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 represents a thorough examination of various aspects of the quality system. Often laboratory supervisors 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.

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

Information sources may include
enterprise quality manual
any documentation related to the quality elements being audited
customer complaints
training records
data records
certification documentation from clients/suppliers
material/equipment specifications.

Quality manuals and procedures may be based on standards, such as
ISO 9001, 9002 and 9003 series Quality management and quality assurance standards
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
Good laboratory practice (GLP), good manufacturing practice (GMP), the British Standard BS 5750 and the OECD Principles of good laboratory practice
OHS legislation and codes, regulations and Australian standards that apply to the tasks undertaken in the workplace.

Quality improvement tools and techniques may include
run charts, control charts, histograms and scattergrams to present QC data
PDCA (plan, do, check, act)
Ishikawa fishbone diagrams, cause and effect diagrams
logic tree
similarity/difference analysis
Pareto charts and analysis
forcefield/SWOT analysis
process capability.
Communication may involve managers, customers and suppliers, laboratory and production personnel, other personnel with QA responsibilities.

Reporting may involve
verbal responses,
judgement and recommendations
written report, presentations
data entry into laboratory or enterprise databases.

Documentation could include
audit documents
enterprise quality manual, HACCP plans
safety procedures, standard operating procedures (SOPs), work instructions
quality (certification or registration) requirements.

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 prepare and conduct an audit of the quality system following enterprise procedures. This includes the ability to implement corrective action and monitor its effectiveness

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

implements effective communication strategies before, during and after an audit
collects and analyses all necessary data/documentation/records
encourages suggestions and feedback from team members when developing and refining processes
monitors and reviews the team's performance
applies effective problem identification and problem solving techniques
prepares and maintains quality and audit documentation
makes recommendations based on the findings of non-conformance items
initiates and evaluates corrective action and makes appropriate adjustments.

Underpinning knowledge

Competency includes the ability to apply and explain the:

enterprise quality system, relevant national and international quality standards and protocols
audit process
continuous improvement principles
importance of identifying and reporting non-conformance
documentation processes
problem solving techniques to identify causes and options to remedy problems
workplace communication reporting requirement and procedures
enterprise organisational structure, responsibilities and delegations
relevant health, safety and environment requirements.
An awareness of the laboratory's business goals and key performance indicators is also required as a basis for conducting internal audits.`

Specific industry

Additional knowledge requirements may apply for different industry sectors. For example, in food processing:

incorporate food safety and/or HACCP plan requirements into audit
monitor and verify critical control limits.

Assessment context and methods
This unit of competency is to be assessed in the workplace or simulated environment. Ideally, competency should be assessed within the context of a team based internal quality audit.
Competency in this unit should be assessed over a sufficient period of time to enable the candidate to prepare and conduct the audit, report the findings and implement and evaluate any corrective action.

The following assessment methods are suggested:

observation of the candidate's performance at key points during the audit
review of data and reports obtained from audit records
review of documentation completed by the candidate as part of the development of the audit process
feedback from team members
feedback from management regarding the implementation of the internal audit.
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:

PMLQUAL600B Maintain quality system and continuous improvement processes within work/functional area
PMLTEAM600B Manage and develop teams.

Resource implications

Resources may include:

quality manuals and documentation
quality system requirements - AS/NZS ISO 9001:1994.

This competency in practice
A new laboratory is being planned and the senior technical officer has been included in the steering committee to prepare the brief. The committee has decided that the preparation of the brief will include an audit of the safety and operating standards of the current laboratory. The aim of the audit will be to compare the current safety operations and facilities that are acceptable within the framework of the current premises with those of a modern building. The audit will monitor equipment, storage facilities and current methodologies in order to determine the necessary infrastructure changes that might be incorporated into the plan, or changes in methodologies that would bypass the need for the building changes through a change in equipment.
There have been a few problems in the sample reception area. Not all tests specified in requests have been allocated and, on a few occasions, a test was deleted because a technical assistant decided that there was insufficient sample provided. The supervisor has decided that the processing system should be reviewed and the reasons for the mistakes and omissions identified. After tracking the sample arrival, processing, labelling and distribution, the supervisor noted that the technical assistants often could not identify the sample test code. Despite the instruction to seek assistance, they did not contact a supervisor if she/he could not be approached immediately. Sometimes they put the sample aside for the supervisor's attention and it was forgotten over the shift change. On other occasions, they assigned a test code in good faith. As a result of the audit, a database of the test codes, sample requirements, distribution destination and conditions for storage was established at sample reception. The technical assistants were shown how to access information that they might require if the supervisor was not available. This action reduced the number of mistakes and the frequency of test omissions, and improved throughput of samples.
Following an internal audit, a major non-conformance was identified which had resulted in a beverage label listing an ingredient that was not present. A corrective action had been made requiring that a new form be generated for release of label details from the purchasing department. The laboratory supervisor was given the responsibility as part of the audit team to follow up three weeks later and confirm that the corrective action had been completed. The laboratory supervisor gathered the data and a copy of the corrective action report and organised a meeting with staff from the purchasing department. During the meeting, the laboratory supervisor checked the revised quality form that now included the signature of the authorising officer from the purchasing department. The laboratory supervisor also reviewed the quality procedures to ensure that the new form's code was updated and that all old copies were removed. The report was then presented to the audit team for final approval and signing off.

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
(3)

Solving problems
(3)

Using technology
(2)