Elements and Performance Criteria

RANGE STATEMENT
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.
Codes of practice
Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used
Standards, codes, procedures and/or enterprise requirements
Standards, codes, procedures and/or enterprise requirements may include:
Australian and international standards, such as:
AS ISO 10013-2003 Guidelines for quality management system documentation
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS 2243 Set:2006 Safety in laboratories set
AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans
AS/NZS ISO 14000 Set:2005 Environmental management standards set
AS/NZS ISO 9000 Set:2008 Quality management systems set
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
Australian Dangerous Goods Code
gene technology regulations
OHS national standards and codes of practice
principles of good laboratory practice (GLP)
testing procedures and specific method collections for industry sectors:
Association of Analytical Communities International (AOAC International) Official Methods of Analysis
Workplace documentation
Workplace documentation may include:
workplace procedures, SOPs and operating manuals
test procedures
sampling procedures (sampling, preparation, labelling, storage, transport and disposal)
evaluation of materials or products
instructions for equipment installation, commissioning, calibration and maintenance
safety requirements for equipment, materials or products
cleaning, hygiene and personal hygiene requirements
methods for extraction or manufacture of a product
risk evaluation, monitoring or control procedures
compliance/non-compliance reports
quality system and continued improvement processes
incident and accident/injury reports
permits
schematics/work flows/laboratory layouts
instructions to comply with new legislation, standards, guidelines and codes
stock records/inventory
training program contents
waste minimisation and disposal
Items of equipment and systems
Items of equipment and systems may include:
online information systems, databases, record and filing systems
computer equipment
Communication
Communication may be with:
supervisors and managers (laboratory, quality and customer service)
other laboratory or production personnel
members of the public, customers and suppliers
external auditors, regulation and licensing/accreditation authorities, such as National Association of Testing Authorities (NATA)
Occupational health and safety (OHS) and environmental management requirements
OHS and environmental management requirements:
all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time
all operations assume the potentially hazardous nature of samples and require standard precautions to be applied
where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health

EVIDENCE GUIDE
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

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Assessors should ensure that candidates can:
analyse, draft and amend enterprise documentation in accordance with specifications
complete documentation in a clear and concise manner that is easily understood by others and in accordance with enterprise requirements/ specifications
recognise problems in systems and documentation
use internal and external information sources efficiently
critically analyse information
prepare documentation that is accurate, free from editorial errors and omissions, and in accordance with requirements
prepare documentation that is easily understood by the intended audience
obtain and include relevant feedback on draft documentation
communicate information and developments in the appropriate manner
complete the preparation and distribution of documents in the given time.

Context of and specific resources for assessment
This unit of competency is to be assessed in the workplace or simulated workplace environment.
This unit of competency may be assessed with:
MSL916004A Maintain registration and statutory or legal compliance in work/functional area
MSL936001A Maintain quality system and continuous improvement processes within work/functional area
MSL946001A Implement and monitor OHS and environmental management systems.
Resources may include:
information directories and databases
enterprise documents and procedures.

Method of assessment
The following assessment methods are suggested:
examination of a range of relevant enterprise documentation developed by the candidate
feedback from peers and supervisors that enterprise procedures were followed and that the documentation is accurate and user friendly.
In all cases, practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly.
Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.
Access must be provided to appropriate learning and/or assessment support when required.
The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice
Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.
Environmental
A water sample thought to contain cadmium had been logged for analysis. Later that day, the technician designated to perform the analysis advised the laboratory supervisor that the procedures had not yet been revised to suit the newly installed analytical equipment. The supervisor created a draft procedure document for the revised procedure and passed it, with an explanation of the reasons for the change, to the appropriate personnel for authorisation. The draft document was approved and the supervisor issued the revised procedures as a control document. The supervisor notified all relevant personnel of the change, removed the old procedures, replaced it with the new document and entered the change in the document control register.
Food processing
Two senior technicians in the laboratory of a food processing company hazard analysis and critical control points (HACCP) team suggested extensive changes to the way the laboratory functioned so that it better supported the HACCP system. The technicians reviewed the existing HACCP documentation and legislation and revised the laboratory documentation that was relevant to the HACCP system. They also organised in-house training to provide each member of the laboratory team with the knowledge and skills essential for successful implementation of this system. Overall, the adoption of a HACCP plan by the company proceeded with relatively few problems, in part because of the involvement of the laboratory staff and the training provided by the company.