Standard Operating Procedure (SOP)

Definition of the term (“What is a SOP?”) 

Stan­dard ope­ra­ting pro­ce­du­res (SOPs) are writ­ten do­cu­ments that pro­vi­de de­tail­ed in­s­truc­tions for spe­ci­fic work pro­ces­ses in a com­pa­ny or or­ga­niza­ti­on. The­se in­s­truc­tions are for­mu­la­ted to help em­ployees per­form tasks in a con­sis­tent and ef­fi­ci­ent man­ner. SOPs are wi­de­ly used in va­rious in­dus­tries, in­clu­ding ma­nu­fac­tu­ring, he­alth­ca­re, IT, and many others. The use of SOPs en­su­res that all pro­ce­du­res are car­ri­ed out con­sis­t­ent­ly and com­ply with cur­rent standards.

The significance of SOPs

SOPs play a cri­ti­cal role in en­su­ring that a com­pa­ny ope­ra­tes smooth­ly. Here are some im­portant re­asons why they are of gre­at significance:

  • Con­sis­ten­cy and qua­li­ty assu­rance: Using SOPs en­su­res that all em­ployees fol­low the same stan­dards and pro­ce­du­res. This leads to con­sis­tent qua­li­ty in the ser­vices or pro­ducts provided. 
  • In­cre­asing ef­fi­ci­en­cy: SOPs de­fi­ne clear steps and re­spon­si­bi­li­ties thus ma­king work pro­ces­ses more ef­fi­ci­ent. Em­ployees know exact­ly what is ex­pec­ted of them thus sa­ving time and resources. 
  • Trai­ning and on­boar­ding trai­ning: SOPs can be va­luable trai­ning tools for new em­ployees. They enable fas­ter on­boar­ding trai­ning and mi­ni­mi­ze the risk of errors. 
  • Com­pli­ance and se­cu­ri­ty: In some in­dus­tries, SOPs are re­qui­red by law to en­su­re com­pli­ance with re­gu­la­ti­ons and safe­ty standards. 

How do you create effective SOPs?

Crea­ting ef­fec­ti­ve SOPs re­qui­res care and pre­cis­i­on. Here’s a step-by-step gui­de to crea­ting high-qua­li­ty SOPs:

  • Step 1: Iden­ti­fy the pro­cess
    Sel­ect the work pro­cess for which you want to crea­te an SOP. Cle­ar­ly de­fi­ne what this pro­cess includes. 
  • Step 2: Gather in­for­ma­ti­on
    Talk to em­ployees who al­re­a­dy know the pro­cess to gather all re­le­vant in­for­ma­ti­on. Note down all the steps and details. 
  • Step 3: For­mu­la­te clear in­s­truc­tions
    Wri­te the in­s­truc­tions in simp­le, un­der­stan­da­ble lan­guage. Avo­id jar­gon and com­pli­ca­ted sentences. 
  • Step 4: Vi­sua­li­ze the pro­cess
    Use dia­grams, flow­charts, or graphs to vi­sual­ly re­pre­sent the pro­cess. This fa­ci­li­ta­tes understanding. 
  • Step 5: Trai­ning of the em­ployees
    En­su­re that all af­fec­ted em­ployees tho­rough­ly un­der­stand the SOPs. This re­qui­res trai­ning and edu­ca­tio­nal ma­te­ri­als to en­su­re ever­yo­ne is on the same page. 
  • Step 6: Test, mo­ni­tor and up­date the SOP
    Have sel­ec­ted em­ployees per­form the pro­cess using the SOP and ac­cept feed­back. SOPs should not be set in stone. It is im­portant to re­view them re­gu­lar­ly and up­date them as nee­ded to en­su­re they meet chan­ging re­qui­re­ments and best practices.

