Certificate IV Evidence & Assessment Guide MSL934002A Apply Quality Systems & Continuous Improvement Processes

Transcription

1 Certificate IV Laboratory Techniques (Road Industry) Evidence & Assessment Guide MSL934002A Apply Quality Systems & Continuous Improvement Processes Completion Summary Student Signature Assessment Result (AC or NC) Date of Completion Assessor Signature

2 A. Final Assessment Report Student assessment readiness Name of student Signature of student Date I agree that: I am comfortable with completing assessment of this unit I understand why the assessment is taking place I understand my right of appeal Competency-based assessment has been explained to me Discussion about special considerations or needs I have has taken place OH&S issues relating to the assessment have been considered My assessor has related my work role to the range statement Non-RTO technical expert/assessor details YES NO Name Position Role Acting as technical expert assisting RTO assessor Assessor (non-rto) I have a Cert IV in workplace training & assessment Signature Date RTO details RTO Hunter TAFE [CFFET] RTO Representative Signature Date Overall Assessment Competent Not Yet Competent Date : Comments (please supply Action Plan) 1

3 B. Unit summary This unit of competency covers the exercise of good laboratory practice and effective participation in quality improvement teams. Personnel are required to ensure the quality and integrity of their own work, detect non-conformances and work with others to suggest improvements in productivity and quality. satisfy quality system requirements in daily work analyse opportunities for corrective and/or optimisation action recommend corrective and/or optimisation actions participate in the implementation of recommended actions participate in the development of continuous improvement strategies What do I need to be able to do? The following are the absolute musts that a trainee needs to meet in order to acquire this unit of competency: use the enterprise's quality systems and business goals as a basis for decision making and action apply all relevant procedures and regulatory requirements to ensure the quality and integrity of the products/services or data provided apply and promote sustainable energy principles and work practices detect non-conforming products or services in the work area follow enterprise procedures for documenting and reporting information about quality contribute effectively within a team to recognise and recommend improvements in productivity and quality apply effective problem solving strategies implement and monitor improved practices and procedures. What do I need to do? To demonstrate competency in this unit, you are required to: collect documentation (or other evidence) as listed in the Evidence Portfolio table (section D) complete the required Assignments (section E) answer the required Knowledge Questions (section E) have your supervisor complete the Third Party Report checklist (section F) Competency in this unit will be assessed in conjunction with the following units: MSL924001A Process and interpret data MSL973001A Perform basic tests MSAENV272A Participate in environmentally sustainable work practices 2

4 C. Self-assessment guide Use the table below to identify if there are any gaps in your current level of knowledge, expertise and skills, related to this unit. If so, you should consult with your supervisor and/or the course coordinator to determine what training is required. Note that this table will not be used as part of the assessment of your competency. Access information on quality system requirements for own job function Record and report quality control data in accordance with quality system Follow quality control procedures to ensure products, or data, are of a defined quality as an aid to acceptance or rejection Recognise and report non-conformances or problems Conduct work in accordance with sustainable energy work practices Promote sustainable energy principles and work practices to other workers Compare current work practices, procedures and process or equipment performance with requirements and/or historical data or records Recognise variances that indicate abnormal or sub-optimal performance Collect and/or evaluate batch and/or historical records to determine possible causes for sub-optimal performance Use appropriate quality improvement techniques to rank the probabilities of possible causes Analyse causes to predict likely impacts of changes and decide on the appropriate actions Identify required changes to standards and procedures and training Report recommendations to designated personnel Implement approved actions and monitor performance following changes to evaluate results Implement changes to systems and procedures to eliminate possible causes Document outcomes of actions and communicate them to relevant personnel Can I do this? Tick when Yes 3

5 Can I do this? Tick when Yes Review all relevant features of work practice to identify possible contributing factors leading to sub-optimal performance Identify options for removing or controlling the risk of sub-optimal performance Assess the adequacy of current controls, quality methods and systems Identify opportunities to continuously improve performance Develop recommendations for continual improvements of work practices, methods, procedures and equipment effectiveness Consult with appropriate personnel to refine recommendations before implementation of approved improvement strategies Document outcomes of strategies and communicate them to relevant personnel 4

