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 1199 Sampling procedures and tables for inspection by attributes
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans
AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment
AS ISO 10013-2003 Guidelines for quality management system documentation
AS/NZS ISO 9000 Set:2008 Quality management systems set
AS 1199 Sampling procedures and tables for inspection by attributes
Association of Analytical Communities International (AOAC International) Official Methods of Analysis
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
BS 5750 Quality systems
Codex Alimentarius standards
customer specific requirements/standards
enterprise and customer product specifications
hazard analysis and critical control points (HACCP) principles
National Association of Testing Authorities (NATA) Accreditation programs requirements
National Health and Medical Research Council (NHMRC) Guidelines
national measurement regulations and guidelines
principles of good laboratory practice (GLP)
quality manuals and procedures
Therapeutic Goods Regulations 1009
Quality audits
Quality audits may include:
regular checks of laboratory procedures
daily and weekly checks of specimen reception, instrumentation and results for control and standard samples to identify non-conformance and problem areas
maintenance of appropriate certified reference materials (CRMs)
participation in external quality assurance programs
Communication
Communication may involve:
supervisors, managers and quality managers
laboratory and production personnel
customers and suppliers
auditors
Reporting
Reporting may include:
verbal responses
data entry into laboratory or enterprise databases
written reports
Documentation
Documentation may include:
sampling plans
enterprise quality manual
quality (certification or registration) requirements
audit documents
performance plans and reports
training records and/or plans
workplace procedures relating to occupational health and safety (OHS), equal opportunity (EO) and environmental legislative requirements
industrial awards and enterprise agreements
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:
implement and monitor defined quality system requirements and initiate continuous improvements within the work area
apply effective problem identification and problem solving techniques
strengthen customer service through a focus on continuous improvement
implement, monitor and evaluate quality systems in the work area
initiate quality processes to enhance the quality of performance of individuals and teams in the work area
gain commitment of individuals/teams to quality principles and practices
implement effective communication strategies
encourage ideas and feedback from team members when developing and refining techniques and processes
analyse training needs and implement training programs
prepare and maintain quality and audit documentation.

Context of and specific resources for assessment
This unit of competency should be assessed in a laboratory environment that either meets Australian standards for working laboratories or is accredited by NATA or the Royal College of Pathology, as appropriate.Competency in this unit should be assessed over a sufficient period of time to enable the candidate to initiate and implement improvements.
This unit of competency may be assessed with:
MSL915001A Provide information to customers.
Resources may include:
quality manuals and documentation
quality tools, such as Pareto charts, strengths, weakness, opportunities, threats (SWOT) analysis and plan, do, check, act (PDCA)
quality and customer data.

Method of assessment
The following assessment methods are suggested:
observation of the candidate leading a quality improvement team
review of verified reports of improvement initiatives and/or projects conducted by the candidate
feedback from peers, team members, supervisors, quality manager and customers
review of quality documentation prepared and maintained by the candidate
review of training places prepared by the candidate for personnel in the work area
review of audit processes and outcomes generated by the candidate
questions to assess underpinning knowledge of procedures and contingency management.
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.
Manufacturing
The laboratory supervisor with a pharmaceutical company had participated in the production of a company wide quality manual. This manual was distributed to the various work teams and an induction program for all workers was undertaken to familiarise them with the demands of the quality system. A transient, sharp improvement in laboratory operations was observed after which the quality metrics fell (although not to pre-quality system levels). The supervisor investigated this phenomenon and found that many of the analytical specifications determined by the company were detailed in the quality manual and nowhere else. Put simply, after an initial period during which laboratory personnel consulted the manual for guidance, there was a tendency for the personnel to rely more on their memories and less on the manual. The supervisor made it clear to personnel that 'guessing' procedures and methodologies was unacceptable. If they were uncertain of something they must consult the manual. Awareness of this problem allowed the supervisor to be more vigilant in monitoring laboratory operations and personnel eventually developed the habit of referring to the manual as required. A subsequent review of the manual went smoothly and efficiently. The staff were familiar with the manual's strengths and shortcomings and had made annotations for improvements that were readily incorporated during the review.
Environmental
Collection of botanical specimens for research purposes required personnel to record data at the time of collection in a prescribed format. A quality audit conducted by the laboratory supervisor indicated that some documentation was incomplete. The supervisor also found that sometimes documentation was completed later, from memory, rather than in the field. The supervisor met with the collectors involved, reinforced the enterprise protocols, explained the importance of diligent record keeping in achieving valid research outcomes and gained a renewed commitment to quality from the personnel. Subsequent quality audits indicated that the personnel had met their commitment and the research work was no longer jeopardised.
Food processing
The laboratory supervisor of a food processing company had noted over recent years that the requests of some customers were virtually impossible to fulfil. For example, one customer wanted a bleached flour which had not undergone any chemical treatment or adulteration for a particular market niche. Another customer wanted analytical results within an unrealistic timeframe. While none of these requests had caused serious friction between the company and its customers, the supervisor decided to take a proactive stance to address the not altogether unreasonable ignorance of some customers. After consulting with the laboratory manager, the supervisor invited all customers to tour the laboratory, during which the aims and limitations of the analytical procedures were explained. The tour gave customers the opportunity to assess their demands of the company and generate more realistic ideas for modifying the company's products to suit their needs. The outcomes of this exercise were that company-customer relations were improved, the future expectations of some customers were more practical and the company's ongoing program of product improvement was facilitated by customer input.