An SOP is do­cu­men­ted in a hand­book. It con­ta­ins a di­stinct ID, a ver­si­on num­ber, a date or pe­ri­od of va­li­di­ty and the names and si­gna­tures of the crea­tor, ap­pro­ver and re­leaser. This in­for­ma­ti­on en­su­res a com­pre­hen­si­ve tracea­bi­li­ty of a do­cu­ment. Mo­reo­ver, it must be re­cor­ded that the em­ployees of the or­ga­niza­ti­on were in­for­med of the con­tent of an SOP and must be no­ti­fied in case of a ch­an­ge to an SOP.

Discover the right software for your SOP management

Whe­ther work / pro­cess in­s­truc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­s­truc­tions, con­tracts or any other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them di­gi­tal­ly with our “Do­cu­ment Con­trol” mo­du­le. Com­pli­ant with ISO stan­dards, EU-GMP, FDA CFR & more.

Live insight into the GxP-compliant document management system of Digital Life Sciences

SOPs in practice

A good ex­am­p­le of the ap­pli­ca­ti­on of SOPs is a me­di­cal la­bo­ra­to­ry. Here, SOPs are es­sen­ti­al to en­su­re that tests are per­for­med cor­rect­ly. Each step, from sam­ple ma­nage­ment to ana­ly­sis, is pre­cis­e­ly de­fi­ned to en­su­re ac­cu­ra­cy and safety.

In which sectors/industries is it required? 

They are a re­qui­re­ment for the of­fi­ci­al ap­pr­oval, espe­ci­al­ly in the phar­maceu­ti­cal in­dus­try. This espe­ci­al­ly af­fects the cer­ti­fi­ca­ti­on of pro­ducts and ser­vices. Sin­ce this is a re­gu­la­to­ry ap­pr­oval, the aut­ho­ri­ty also checks the con­tent. It is in­ves­ti­ga­ted whe­ther the­re are vio­la­ti­ons of cor­re­spon­ding pro­ce­du­res. If this is the case, this can re­sult in va­rious con­se­quen­ces down to the pro­hi­bi­ti­on of sel­ling pro­duct or services.

What are the advantages of SOPs? 

Due to the pos­si­ble aut­ho­ri­ta­ti­ve sanc­tions, stan­dard ope­ra­ting pro­ce­du­res are stron­ger than or­di­na­ry work in­s­truc­tions de­scrib­ing the pro­ce­du­res wi­thin an or­ga­niza­ti­on etc. Other ad­van­ta­ges of elec­tro­ni­cal­ly ma­na­ged SOPs (made pos­si­ble by the Do­cu­ment Con­trol mo­du­le) include:

  • Ve­ri­fi­ca­ti­on and re­lease pro­ces­ses con­troll­able with workflows
  • Com­pre­hen­si­ve do­cu­ment ma­nage­ment incl. versioning
  • Com­pli­ance with all requirements/regulations
  • Elec­tro­nic ma­nage­ment of your spe­ci­fi­ca­ti­ons (e.g. work /process in­s­truc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans, ope­ra­ting in­s­truc­tions), form sheets, con­tracts and other do­cu­ment types
  • Re­duc­tion of pro­cess run­times for crea­ti­on, re­vi­si­on, re­lease and dis­tri­bu­ti­on of specifications
  • Easy dis­tri­bu­ti­on of do­cu­ments and use of the si­gna­tu­re circulation
  • Re­duc­tion of un­neces­sa­ry prin­touts and paper

Conclusion

Stan­dard ope­ra­ting pro­ce­du­res (SOP) are a powerful tool for op­ti­mi­zing work pro­ces­ses. They in­crease ef­fi­ci­en­cy, qua­li­ty and safe­ty in com­pa­nies and or­ga­niza­ti­ons. Crea­ting and main­tai­ning SOPs ta­kes time and com­mit­ment, but pays off in the form of smooth pro­ces­ses and sa­tis­fied customers.

