Webinar audit time calculation 22 June 2015
Mission FSSC 22000 To be the world s leading, independent, GFSI recognized, ISO based food safety and quality management system for the entire food supply chain.
Auditor Qualification and Competence The on-site audit time is essential for the integrity of the FSSC 22000 certification scheme The CB is responsible for the correct calculation of the audit time for the FSSC audit
Enter Manufactures Auditor qualification and competence FSSC scheme document Part II, Appendix II A1, section 1, section 5 Basic elements: Basic audit time as stipulated in ISO 22003:2007, clause 9.1.4 and Annex B 0,5 day additional FSSC audit time when the company has less than 250 employees and less than 5 production lines and less than 3 HACCP studies 1,0 day additional FSSC audit time if one of the above conditions are not met
Enter Manufactures Reference documents ISO 22003:2007, clause 9.1.4; ISO 22003:2007, Annex B; FSSC guidance document Audit time calculation tool. IAF Mandatory Documents Only for FSSC Q-Module IAF MD 5 IAF MD 11
Starting point One audit day is 8 hours It is not allowed to reduce the number of audit days by programming longer hours per working day Travelling time is not included Preparation time is not included
FSSC audit time calculation 1. FSSC audit time calculation (basic) 2. Organizations with multiple locations 3. ISO 22000 transition audit 4. FSSC 22000-Q audit 5. Reasons for increasing audit duration 6. Reporting time 7. Additional 8. Mistakes seen during FSSC desk reviews 9. Three year certification cycle Time line
1a. FSSC audit time calculation Initial certification audit Ts = (D + H + MS + FTE) FSSC audit time: Ts + additional audit time The total FSSC audit time is divided over the stage 1 and stage 2 audit. D = basic on-site audit time H = additional HACCP studies MS = absence of relevant MS FTE = number of employees
1b. FSSC audit time calculation First and second surveillance audit Ts = 1/3 x (D + H + MS + FTE) FSSC audit time: Ts + additional audit time D = basic on-site audit time H = additional HACCP studies MS = absence of relevant MS FTE = number of employees
1c. FSSC audit time calculation Re-certification audit Ts = 2/3 x (D + H + MS + FTE) FSSC audit time: Ts + additional audit time D = basic on-site audit time H = additional HACCP studies MS = absence of relevant MS FTE = number of employees
Keep in mind that The calculated audit time is the minimum required audit time. CB may add extra on-site audit time if necessary. The 50% audit time reduction for additional sites is not applicable for FSSC 22000. Each site requires its own audit. MS. The MS are existing ISO 22000 and ISO 9001 certificates.
2a. Organizations with multiple locations Certain functions controlled by the Head Office The minimum on-site audit time to audit the functions at the Head Office is 0,5 days No extra time is added when the (lead) auditor decides that it is acceptable that a representative of the Head Office is present during the manufacturing site audit
2b1. Organizations with multiple locations Split-process 1. Only 2 locations are involved the primary manufacturing site and the secondary for defined process steps. 2. There is clearly one process involved, resulting in a finished product, which is within scheme scope. 3. The audit must clearly include all relevant requirements at both the primary and secondary locations, and allow investigations and outcomes to be identified as location specific. 4. The secondary site carries out the described process steps solely for the primary site and does not service any other sites or customers. 5. The locations are under the same overall food safety management system, and part of the same legal entity. 6. The certificate must show the address of both sites, but must clearly identify which is the primary site.
2b2. Organizations with multiple locations Split-process The minimum on-site audit time shall be 0,5 days on-site at the secondary location when the location has less than 250 employees and less than 3 production lines and 1 HACCP study The minimum on-site audit time shall be 1,0 days on-site at the secondary location when the location has more than 250 employees or more than 3 production lines or more than 1 HACCP study
3a. ISO 22000 transition audit The transition audit from ISO 22000 to FSSC is a combined stage 1 and stage 2 audit It is a kind of certification audit The best comparison is a re-certification audit. The transition audit is treated as a recertification audit to supply the auditor with enough time to perform the (certification) audit
3b. ISO 22000 Transition audit Transition from ISO 22000 to FSSC 22000 Combined with scheduled surveillance audit Combined with scheduled re-certification audit Ts = 2/3 x (D + H + MS + FTE). A minimum of 0,5 days on-site Transition audit time: Ts + additional FSSC audit time
4. FSSC 22000 Q-Module Integrated FSSC 22000 and ISO 9001 audit Use IAF MD 5 to calculate the basic ISO 9001 audit time The FSSC audit time is Ts plus the additional FSSC audit time Use IAF MD 11 to calculate the audit time of the integrated audit using the basic ISO 9001 audit time and the FSSC audit time
5. Reasons for increasing audit duration The audit time calculated using the audit time calculation tool is the minimum on-site audit time in man-days Complicated logistics Staff speaking more than one language Very large site or number of personnel High degree of regulation System covers highly complex processes or relatively high number of unique activities Temporary seasonal activities
6. Reporting time Additional FSSC 22000 time Part of the additional time is dedicated to the reporting Ts does not include time for writing the audit report Sufficient time must be allocated to the auditor to write the audit report. The (minimum) time for writing the total FSSC report is 0,5 to 1,0 days
7. Additional The audit time (audit duration) must be shown in the audit report The audit duration must be supported by an audit plan or audit program The auditor may decide to extend the audit because time is needed for the audit or to assess audit trails as they occur during the audit Dedicated audit time calculation for very small companies. Contact FSSC secretariat
8. Common mistakes Desk Review Results The application of audit time reduction Application of 50% audit time reduction for additional sites Addition of the required additional FSSC audit time is forgotten The application of MS in the equation No audit time calculation provided for review Audit time is not shown in report Audit program (audit plan) is not submitted for review 3-year certification cycle targets
9. Certification cycle time line 3 year certification cycle First year Second year Third year The cycle starts with the issue date of the certificate FSSC 22000, Part I, section Surveillance ISO 17021:2011, clause 9.1.1.2 First surveillance audit First surveillance audit within 12 months after the last day of the stage 2 audit ISO 17021:2011, clause 9.3.2.2 Second surveillance audit Re-certification audit The certificate has to reissued before the end of the 3 year certification cycle FSSC 22000, Part I, section Re-certification ISO 17021:2011, clause 9.1.1.2
Take aways The auditor is out there doing his job We all depend on the professional judgement of the auditor The auditor needs sufficient time to perform the audit and to draft the audit report
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