Application
This unit of competency describes the skills and knowledge to evaluate a product/application brief and to contribute to the development of products and applications to meet the requirements of the brief.
This unit applies to senior technical officers, laboratory supervisors and technical specialists working in all industry sectors. All operations must comply with relevant standards, appropriate procedures and/or workplace requirements.
No licensing or certification requirements exist at the time of publication. However, regulations and/or external accreditation requirements for laboratory operations exist, so local requirements should be checked. Relevant legislation, industry standards and codes of practice within Australia must also be applied.
Elements and Performance Criteria
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. | ||
1 | Scope the development project | 1.1 | Confirm details of new product/application brief |
1.2 | Specify new product/application requirements | ||
1.3 | Analyse existing products (internal and external to workplace) to determine if they meet customer need | ||
1.4 | Interpret and apply relevant Acts, regulations and codes of practice | ||
1.5 | Prepare product/application development plan | ||
1.6 | Obtain approval for development plan from appropriate personnel | ||
2 | Set scope of project | 2.1 | Estimate resource requirements, including staffing, equipment and materials needed to undertake the project |
2.2 | Identify roles and responsibilities of project team members | ||
2.3 | Identify quality requirements and quality standards | ||
2.4 | Identify and document project timelines taking into account any constraints | ||
3 | Develop new product formulation | 3.1 | Prepare documentation for new product pilot batch |
3.2 | Evaluate/recommend materials for new product/application | ||
3.3 | Calculate required quantities of materials and adjust for properties as appropriate | ||
3.4 | Develop/modify products in pilot batch scale in accordance with workplace and regulatory requirements | ||
3.5 | Arrange for product evaluation against development brief | ||
3.6 | Modify product/application to meet evaluation recommendations | ||
3.7 | Edit documentation and issue to appropriate personnel | ||
3.8 | Recommend and evaluate packaging for new product/application | ||
3.9 | Prepare protocol for stability (shelf) testing of new product/application | ||
4 | Assist with preparation of quality/ regulatory compliance procedures/ materials | 4.1 | Develop in-process and laboratory testing protocols |
4.2 | Prepare product labelling and submit for approval | ||
4.3 | Assist in product and analytical method validation | ||
4.4 | Implement an effective plant hygiene and asepsis program | ||
4.5 | Develop good manufacturing principles for medicinal products (GMP)/principles of good laboratory practice (GLP) protocols for approval by appropriate personnel | ||
4.6 | Prepare standard operating procedures (SOPs) for quality and laboratory-related procedures | ||
4.7 | Prepare work health and safety (WHS) procedures for the laboratory and manufacturing environment and submit for approval | ||
5 | Document and report project outcomes | 5.1 | Document and report project outcomes |
5.2 | Complete project reporting requirements | ||
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential to performance.
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency.
Competency Field
Testing