Applying Process-based Analytics to Audit Results for Process Management and Improvement
Applying Process-based Analytics to Audit Results for ProcessManagement and ImprovementJohn G. Surak, PhD Jeffery L. CawleySurak and Associates Northwest AnalyticsClemson, SC Portland, OR
Operational audits and inspections play a critical role inassuring the effectiveness of food safety system (Table 1).To achieve maximum effectiveness of these activities,key process indicators should be identified and plotted oncontrol charts. The control charts can then be assessed fortrends, so actions can be taken before a food safetyincident occurs. Preoperational Audit Facility Audit Pest Control Audit Microbial Environmental Monitoring Audit Table 1 – Examples of Operational Inspections and Audits
The GFSI benchmarked audit schemes require that foodprocessors conduct an internal audit. The internal auditshould determine the conformance of the Food SafetyManagement System (FSMS) to plan. It is used to answerthe following questions: • Is the FSMS implemented? • Is the FSMS effective? • Is the FSMS efficient? • Is the FSMS sustainable? • Is the FSMS updated?The internal audit is not a substitute for the other audits.The primary focus of the operational inspections andaudits is to determine if the food safety activities are beingcarried out. The primary focus of the internal audit shouldto determine if the FSMS is working as planned.
This will cause a shift in the types of audits that areconducted from a checklist approach to a processapproach.For example, a checklist for a preoperational audit may askthe question, “Are the floors clean?” The auditor mayobserve that a floor is not properly clean. Using theprocess audit concept, the auditor may ask additionalquestions that focus on gathering information on why thefloor is not clean.In addition, the auditor may be also responsible for takingmicrobiological environmental samples and reporting theresults to the manager responsible for cleaning andsanitizing. Individual results of the weekly microbialenvironmental monitoring audit, reported as CFUs/inch²,will summarize the effectiveness of the cleaning programfor that week.
The auditor should also plot the microbial data over aperiod of time to determine if there are any trends inthe cleaning and sanitizing program.
Control charts can be used to display the sanitationdata. Examples of these plots are shown in Figures 1and 2. Figure 1 shows the plot of environmentalsamples over a period of a half of year. The sampleswere taken after cleaning and before sanitization.The graph shows a number of signals as indicated bythe red diamonds. These signals show that there wasa change in the cleaning process.The auditor responsible for taking and analyzing thedata should provide feedback that problems wereobserved in the effectiveness of the cleaning programso that the cleaning and sanitizing program can beimproved.
The function of the internal audit is to verify theeffectiveness of the FSMS or determine that theorganization is functioning according to plan. In theprevious example, the internal audit primary focus is todetermine if the verification system for cleaning andsanitizing is properly working.For example, during the planning part of an internalaudit that focuses on cleaning and sanitizing, the auditorcan review records which include control charts. Theinternal auditor may conduct further analysis of themicrobial data.
Figure 2 show a second control chart of the samemicrobial data. In this chart, the control limits werecalculated by each quarter. In addition to the signals thatwere observed in Figure 1, the second control chartindicates that there was an increase in the variation ofmicrobial levels between the first quarter and the secondquarter.As part of this audit, the auditor should investigate whatwas done with the original environmental samplinginformation. Did the auditor who was responsible fortaking the environmental samples provide effectivefeedback to plant management responsible for cleaningand sanitization? Did the plant determine why thecleaning process deteriorated? If a root cause wasidentified, was this knowledge used to improve thecleaning and sanitizing process?
Operational Operational Verification of Internal Management CertificationFood Safety Food Safety Audits Review Audits Activities Activities Figure 3: Linkage between operational activities and the Food Safety Certification Audit
Finally the internal audit reports and findings feed intomanagement review, to assess the effectiveness of theFSMS, and develop objectives and business plans toupdate and improve the FSMS. Figure 3 shows thelinkage of food safety activities linkage to certificationaudits.The proper linkage and operation of the components ofthe FSMS allows for successful certification audits andgives confidence to Senior Management and otherstakeholders that the organization has a robust foodsafety management system.Contact information:John G. Surak Jeffery L. CawleyPrincipal Vice President Industry LeadershipSurak and Associates Northwest AnalyticsClemson, SC Portland, OR864-506-2190 firstname.lastname@example.org@yahoo.com 503-224-7727