ing and reviewing.

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 one 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.

Conclusion

The im­ple­men­ta­ti­on of cor­rec­ti­ve ac­tions in ac­cordance with ISO 9001 is cru­cial for main­tai­ning high qua­li­ty stan­dards in your com­pa­ny. By iden­ti­fy­ing and ad­dres­sing qua­li­ty is­sues, you can build cus­to­mer con­fi­dence and en­su­re long-term suc­cess. Re­mem­ber that careful plan­ning and do­cu­men­ta­ti­on are cri­ti­cal to the suc­cess of this process.

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Frequently Asked Questions (FAQs)

What is the pur­po­se of cor­rec­ti­ve ac­tions ac­cor­ding to ISO 9001?
Cor­rec­ti­ve ac­tions are used to iden­ti­fy and cor­rect qua­li­ty pro­blems to en­su­re com­pli­ance with qua­li­ty standards.

What are the be­ne­fits of im­ple­men­ting cor­rec­ti­ve ac­tions?
The im­ple­men­ta­ti­on of cor­rec­ti­ve ac­tions en­ables the ear­ly de­tec­tion and eli­mi­na­ti­on of qua­li­ty pro­blems as well as the con­ti­nuous im­pro­ve­ment of processes.

How should cor­rec­ti­ve ac­tions be do­cu­men­ted?
Cor­rec­ti­ve ac­tions should be careful­ly do­cu­men­ted, in­clu­ding the iden­ti­fi­ca­ti­on of the pro­blem, root cau­se ana­ly­sis, ac­tion plan, and im­ple­men­ta­ti­on steps. The ea­sie­st way to achie­ve this is with ap­pro­pria­te QM soft­ware so­lu­ti­ons.

How of­ten should in­ter­nal au­dits be con­duc­ted to iden­ti­fy qua­li­ty is­sues?
In­ter­nal au­dits should be con­duc­ted re­gu­lar­ly to iden­ti­fy qua­li­ty is­sues ear­ly. Fre­quen­cy may vary de­pen­ding on busi­ness needs.

What role does ISO 9001 play in cor­rec­ti­ve ac­tions?
ISO 9001 sets the stan­dards for qua­li­ty ma­nage­ment and pro­vi­des gui­de­lines for im­ple­men­ting cor­rec­ti­ve ac­tions in ac­cordance with in­ter­na­tio­nal best practices.

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