Start your digital transformation with our powerful, modular SOP management software solution

Frequently asked questions (FAQs) — Standard Operating Procedure (SOP)

Stan­dard ope­ra­ting pro­ce­du­res (SOPs) are cru­cial for qua­li­ty assu­rance, ef­fi­ci­en­cy and safe­ty in com­pa­nies. They en­su­re con­sis­tent stan­dards, make it ea­sier to train new em­ployees and help with com­pli­ance, espe­ci­al­ly in re­gu­la­ted sec­tors such as the life sci­en­ces in­dus­try. SOPs pro­mo­te trans­pa­rent pro­ces­ses and in­crease com­pe­ti­ti­ve­ness th­rough ope­ra­tio­nal excellence.

The crea­ti­on of stan­dard ope­ra­ting pro­ce­du­res (SOPs) is ex­tre­me­ly va­luable in va­rious in­dus­tries and pro­mo­tes the ef­fi­ci­en­cy, uni­for­mi­ty and qua­li­ty assu­rance of ope­ra­tio­nal pro­ces­ses. Espe­ci­al­ly in re­gu­la­ted in­dus­tries such as phar­maceu­ti­cals and me­di­cal tech­no­lo­gy, SOPs are es­sen­ti­al for stan­dar­di­zing in­ter­nal pro­ces­ses. They are also im­portant in other are­as such as fi­nan­cial ser­vices or pro­duc­tion to en­su­re ope­ra­tio­nal ef­fi­ci­en­cy. Spe­ci­fic SOPs for dif­fe­rent busi­ness are­as pro­mo­te trans­pa­ren­cy and sup­port the di­gi­tal trans­for­ma­ti­on. The crea­ti­on of SOPs is the­r­e­fo­re cru­cial for pro­cess op­ti­miza­ti­on and a company’s com­pe­ti­ti­ve advantage.

The do­cu­ment con­trol soft­ware so­lu­ti­on from Di­gi­tal Life Sci­en­ces GmbH en­ables the ef­fi­ci­ent crea­ti­on and ma­nage­ment of stan­dard ope­ra­ting pro­ce­du­res in re­gu­la­ted sec­tors such as the life sci­en­ces in­dus­try. It op­ti­mi­zes the en­ti­re life cy­cle of SOPs, from crea­ti­on and ap­pr­oval to au­dit-com­pli­ant ar­chi­ving. This tech­no­lo­gy keeps do­cu­men­ta­ti­on up to date and com­pli­ant with re­gu­la­to­ry re­qui­re­ments, which in­crea­ses ef­fi­ci­en­cy and re­du­ces the risk of non-com­pli­ance. The di­gi­tal trans­for­ma­ti­on sup­ports trans­pa­ren­cy and tracea­bi­li­ty of pro­ces­ses for suc­cessful ope­ra­tio­nal management.

To crea­te ef­fec­ti­ve stan­dard ope­ra­ting pro­ce­du­res (SOPs), re­fe­rence books and on­line cour­ses can be va­luable re­sour­ces. The­se of­fer theo­re­ti­cal know­ledge and best prac­ti­ces. In ad­di­ti­on, trade jour­nals pro­vi­de the la­test fin­dings and in­no­va­tions in qua­li­ty ma­nage­ment to en­su­re that SOPs meet the la­test re­qui­re­ments. By using the­se re­sour­ces, you streng­then your role as a qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve and con­tri­bu­te to ef­fi­ci­en­cy and trans­pa­ren­cy in your company.

The crea­ti­on and im­ple­men­ta­ti­on of Stan­dard Ope­ra­ting Pro­ce­du­res (SOPs) is cru­cial for an ef­fec­ti­ve qua­li­ty ma­nage­ment sys­tem. SOPs de­fi­ne pre­cis­e­ly how tasks should be car­ri­ed out sys­te­ma­ti­cal­ly and uni­form­ly in or­der to achie­ve con­sis­tent re­sults. The use of SOPs mi­ni­mi­zes er­rors, in­crea­ses ef­fi­ci­en­cy and en­su­res uni­form qua­li­ty. They are es­sen­ti­al for com­pli­ance with re­gu­la­to­ry re­qui­re­ments and pro­mo­te a cul­tu­re of con­ti­nuous im­pro­ve­ment in companies.

