Elements and Performance Criteria

The range of variables relates to the unit of competency as a whole. It allows for different work environments and situations that will affect performance.
Where reference is made to industry Codes of Practice, and/or Australian/international standards, it is expected the latest version will be used.
This unit of competency is relevant to experienced technical officers and supervisors who initiate continuous improvements.
Quality audits and evaluations for the work area may be undertaken as an individual or as part of a team.

Quality manuals and procedures may be based on standards, such as
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO 9001, 9002 and 9003 series Quality management and quality assurance standards
AS10010013-2003 Guidelines for quality management systems documentation
National Association of Testing Authorities (NATA) requirements
Good laboratory practice (GLP), good manufacturing practice (GMP), the British Standard BS 5750 and the OECD Principles of good laboratory practice, Therapeutic Goods Administration - Code of GMP
AS1199 Sampling procedures and tables for inspection by attributes
AS1399 Guide to AS1199
HACCP principles
international testing methods (eg, AOAC, CODEX).

Quality audits could 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 may involve
supervisors, managers and quality managers
laboratory and production personnel
customers and suppliers
auditors.

Reporting may involve
verbal responses
data entry into laboratory or enterprise databases
written reports.

Documentation could 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 OHS, EO, environmental legislative requirements
industrial awards, enterprise agreements.

Health, safety and environment
All operations to which this unit applies are subject to stringent health, safety and environmental (HSE) requirements, which may be imposed through State or Federal legislation, and these must not be compromised at any time. Where there is an apparent conflict between performance criteria and HSE requirements, the HSE requirements take precedence.
All operations assume the potentially hazardous nature of samples and require standard precautions to be applied. Users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council and State and Territory Departments of Health. All operations are performed in accordance with standard operating procedures.

The Evidence Guide describes the underpinning knowledge and skills that must be demonstrated to prove competence.
Critical aspects of competency
Competency must be demonstrated in the ability to perform consistently at the required standard. Candidates must be able to implement and monitor defined quality system requirements and initiate continuous improvements within the work area.

In particular, assessors should look to see that the candidate:

applies effective problem identification and problem solving techniques
strengthens customer service through a focus on continuous improvement
implements, monitors and evaluates quality systems in the work area
initiates quality processes to enhance the quality of performance of individuals and teams in the work area
gains commitment of individuals/teams to quality principles and practices
implements effective communication strategies
encourages ideas and feedback from team members when developing and refining techniques and processes
analyses training needs and implements training programs
prepares and maintains quality and audit documentation.

Underpinning knowledge

Competency includes the ability to apply and explain:

relevant national and international quality standards and protocols
the enterprise quality system
continuous improvement principles
enterprise organisational structure, delegations and responsibilities
SOPs for the technical work performed in work area
communication/reporting protocols
policy and procedure development processes
enterprise information systems management
relevant health, safety and environment requirements.
The candidate also requires sufficient knowledge of enterprise business goals and key performance indicators to implement continuous improvement processes effectively.

Assessment context and methods
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.

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. Questioning techniques should suit the language and literacy levels of the candidate.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLCOM500B Provide information to customers.

Resource implications

Resources may include:

quality manuals and documentation
quality tools, such as Pareto charts, SWOT Analysis, PDCA (plan, do, check, act)
quality and customer data.

This competency in practice
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.
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.
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.

The seven key competencies represent generic skills considered for effective work participation. The bracketed numbering against each of the key competencies indicates the performance level required in this unit. These are stand-alone levels and do not correspond to levels in the Australian Qualifications Framework (AQF).
Level (1) represents the competence to undertake tasks effectively
Level (2) represents the competence to manage tasks
Level (3) represents the competence to use concepts for evaluating and reshaping tasks.
Communicating ideas and information
(3)

Collecting analysing and organising information
(3)

Planning and organising activities
(3)

Working with others and in teams
(3)

Using mathematical ideas and techniques
(2)

Solving problems
(3)

Using technology
(3)