Tajuk :

MANUAL PROSEDUR KERJA SKIM PENSIJILAN HACCP DAN GMP KEMENTERIAN KESIHATAN MALAYSIA

No. Dokumen : BKKM-MPK-AUDIT

Keluaran : 01 Pindaan : 00 Tarikh Kuatkuasa : 01 Januari 2015

LAMPIRAN 3

AUDIT-5/2014

FOOD SAFETY AND QUALITY DIVISION MINISTRY OF HEALTH MALAYSIA

GUIDELINE FOR CONDUCTING

ONSITE AUDIT

1. ENTRY MEETING: 1.1. Opening meeting (Chaired by the Lead Auditor) 1.2. Introduce audit team members 1.3. Request auditee to introduce themselves 1.4. Circulate attendance list. 1.5. Brief on the overall audit plan and itinerary. 1.6. Explain the scope and purpose of the audit, how it will be conducted. 1.7. Confirm the plan and accompanying personal for the on-site visit. 1.8. The company’s management should in brief, inform the auditor(s) about the

latest overview of HACCP/GMP Implementation in the premise especially if there are any changes/modification made to the HACCP/GMP system.

1.9. Describe the method of non-conformance reporting and define the CAR Categories and their implication.

1.10. Remind the auditee regarding the updated version of HACCP Manual, GMP Manual, records and logbooks should be available for review.

1.11. Remind the auditee the times indicated are subjected to adjustment forward or backward depending on the progress of the assessment.

1.12. Remind the auditee to bring the camera and other equipment during onsite audit.

1.13. Confirm working hours, lunch/tea break arrangements and interim meetings.

Tajuk :

MANUAL PROSEDUR KERJA SKIM PENSIJILAN HACCP DAN GMP KEMENTERIAN KESIHATAN MALAYSIA

No. Dokumen : BKKM-MPK-AUDIT

Keluaran : 01 Pindaan : 00 Tarikh Kuatkuasa : 01 Januari 2015

2. AUDIT PROCESS: 2.1. Discussion regarding the work segregation between auditor(s). 2.2. Compliance audit shall cover the aspect below :

2.2.1. Plant Visit : 2.2.1.1. Verify process flow diagram onsite 2.2.1.2. Conduct observation on process, procedures and premise

2.2.2. Document audit : 2.2.2.1. Clarification of adequacy document comments 2.2.2.2. On-site document/record review 2.2.2.3. Verification of HACCP/GMP Program, monitoring and

checking records 2.3. Surveillance/Renewal audit shall cover the aspect below :

2.3.1. Record view: 2.3.1.1. Review of records on the pre-requisite program 2.3.1.2. Verify that food safety objective(s) are being met 2.3.1.3. Review of records relating to CCP’s/GMP including review of

records on monitoring, corrective actions and verification. 2.3.1.4. Review of modifications to the HACCP/GMP Plan such as :

2.3.1.4.1. Changes in raw materials 2.3.1.4.2. Changes in processing parameter or product

information 2.3.1.4.3. Installation of an line equipment of modification 2.3.1.4.4. Changes in packaging or final product handling 2.3.1.4.5. Label changes regarding preparation of product. 2.3.1.4.6. Changes of intended consumer at risk

2.3.1.5. Verify that activities including management review are carried out as scheduled.

2.3.1.6. Verify that continuous training are being conducted. 2.3.2. On-site Observations

2.3.2.1. Verify that HACCP/GMP programs are effectively maintained 2.3.2.2. Verify accuracy of flow chart and that any changes have

been updated. 2.3.2.3. Verify CCP(s) are monitored as required by the HACCP Plan 2.3.2.4. Verify processes are operating within established critical

limits 2.3.2.5. Verify records are logged in accurately at time intervals

2.4. Discuss about the audit finding between the auditors.

Tajuk :

MANUAL PROSEDUR KERJA SKIM PENSIJILAN HACCP DAN GMP KEMENTERIAN KESIHATAN MALAYSIA

No. Dokumen : BKKM-MPK-AUDIT

Keluaran : 01 Pindaan : 00 Tarikh Kuatkuasa : 01 Januari 2015

3. EXIT MEETING: 3.1. Thank auditee for hospitality, cooperation and assistance 3.2. Circulate attendance list. 3.3. State that the critique is based on objective evidence presented and does

not mean that area not seen or mentioned are considered satisfactory. 3.4. Presentation of assessment findings and summary report to management

on the factory. 3.5. Issue corrective action request (CAR) and state the general impression

based on summary report for the non-conformance. 3.6. Remind the auditee for the duration below :

3.6.1. The auditee shall respond to the CAR(s) issued within two (2) weeks after onsite audit.

3.6.2. The auditee shall rectify the CAR(s) given and submit the updated document within six (6) months for follow-up audit.

3.6.3. For compliance and additional product audit, the auditee is given maximum one (1) year from the onsite audit date for the audit process to be completed and all corrective action to be taken satisfactorily.

3.7. Sign the CAR(s) form by auditee and auditors. 3.8. Lead Auditor shall give a copy of the document below to the auditee :

3.8.1. Copy of Audit Summary Report - AUDIT-7/2014 3.8.2. CAR Form – AUDIT-10/2014

3.9. Close the meeting.