Stan­dard ope­ra­ting pro­ce­du­res (SOPs) are es­sen­ti­al in qua­li­ty ma­nage­ment in or­der to en­su­re uni­form stan­dards and com­ply with le­gal re­qui­re­ments in the life sci­ence in­dus­try. SOPs pro­vi­de clear in­s­truc­tions for qua­li­ty assu­rance in pro­duc­tion, mi­ni­mi­ze de­via­ti­ons and streng­then con­fi­dence in pro­duct qua­li­ty. SOPs give em­ployees the know­ledge and skills they need to re­du­ce er­rors and make pro­ces­ses more efficient.

To wri­te an SOP cor­rect­ly, choo­se a clear and struc­tu­red ap­proach. A well-for­mu­la­ted SOP ser­ves to do­cu­ment pro­ces­ses, ef­fi­ci­en­cy and com­pli­ance. Start with a pre­cise ex­pl­ana­ti­on of the SOP and cle­ar­ly de­fi­ne its ob­jec­ti­ve. Or­ga­ni­ze the do­cu­ment into com­pre­hen­si­ble steps. Clear and pre­cise wor­ding is es­sen­ti­al to avo­id mi­sun­derstan­dings. An SOP tem­p­la­te can be hel­pful in or­der to in­sert im­portant ele­ments con­sis­t­ent­ly. Pay at­ten­ti­on to re­spon­si­bi­li­ties, re­sour­ces and spe­ci­fic requirements.

The re­gu­lar re­view and ad­apt­a­ti­on of stan­dard ope­ra­ting pro­ce­du­res (SOPs) is es­sen­ti­al in qua­li­ty ma­nage­ment in the life sci­ence in­dus­try. Up­dates en­su­re com­pli­ance with cur­rent re­qui­re­ments and best prac­ti­ces, sup­port the in­tro­duc­tion of new in­for­ma­ti­on and tech­no­lo­gies and en­su­re com­pli­ance with FDA 21 CFR Part 11 and EU GMP. In­ter­nal feed­back from qua­li­ty ma­nage­ment, pro­duc­tion and IT is cru­cial for prac­ti­ca­ble SOPs. Con­ti­nuous up­dating streng­thens qua­li­ty, trust and trans­pa­ren­cy wi­thin the company.

A stan­dard ope­ra­ting pro­ce­du­re (SOP) com­pri­ses a lar­ge num­ber of tasks ai­med at stan­dar­di­zing pro­ces­ses and pro­ce­du­res wi­thin a com­pa­ny. Ty­pi­cal tasks in­clude the de­tail­ed do­cu­men­ta­ti­on of work pro­ces­ses, safe­ty pro­to­cols and qua­li­ty assu­rance me­a­su­res. In or­der to pro­cess the­se tasks ef­fi­ci­ent­ly, it is ad­vi­sa­ble to de­fi­ne cle­ar­ly de­fi­ned steps and re­spon­si­bi­li­ties in the SOP. A well-struc­tu­red SOP fa­ci­li­ta­tes the pro­ces­sing of com­plex do­cu­men­ta­ti­on by pro­vi­ding clear in­s­truc­tions for hand­ling new pro­ce­du­res and im­ple­men­ting them in exis­ting processes.

A stan­dard ope­ra­ting pro­ce­du­re (SOP) plays a cru­cial role in qua­li­ty assu­rance, espe­ci­al­ly when in­tro­du­cing new pro­ce­du­res. The de­tail­ed do­cu­men­ta­ti­on of the new pro­ces­ses and steps in the SOP en­su­res that all em­ployees work on the same tasks in a con­sis­tent man­ner. This mi­ni­mi­zes er­rors and en­su­res that the new pro­ce­du­res are car­ri­ed out in ac­cordance with the de­fi­ned stan­dards. The SOP ser­ves as a re­fe­rence do­cu­ment and pro­vi­des clear in­s­truc­tions that sup­port the ef­fi­ci­ent im­ple­men­ta­ti­on and mo­ni­to­ring of new pro­cess steps, ther­eby con­tri­bu­ting to over­all ef­fi­ci­en­cy and qua­li­ty assu­rance wi­thin the company.

