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.

Required skills

Ability to:

identify systems under which non-conformance may be raised, including the provisions of the Therapeutic Goods Act as it relates to systems (e.g. customer complaints, product recalls and auditing)

identify relevant company policies and procedures relating to responding to non-conformance and confirm level of authority and responsibility for participating in these procedures

identify the components of the management system, including information recording systems (such as those to support traceability), identification of personnel responsible for assessing information and determining appropriate action, procedures to be followed in the event of a non-conformance, change management requirements and definitions of roles and levels of responsibility

participate in the investigation of causes and review of arrangements and procedures in response to a non-conformance, such as reviewing responses to previous incidents to assess effectiveness and/or developing recommendations on appropriate procedures

identify and/or develop the appropriate communication systems and channels for consulting with people affected by any proposed changes

use communication skills to interpret and complete work information to support operations of work team or area

demonstrate and support cooperative work practices within a culturally diverse workforce

Required knowledge

Knowledge of:

legal requirements relating to management of non-conformance

systems and responsibilities for identifying, investigating and responding to non-conformance

consultation and communication methods required to investigate possible causes and communicate changed practices and procedures

change management procedures and responsibilities, including the role of corrective and preventative actions

procedures for reviewing, amending and validation

information systems, technologies and software to access and analyse information

problem solving methods

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)