This unit is appropriate where internal audit processes are conducted to support externally audited programs. Auditing must occur in an area that the person is not directly responsible for and where they are required to follow a formal, structured process. In addition to this standard, an auditor would typically work within the audit procedures as outlined in ISO 10011. When conducting a food safety audit, FDFAU4003A Conduct food safety audits, should be used. When applied to the pharmaceutical industry, FDFPH2001A Apply Good Manufacturing Practice procedures should be selected to support the application of this unit. FDFPH2001A incorporates content covered in FDFOP2063A Apply quality systems and procedures and can be used as an alternative to this prerequisite unit for the pharmaceutical manufacturing sector. |
Participate in OHS processes | ||
Apply quality systems and procedures | ||
Participate in an audit process | ||
Participate in environmentally sustainable work practices | ||
ELEMENT | PERFORMANCE CRITERIA |
1. Plan an audit | 1.1. The purpose and scope of the audit is negotiated and agreed 1.2. Information and resources required to conduct the audit are identified and secured 1.3. An audit schedule is developed and negotiated to meet audit scope and timelines |
2. Prepare for an audit | 2.1. Audit information sample and collection tools are determined 2.2. Roles, responsibilities and authority levels of the audit team are identified and communicated to audit team members as appropriate 2.3. Affected work areas/personnel are informed of schedule and advised of their role in the process |
3. Monitor the audit process | 3.1. Information collected is adequate, representative and meets audit requirements 3.2. Information is analysed to assess adequacy of performance against program objectives 3.3. Records are reviewed to confirm compliance with the program 3.4. Compliance with the program is observed in the workplace 3.5. Areas requiring corrective action are identified 3.6. Obstacles to achieving audit within agreed timelines are identified and addressed |
4. Report and follow up audit outcomes | 4.1. Situations presenting an imminent and serious risk to the program objectives are identified and reported immediately in accordance with reporting requirements 4.2. Audit reports are prepared to address audit scope requirements 4.3. The results of the audit are communicated to appropriate personnel according to audit purpose and requirements 4.4. A corrective action plan is developed and negotiated within level of responsibility 4.5. Implementation of corrective action as set out in the corrective action plan is monitored and confirmed 4.6. Where corrective action does not meet the corrective action plan requirements, follow up action is taken/reported according to level of responsibility and audit purpose |
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Required skills |
Ability to: identify roles and responsibilities of personnel participating in the audit process establish and negotiate audit purpose and scope to meet the workplace and legislative requirements clarify program objectives and evaluation criteria to be applied, where appropriate, this includes identifying legal compliance requirements establish the audit sequence, activities and timelines identify roles, responsibilities and competencies required to conduct an audit and confirm that the required competencies are available within the project team, where appropriate identify and locate information required to conduct the audit review workplace documentation to confirm that required information is available select and apply appropriate data collection tools to provide information on both program outcomes and processes establish an audit plan and timetable and communicate the plan to relevant work areas/personnel, including allocating tasks to match requirements of the audit and competencies of the audit team assess information collected against program objectives and evaluation criteria to identify compliance/non-compliance identify any changes that have occurred in the workplace since initiating the program or since the last program audit that could affect program outcomes identify, investigate and record evidence of non-compliance assess severity of non-compliance and take immediate action to report non-compliance that presents an imminent and serious risk to achievement of program objectives (action must comply with company audit procedures and with legal responsibilities where relevant) based on the audit findings, assess the adequacy of the program under review, including verifying that information used to establish methods of controlling hazards is adequate and correct (technical experts/accessing external technical resources may be used to support verification. conclusions on audit outcomes should be objective and capable of duplication, given the evidence collected) where findings indicate either a failure to comply with the program or inadequacy of the program, investigate and determine the causes of non-conformance and identify corrective action requirements communicate audit findings, including corrective actions and timeframes with relevant work areas/personnel, such as negotiating/securing required resources report the findings of the audit in an appropriate format to meet the requirements of the workplace and legal compliance where relevant use communication skills to interpret and complete work information to support operations of work team or area demonstrate and support cooperative work practices within a culturally diverse workforce |
Required knowledge |
