Required skills

Ability to

identify systems under which nonconformance may be raised including the provisions of the Therapeutic Goods Act as it relates to systems eg customer complaints product recalls and auditing

identify relevant company policies and procedures relating to responding to nonconformance 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 nonconformance 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 nonconformance such as reviewing responses to previous incidents to assess effectiveness andor developing recommendations on appropriate procedures

identify andor 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 nonconformance

systems and responsibilities for identifying investigating and responding to nonconformance

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 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 nonconformance 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 nonconformance 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 nonconformance 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 nonconformance

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 nonconformance

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

FDFPHA Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPPLA Optimise a work process

FDFPPL4004A Optimise a work process

MSACMCA Lead change in a manufacturing environment

MSACMC410A Lead change in a manufacturing environment

MSACMTA Undertake process capability improvements

MSACMT450A Undertake process capability improvements.

Guidance information for assessment

To ensure consistency in ones 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

Non-conformance

Implementation plan

Legal requirements

Systems