Practical example of SOP management in the company:

Our com­pa­ny ex­am­p­le is Mus­ter­mann GmbH. The last in­ter­nal au­dit in the pro­duc­tion de­part­ment re­sul­ted in ne­ces­sa­ry ch­an­ges and im­pro­ve­ments in the main­ten­an­ce pro­cess. In this case Er­win Er­stel­ler is re­spon­si­ble for this pro­cess. The company’s do­cu­ment con­trol sys­tem spe­ci­fies exact­ly which steps the do­cu­ment must go th­rough be­fo­re the new ver­si­on is pu­blished. The de­scrip­ti­on of the main­ten­an­ce pro­cess is de­fi­ned as a 4‑level do­cu­ment and the­r­e­fo­re goes th­rough the fol­lo­wing steps:

1. Create/revise     2. Re­view     3. Ap­pro­ve     4. Re­lease     5. Schools     6. Set­ting effective

(Click on the pro­cess steps be­low for more information)

Dokumentenumlauf dls | eQMS sop management
SOP ma­nage­ment example

Our com­pa­ny ex­am­p­le is Mus­ter­mann GmbH. The last in­ter­nal au­dit in the pro­duc­tion de­part­ment re­sul­ted in ne­ces­sa­ry ch­an­ges and im­pro­ve­ments in the main­ten­an­ce pro­cess. In this case Er­win Er­stel­ler is re­spon­si­ble for this pro­cess. The company’s do­cu­ment con­trol sys­tem spe­ci­fies exact­ly which steps the do­cu­ment must go th­rough be­fo­re the new ver­si­on is pu­blished. The de­scrip­ti­on of the main­ten­an­ce pro­cess is de­fi­ned as a 4‑level do­cu­ment and the­r­e­fo­re goes th­rough the fol­lo­wing steps:

  1. Create/revise
  2. Re­view
  3. Ap­pro­ve
  4. Re­lease
  5. Train
  6. En­act
1. Crea­te | Revise

Er­win Er­stel­ler crea­tes a new do­cu­ment ba­sed on a tem­p­la­te or an exis­ting do­cu­ment, or crea­tes a new ver­si­on of an exis­ting SOP, for ex­am­p­le. Of cour­se, he can also in­vol­ve se­ve­ral edi­tors in the crea­ti­on pro­cess. Af­ter crea­ting or mo­di­fy­ing the do­cu­ment, Er­win Er­stel­ler sets the do­cu­ment cir­cu­la­ti­on (re­view, ap­pr­oval and re­lease) and fi­nis­hes the editing. Using the work­flow sys­tem, the do­cu­ment is au­to­ma­ti­cal­ly for­ward­ed to the re­spon­si­ble re­view­er (one or more), who re­cei­ves a cor­re­spon­ding task.

2. Re­view

In this step, the con­tent check ta­kes place. Paul Prü­fer, the re­spon­si­ble re­view­er of the do­cu­ment, opens his task and stu­dies the con­tents of the do­cu­ment sent to him. He has the pos­si­bi­li­ty to ap­pro­ve the do­cu­ment and thus pass it on to the next stee­ring step or to re­ject the do­cu­ment, to add comments/comments/wishes for ch­an­ges and to send it back to Er­win Er­stel­ler. In ad­di­ti­on, en­qui­ries can be pla­ced about the do­cu­ment. If the do­cu­ment is ap­pro­ved, it will be for­ward­ed to Adam Ap­pro­ver.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS Document circulation: Review step

3. Ap­pro­ve

In the cour­se of the ap­pr­oval Adam Ap­pro­ver has the same options/functions as Vic­tor Ve­ri­fier. If he dis­co­vers for­mal er­rors or if ge­ne­ral­ly ne­ces­sa­ry cor­rec­tions need to be made, he can add his comm­ents and send the do­cu­ment back to the crea­tor. If Adam Ap­pro­ver ap­pro­ves the do­cu­ment, it is sent to Ri­chard Re­leaser for release.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS document circulation: Step Approval

