Standard Operating Procedure (SOP)

Definition of the term (“What is an 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 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)

Why are SOPs im­portant in com­pa­nies?
SOPs are im­portant to en­su­re con­sis­tent qua­li­ty, ef­fi­ci­en­cy and safe­ty in organizations.

Can I crea­te SOPs for each busi­ness area?
Yes, SOPs can be crea­ted in al­most any in­dus­try and for a wide va­rie­ty of processes.

How of­ten should I up­date my SOPs?
SOPs should be re­view­ed re­gu­lar­ly and up­dated as nee­ded to en­su­re they meet cur­rent requirements.

Is the­re soft­ware that is hel­pful in crea­ting SOPs?
Yes, the­re are de­di­ca­ted soft­ware ap­pli­ca­ti­ons that fa­ci­li­ta­te the crea­ti­on and ma­nage­ment of SOPs. One re­com­men­ded soft­ware is Do­cu­ment Con­trol from Di­gi­tal Life Sciences.

Whe­re can I find more re­sour­ces for crea­ting SOPs?
You can use books, on­line cour­ses, and pro­fes­sio­nal jour­nals to learn more about crea­ting SOPs.

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. Check     3. Ap­pro­ve     4. Re­lease     5. Trai­ning     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: 
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 document circulation: Document 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 Adam Ap­pro­ver has the same options/functions as Vic­tor Ve­ri­fier. 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

Share now!

Subscribe to the newsletter

You want to stay up to date? Then subscribe to our newsletter.

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