Knowledge of: the purpose and intent of the program being audited, including the requirements of relevant national, state and local government legislation relating to program purpose and requirements auditor roles, responsibilities and legal obligations as relevant to the audit purpose, including the responsibilities of both internal and external auditors, and the different types of auditors and of authorised officers who may be involved in the audit program legal responsibilities for reporting imminent and serious non-conformities requirements and procedures for certification/registration of auditors and authorised officers according to audit type the frequency and scope of audit requirements to meet legal obligations appropriate ethical conduct of auditors as set out in codes of ethics of auditors and additional requirements as may be determined by the workplace the purpose and stages involved in the audit process, such as compliance with ISO audit standards as appropriate to audit requirements workplace information and related information management systems techniques for collecting information, including appropriate sampling techniques, information collection methods and the strengths and weaknesses of each method to ensure data is adequate and representative, as well as an understanding of techniques identified by ISO 10011 data analysis methods relevant to the audit process communication skills and techniques, such as appropriate questioning, observation and related communication skills to support information collection, appropriate to the workplace technical knowledge relevant to the program being audited in order to verify the adequacy of: hazard identification processes control methods, including industry standards/practice monitoring and record keeping validation processes corrective action/process improvement procedures where program control methods or limits vary from industry standards or where there are no industry standards, technical knowledge required to assess data used by the business to validate acceptable limits (this may be addressed by identifying and involving appropriate technical expertise) competency standards and related assessment and training options to support program implementation information management and communication systems to document and communicate audit outcomes in appropriate formats |
The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package. | |
Overview of assessment | Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations. |
Critical aspects for assessment and evidence required to demonstrate competency in this unit | Evidence of ability to: determine scope of and purpose of audit schedule audit and make required arrangements establish information collection parameters select information collection techniques collect and analyse information ensure compliance develop and communicate required corrective action plan complete workplace records as required apply safe work practices and identify OHS hazards and controls. |
Context of and specific resources for assessment | Assessment must occur in a real or simulated workplace where the assessee has access to: workplace program and related documentation relevant legislation audit procedures and standards, including any external standards relevant to the audit, such as ISO standards advice on related technical industry standards and codes of practice information systems and data collection technology reporting formats/requirements workplace/personnel access as required to collect data/observe compliance. |
Method of assessment | This unit should be assessed together with core units and other units of competency relevant to the function or work role. In addition, the following optional units may be relevant: FDFOP2015A Apply principles of statistical process control FDFPPL3004A Lead work teams and groups FDFPPL5001A Design and maintain programs to support legal compliance BSBRES4001A Analyse and present research information. For information on how to assess this unit of competency and who can assess, refer to the Assessment Guidelines for this Training Package. For some types of audits, auditors are required to comply with assessment arrangements specified by relevant regulatory bodies. Where this is the case, these separate assessment requirements must also be met. |
Guidance information for assessment | To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities. |
The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included. | |
Audits | Audits may be conducted against workplace programs and/or legislative requirements undertaken for advisory or regulatory purposes and may be led by internal or external auditors conducted by individuals or involve an audit team |
Corrective action plan | A corrective action plan identifies: non-conformance corrective actions date by which action must be taken any other follow up requirements Depending on the nature and scope of an audit, the auditor may not be responsible for identifying appropriate corrective action. However, it is a requirement that they have the technical knowledge to do so or involve a technical expert |
Communication skills and techniques | Appropriate communication skills and techniques must take account of English language, literacy and technical skill base of workplace personnel |
Information collection | Information collection typically includes: reviewing workplace records conducting interviews observing workplace practice collecting other relevant information as required |
Procedures and techniques | Detailed procedures and techniques for conducting audits are currently defined by ISO 10011 (this standard is under review) |
Unit sector | People management/planning/logistics |
This unit contains employability skills. |
Not applicable.