4. Re­lease
The de­part­ment head Fried­rich Frei­ge­ber is re­spon­si­ble for the re­lease of the do­cu­ment or the new re­vi­si­on. If the­re are no ob­jec­tions, he con­firms the re­lease by me­ans of a di­gi­tal si­gna­tu­re and com­ple­tes the work­flow for the do­cu­ment as such. In the re­lease, Fried­rich Frei­ge­ber can de­fi­ne va­li­di­ty dates such as va­lid from, va­lid un­til (pe­ri­odic re­view) with re­fe­rence to the do­cu­ment and, among other things, de­fi­ne trai­ning coordinators. 
Learn how the pro­cess can be im­ple­men­ted digitally: dls | eQMS Document circulation: Step Release
5. Train

With the re­lease of a new do­cu­ment or re­vi­si­on, a trai­ning re­qui­re­ment is ge­ne­ra­ted. All em­ployees who need to know this do­cu­ment will re­cei­ve a trai­ning task wi­thin the sys­tem. The au­to­ma­ti­cal­ly for­med qua­li­fi­ca­ti­on ma­trix shows you at any time at the push of a but­ton which trai­ning le­vel your em­ployees have. In the area of trai­ning, a va­rie­ty of trai­ning ty­pes (re­a­ding trai­ning, re­a­ding trai­ning with elec­tro­nic exam, e‑learning, face-to-face trai­ning, etc.) are available.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS document circulation: train step

6. En­act

Af­ter the de­fi­ned trai­ning pha­se, the do­cu­ment au­to­ma­ti­cal­ly ta­kes ef­fect (un­less con­fi­gu­red other­wi­se). The do­cu­ment re­mains va­lid un­til a new ver­si­on is crea­ted and the do­cu­ment cir­cu­la­ti­on starts again. Short­ly be­fo­re rea­ching (time pe­ri­od in­di­vi­du­al­ly sel­ec­ta­ble) the spe­ci­fied va­li­di­ty date of the do­cu­ment, a task for pe­ri­odic re­view is au­to­ma­ti­cal­ly sent, usual­ly to the crea­tor. The re­ci­pi­ent can, if no ch­an­ges are ne­ces­sa­ry, ex­tend the run­time of the do­cu­ment by an­o­ther cy­cle. If ch­an­ges are ne­ces­sa­ry, a new ver­si­on is created.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS signature circulation: Signature circulation

Dokumentenumlauf dls | eQMS sop management

Our com­pa­ny ex­am­p­le is Mus­ter­mann GmbH. The last in­ter­nal au­dit in the pro­duc­tion de­part­ment re­sul­ted in ne­ces­sa­ry ch­an­ges and im­pro­ve­ments in the main­ten­an­ce pro­cess. In this case Er­win Er­stel­ler is re­spon­si­ble for this pro­cess. The company’s do­cu­ment con­trol sys­tem spe­ci­fies exact­ly which steps the do­cu­ment must go th­rough be­fo­re the new ver­si­on is pu­blished. The de­scrip­ti­on of the main­ten­an­ce pro­cess is de­fi­ned as a 4‑level do­cu­ment and the­r­e­fo­re goes th­rough the fol­lo­wing steps:

  1. Create/revise
  2. Re­view
  3. Ap­pro­ve
  4. Re­lease
  5. Train
  6. En­act

Er­win Er­stel­ler crea­tes a new do­cu­ment ba­sed on a tem­p­la­te or an exis­ting do­cu­ment, or crea­tes a new ver­si­on of an exis­ting SOP, for ex­am­p­le. Of cour­se, he can also in­vol­ve se­ve­ral edi­tors in the crea­ti­on pro­cess. Af­ter crea­ting or mo­di­fy­ing the do­cu­ment, Er­win Er­stel­ler sets the do­cu­ment cir­cu­la­ti­on (re­view, ap­pr­oval and re­lease) and fi­nis­hes the editing. Using the work­flow sys­tem, the do­cu­ment is au­to­ma­ti­cal­ly for­ward­ed to the re­spon­si­ble re­view­er (one or more), who re­cei­ves a cor­re­spon­ding task.

