Clause 2.1.1 Forming multi-functional team Note: This i both © GMP (on-site) Ausit @ Documentation (desi top) Audit requirement. ‘What ‘A multr-cisciplinary t2am shall implement and reviewthe AARA. The team shall be composed of representative ofthe following departments — quaity, technical, engineering/msintenance. procuction/operations, and any other relevant departments. External expertise can be svailed of, in case there is no expertse in the organisation. This expert may be used to analyse the organisation's HARA. Nonetheless, the organisation ie wholly responsible for daly management of its own HARA Why ‘A multidisciplinary tam ensure that there is complete coverage of potential hazards and risks encountered or potentially encountered in the operations of the orgenisation which may affect the pprocuct quality, legaity, functionality, etc. this team will be completely reeponcible to develop, reviewand maintain the HARA on a routine besis. Even if externel expertise is eveiled of the deily management of the HARA shall always remsin the responsitility ofthe organisation as third party can only offer cancultancy and cannot be responsible for it ‘The HARA team Is selected and composed of representatives trom crucal process / departnenis as follows. "Plan Determine the crucial proceasand its competent process owners based on thar qualficstions, Industry experience and training on the subject. ‘The representatives are selectedfrom the processes / departments mainly Quality, Production, and Maintenance. Adgitional reprezentative from supporting / zervice departments such as HR, Logit, Marketing may be selected and when needed Educational Qualification background (printing, nacksging, quality) 's also a deciding factor on being 3 ‘team member in the HARA team. ‘he representatves are also selected on basis oftheir experience on the industry (packaging| as also their training on the subject mater (internal / external) ‘These three selection parameters ectabliznes their comaetency forthe HARA team. ~ check The team members will be ensuredto have up-to-date competencies Also, new employees or exit of existing members may influence the compilation of the HARA team If there are any changes in the Hazard and Risks in the global scale, or there are any naw employees recruitedin the organisation which can add value to the HARA team, oran existing HARA team member has exited the organisation, the HARA team composition may be changed accordingly after analysis of competencies When ‘The team will be reviewed st least once Bnnually oF as end when the above fectors happen, ‘where The List of HARA Team Members. ‘Who Responsible Consulted ‘Accountable Taformed MR. Senior Management | Head of Division ‘Senior Management Standard HARA Team, HARA Team