processparameters,packaging,storage, distribution, and consumeruse. The list
is not exhaustive, but is basedon experience of situations wherefailureto take
such changes intoaccount has resulted in serious human or commercial
consequencesor both.
21.6 Manufacturingand operatingprocedures
The operationsand processes usedin manufactureshould,with the premises,
equipment, materials, personnel and services provided, be capable of
consistentlyyieldingfinishedproducts that conformto theirspecificationsand
are suitablyprotectedagainst contaminationor deterioration.Definitionand
documentationof manufacturingprocedures, including associated activitiesand
precautions,are necessaryto ensurethat all concernedunderstandwhat has to be
done,how it is to be done and who is responsible, and avoidanceof mistakesthat
couldcompromise safety or quality. For eachproduct, this should be providedin
comprehensivemastermanufacturinginstructions(MMI).
Beforethe introductionof MMIfor a product, trialsshouldbe carried out to
establish whether the formulation,methodsand proceduresspecifiedthereinare
suitablefor factory production,and are capable of consistentlyyielding products
withinthe finishedproductspecification.If necessary,amendmentsand further
trialsshouldbe made until theseconditionsare satisfied. Similar evaluation
shouldbe carriedout in connection withany significantproposed changeof raw
material, plantor method;and should be carried out periodically,to checkthat
the MMIare being followed,that they still represent an effectiveand acceptable
wayof achieving the specifiedproduct and that they are stillcapableof
consistentlydoingso.
Thereshouldbe providedpremises,equipment, materials,suitablytrained
personnel, services,informationand documentation,in eachcaseof appropriate
quantityand quality, to enable the requisitequantityand qualityof finished
products to be produced. Production shouldbe carriedout in full compliance
withthe MMI,fromwhichno departure should be permittedexceptby written
instructionsfromthe managers responsiblerespectivelyfor production and for
foodcontrol, indicating the natureand duration of the departure,and agreedand
signedby them.
Incentive bonus schemes for production operators can create potential
hazardsand, viewedfromthe standpointof safety and quality, are best avoided.
If, however, the provision of an incentivebonusschemeis companypolicy,it
shouldbe so designedas to discourage operators fromtakingunauthorised
short-cuts', for example by buildinginto the formula for bonuscalculationa quality factor' and/orpenalty for observeddeviation.In general, preventionof
unauthorisedshort-cuts is primarilya taskfor managementand supervision.
Whereoperatorshaveideasfor processsimplificationor improvement,they
shouldbe encouraged to raisethem(for example throughsuggestionsschemes)
so that theymaybe properly evaluated.
Goodmanufacturing practice(GMP)in the foodindustry 331