In this step, the con­tent check ta­kes place. Paul Prü­fer, the re­spon­si­ble re­view­er of the do­cu­ment, opens his task and stu­dies the con­tents of the do­cu­ment sent to him. He has the pos­si­bi­li­ty to ap­pro­ve the do­cu­ment and thus pass it on to the next stee­ring step or to re­ject the do­cu­ment, to add comments/comments/wishes for ch­an­ges and to send it back to Er­win Er­stel­ler. In ad­di­ti­on, en­qui­ries can be pla­ced about the do­cu­ment. If the do­cu­ment is ap­pro­ved it will be for­ward­ed to Adam Ap­pro­ver.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS Document circulation: Review step

In the cour­se of the ap­pr­oval Ge­rold Ge­neh­mi­ger has the same options/functions as Paul Prü­fer. If he dis­co­vers for­mal er­rors or ge­ne­ral­ly ne­ces­sa­ry cor­rec­tions need to be made, he can add his comm­ents and send the do­cu­ment back to the crea­tor. If Adam Ap­pro­ver ap­pro­ves the do­cu­ment it will be sent to Ri­chard Re­leaser to be released.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS document circulation: Step Approval

The de­part­ment head Fried­rich Frei­ge­ber is re­spon­si­ble for the re­lease of the do­cu­ment or the new re­vi­si­on. If the­re are no ob­jec­tions, he con­firms the re­lease by me­ans of a di­gi­tal si­gna­tu­re and com­ple­tes the work­flow for the do­cu­ment as such. In the re­lease, Fried­rich Frei­ge­ber can de­fi­ne va­li­di­ty dates such as va­lid from, va­lid un­til (pe­ri­odic re­view) with re­fe­rence to the do­cu­ment and, among other things, de­fi­ne trai­ning coordinators.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS Document circulation: Step Release

With the re­lease of a new do­cu­ment or re­vi­si­on, a trai­ning re­qui­re­ment is ge­ne­ra­ted. All em­ployees who need to know this do­cu­ment will re­cei­ve a trai­ning task wi­thin the sys­tem. The au­to­ma­ti­cal­ly for­med qua­li­fi­ca­ti­on ma­trix shows you at any time at the push of a but­ton which trai­ning le­vel your em­ployees have. In the area of trai­ning, a va­rie­ty of trai­ning ty­pes (re­a­ding trai­ning, re­a­ding trai­ning with elec­tro­nic exam, e‑learning, face-to-face trai­ning, etc.) are available.


Learn how the pro­cess can be im­ple­men­ted digitally:

Af­ter the de­fi­ned trai­ning pha­se, the do­cu­ment au­to­ma­ti­cal­ly ta­kes ef­fect (un­less con­fi­gu­red other­wi­se). The do­cu­ment re­mains va­lid un­til a new ver­si­on is crea­ted and the do­cu­ment cir­cu­la­ti­on starts again. Short­ly be­fo­re rea­ching (time pe­ri­od in­di­vi­du­al­ly sel­ec­ta­ble) the spe­ci­fied va­li­di­ty date of the do­cu­ment, a task for pe­ri­odic re­view is au­to­ma­ti­cal­ly sent, usual­ly to the crea­tor. The re­ci­pi­ent can, if no ch­an­ges are ne­ces­sa­ry, ex­tend the run­time of the do­cu­ment by an­o­ther cy­cle. If ch­an­ges are ne­ces­sa­ry, a new ver­si­on is created.


Learn how the pro­cess can be im­ple­men­ted digitally:

dls | eQMS document circulation: Document circulation

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Corrective action

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