SOPs:Whathappenedtosaywhatyoudoanddowhat yousay?

Documentcontrolisstilloneofthemostcommonsareasof nonconformanceinauditsandinspections.Analysisofthese nonconformancesidentifiesthefailureismostoftentheresult ofnoncompliancetotheprocedure,ratherthan noncompliancetotheregulationorstandard.Letslookat someofthepracticesinindustrythatcontributetothesetypes ofissues. Sometimes,SOPsarewrittenveryexplicitlyinanattemptto errorproofthemfortheemployee.Asemployeesbecome familiarwiththeprocess,theydontalwayshavethewritten documentopeninfrontofthemwhenperformingthespecific process.Thisopensopportunitiestoomitstepsorsmalldetails thatwereincludedintheprocedure,butarenottrulycriticalto thecompletionoftheprocess. Clarityoftheprocedureisadelicatebalanceintheamountand typeofdetailprovidedintheinstructions.Therearesome processeswhereexplicitdetailisnecessarytoassurethe qualityoftheendproduct.Hereareacoupleofexamples: Mix30minutesat37degreesC.Is30minutescritical?What happensifitmixes35minutes?Or25minutes?Whatifthe

temperaturegoesto38degrees? Productmustsitinstagingforupto48hourscanthe productbereleasedtothemarketplaceifitsits50hours?72 hours? AdjustpHto7.2whatistheimpactontheproductifyou overshootthepHadjustment?Canyouadjustfurtherwithout ruiningtheproduct? Turnscrew2timeswhathappensifyouturnthescrew3 times?Oronly2times? Whiletheseexamplesmayseemextreme,theydemonstrate theimportanceofclarityintheSOP.Productandprocess validationshoulddeterminethecriticalityandimpactof specifics,suchastheexamplesontheendproduct.Tolerances shouldbeestablished(37+/2;stage4872hours)where appropriatetoallowadequateflexibilityandpreventpotential manufacturingdeviationsandnonconformances.Ifa measurementoractionisCriticalToQuality(CTQ)fortheend productorprocess,thisshouldbedocumentedintheSOP. TherearemanyapproachesyoucantakewhenwritingSOPsfor usability.Remember,theauditorislookingforcompliancefrom twoperspectives: Toregulationsorstandards Toyourownprocesses

Suggestions for success: Keep it simple. Make it easy for the employee to be compliant Too much detail (not critical to the quality of the end product) creates potential for error and nonconformance Make it clear if steps must be performed in sequence Consider the use of flow charts over lots of words Validate the SOP