Unit of competency

Modification History

Application

This unit of competency describes the skills and knowledge to prepare for, conduct and document an internal audit of aspects of the laboratory's quality system. It also covers the implementation of the identified corrective action and opportunities for improvement and the monitoring of their effectiveness.

This unit applies to senior technical officers and laboratory supervisors working in all industry sectors. These people play a key role in the audit team due to their knowledge of the quality system and their broad technical expertise and specialised knowledge of procedures and technology. This unit of competency requires a thorough examination of various aspects of the quality system.

No licensing or certification requirements exist at the time of publication. However, regulations and/or external accreditation requirements for laboratory operations exist, so local requirements should be checked. Relevant legislation, industry standards and codes of practice within Australia must also be applied.

Pre-requisite Unit

Nil

Competency Field

Quality

Elements and Performance Criteria

Foundation Skills

This section describes those language, literacy, numeracy and employment skills that are essential to performance.

• Oral communication skills to:

• encourage suggestions and feedback from team members to develop improved work practices or processes
• interact effectively with supervisors, managers, laboratory and/or production personnel before, during and after the audit.

Other foundation skills essential to performance are explicit in the performance criteria of this unit.

Unit Mapping Information

Equivalent to MSL936002 Conduct an internal audit of the quality system, Release 1.

Links

MSL Laboratory Operations Companion Volume Implementation Guide is available from VETNet - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=5c63a03b-4a6b-4ae5-9560-1e3c5f462baa

Assessment requirements

Modification History

Performance Evidence

There must be evidence the candidate has completed the tasks outlined in the elements and performance criteria of this unit, and:

• effectively prepared for, conducted and documented at least 1 internal audit of at least 1 aspect of the laboratory's quality system in accordance with workplace procedures.

Knowledge Evidence

There must be evidence the candidate has knowledge of:

• workplace quality system, plans and documentation and relevant national and international quality standards and protocols that apply in work area
• workplace organisational structure, delegations and responsibilities, and information management systems
• importance of identifying, reporting and addressing non-conformance
• laboratory's business goals and key performance indicators (KPIs)
• continuous improvement principles and techniques:

• run charts, control charts, histograms and scattergrams to present quality control data
• plan, do, check, act (PDCA)
• Ishikawa fishbone diagrams; cause and effect diagrams; logic tree; similarity/difference analysis; Pareto charts and analysis; force field/strengths, weaknesses, opportunities, threats (SWOT) analysis
• process capability

• registration/licensing and/or National Association of Testing Authorities (NATA) accreditation requirements
• problem-solving techniques to identify causes and options to remedy problems
• elements and components of a quality system:

• responsibilities of personnel within quality system
• contract review
• purchasing
• design control
• process control, control of customer-supplied product, product identification and traceability
• inspection and testing, control of inspection, measuring and test equipment, and inspection and test status
• statistical analysis, internal quality audits, and corrective and preventative action
• control of documents, data and quality records
• control of non-conforming product
• handling, storage, packaging, preservation and delivery
• training
• servicing.

Assessment Conditions

Skills must have been demonstrated in the workplace or in a simulated environment that reflects workplace conditions and contingencies. The following conditions must be met for this unit:

• use of suitable facilities, equipment and resources, including:

• documentation, including audit documents, workplace quality manual, and quality (certification or registration) requirements
• safety procedures, SOPs and work instructions

• modelling of industry operating conditions, including:

• interactions with managers and laboratory operations personnel.

Links

MSL Laboratory Operations Companion Volume Implementation Guide is available from VETNet - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=5c63a03b-4a6b-4ae5-9560-1e3c5f462baa