Handbook of Hygiene Control in the Food Industry

3. Incidentmanagement. Whilethis termis usually reserved for incidents that
   maylead to publicconsequences (such as product withdrawals and recalls),
   withinthis context we willuse it to refer to mechanisms to address
   situations wherenormalprocedures havefailed and the processin question
   is `out of control'.


4. Audit. For our purposes, the definitionof an audit systemmaynowbe
   expanded a bit. Whileaudits mayconcentrate on one or moreof the above
   levels(e.g.lookat establishedcontrolmechanisms but neveropena pump
   to assess basic hygienic design or the effectiveness of a standard
   maintenance/sanitationprogramme),it is clearthat the definitionshould
   coverall relevant aspects:a critical assessmentof all the abovelevels
   againstall considerationsthat are relevantfor the fundamental purpose of
   the system(as detailedat the beginningof this section). For most audits
   carriedout today, this is much too widebut we will needboththe depth in
   termsof levels and the breadth in terms of all relevant considerations'for our currentauditing for hygiene improvement'purposes.

40.4 Purposes of an auditingsystem

For the designof an auditsystem, we maydistinguishfourmainpurposes:

1. Compliance, verification. Fundamentallythis type of auditassessesan
   entiremanagementsystemaccordingto the above-mentioned `basicdesign'
   perspective: haveall prescribedelements beenput in placeand are they
   beingoperatedaccording to the requirementsof the standard? For this
   purposewe will needpre-agreed standards that are sufficientlyprecise and
   detailedto allowclear yes/no(or gradedin termsof major/minor) scores
   regardingcompliance. Auditors will haveto knowthe standard thoroughly
   (but no more thanthat)and,because of the potentialconsequences for the
   auditee of non-compliance, need to be seen as strictly impartial and
   independent. Assumingthat the standardis relevantand sufficient(the
   never-endingstreamof new standards seemsto indicatethat this remains a
   challenge) and that the facility in question does not yet meet all
   requirements, a complianceauditmay lead to improvement.That,however,
   is not the mainpurpose of this typeof auditand improvement potentialis
   anywaylimitedto whatis foreseenby the standarditself.


2. Effectiveness,capability to performto specifications,validation. Thistype
   of audit normally builds on the compliance perspective, extending the
   question whether everythingis in placeaccording to the standard to: doesit workas intended?'. The focusis shifted frombasicdesign' to control'. An intimateknowledgeofthe standard' is no longersufficient,the auditor will
   haveto be able to makean informed decision regardingthe effectivenessof
   the control system, basedon quantitative historical information.Where
   processcapabilityissuesare found,some indication of the rootcauseis

688 Handbookof hygiene controlin the foodindustry