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.
Non-conformance
Non-conformance may be assessed against policies, procedures, specifications and audit requirements
Implementation plan
An implementation plan includes but is not limited to:
allocation of responsibilities and roles
establishing and negotiating timelines and resources
documentation review
appropriate authorisation
identification of training/skill development requirements
Legal requirements
Legal requirements are those prescribed in the Therapeutic Goods Act and other relevant legislation, regulations and codes (relating to product and markets)
Systems
Systems and responsibilities for identifying, investigating and responding to non-conformance can include but are not limited to:
corrective and preventative action
customer complaints
product recall
audits (internal and external)

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
Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation including production records and data management systems related to managing non-conformance that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide access to workplace policies and procedures to support the management of non-conformance to meet the requirements of the Therapeutic Goods Act.

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Evidence of participation in a team responsible for responding to deviation and non-conformance. This includes providing evidence developed by the candidate to:
identify deviation
identify and determine the nature of non- conformance
implement required corrective action and reporting
investigate the causes of a non-conformance
identify changes to company systems and procedures required to minimise the risk of recurrence
follow procedures to participate in proposing changes
develop and implement required preventative action.

Context of and specific resources for assessment
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment.
Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects.
Resources for assessment
copies of the relevant Act, regulations, codes and guides
workplace documentation relating to responding to non-conformance
real or simulated workplace context.

Method of assessment
This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice
FDFPPL4004A Optimise a work process
MSACMC410A Lead change in a manufacturing environment
MSACMT450A Undertake process capability improvements.

Guidance information for assessment
To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.