6 D. Evidence Portfolio This is a list of the documentation (paper or electronic) you should collect (if possible) to help prove your competency. If it is an item that you do not possess (eg a training certificate) then obviously you cannot submit it. If it is considered essential by your assessor, he/she will contact you. Please ensure that the material is clearly indicated with your name and also the document code. Photocopies are perfectly acceptable, and any sensitive information can be obscured. If you have any other pieces of evidence that you believe are relevant to this unit, and will help establish your competency, please include them, and log them in the table on the next page with an appropriate code number. See the Unit Guide (Section G). Code Evidence description Tick when collected E1 A SOP signoff sheet with your signature and the first page of the procedure itself E2 If you have been involved in the development or revision of an SOP, include documentary evidence of your part in the process E3 A page from an SOP that you use which shows the actions to be taken when a non-conforming item is detected E4 A run/control chart that shows your initials or similar E5 Documentation that describes two reference materials used in your laboratory. If you personally use reference materials, please provide records showing this E6 A procedure, or similar, that specifies or describes the use of retesting E7 A procedure which outlines the process for changing an existing standard procedure. 5

7 Extra evidence Code Evidence description Tick when collected When you have collected all the evidence that you believe is relevant, please send it to the Course Coordinator (post or ). Lara Passlow CFFET Hunter Institute Locked Bag 45 Hunter Region Mail Centre

8 E. Knowledge Assessment Assignments You are required to complete satisfactorily the following assignment(s) as part of proving your competency. Full descriptions of the required work must be downloaded from the unit s Downloads & Links page A You are required to document a troubleshooting exercise on a testing procedure that you are very familiar with. It will be particularly useful if it is one which has had a problem recently B You are required to either document an improvement process you have been part of OR outline how you would undertake a specified change. Questions You are required to answer the following questions as part of proving your competency. The answers should be included in a Word document and ed to the Course Coordinator, with the file named as 34002Q_familyname.doc, eg 34002Q_smith.doc 1. How does the term quality apply to the road materials you test? 2. How does the term quality apply to the test results you produce? 3. How do you know that the test results you personally are producing are of the required quality? 4. What is the difference between accuracy and precision? Why are both important? 5. What do you understand by the term validation? 6. Why is it necessary to calibrate measuring devices on a regular basis? 7

9 F. Third Party Assessment This report verifies that demonstrates the following competencies consistently. It should be completed by a supervisor of the student, who is familiar with their work in the areas covered by this unit. I confirm that the student: Date & Initials Comments Access information on quality system requirements for own job function Record and report quality control data in accordance with quality system Follow quality control procedures to ensure products, or data, are of a defined quality as an aid to acceptance or rejection Recognise and report non-conformances or problems Conduct work in accordance with sustainable energy work practices Promote sustainable energy principles and work practices to other workers Compare current work practices, procedures and process or equipment performance with requirements and/or historical data or records Recognise variances that indicate abnormal or sub-optimal performance 8

10 I confirm that the student: Date & Initials Comments Collect and/or evaluate batch and/or historical records to determine possible causes for sub-optimal performance Use appropriate quality improvement techniques to rank the probabilities of possible causes Analyse causes to predict likely impacts of changes and decide on the appropriate actions Identify required changes to standards and procedures and training Report recommendations to designated personnel Implement approved actions and monitor performance following changes to evaluate results Implement changes to systems and procedures to eliminate possible causes Document outcomes of actions and communicate them to relevant personnel Review all relevant features of work practice to identify possible contributing factors leading to sub-optimal performance Identify options for removing or controlling the risk of sub-optimal performance Assess the adequacy of current controls, quality methods and systems Identify opportunities to continuously improve performance 9

11 Develop recommendations for continual improvements of work practices, methods, procedures and equipment effectiveness Consult with appropriate personnel to refine recommendations before implementation of approved improvement strategies Document outcomes of strategies and communicate them to relevant personnel Supervisor s name Supervisor s signature Date 10

12 G. Unit Guide The following material is taken from the National Training Package document for this unit, and describes in detail the requirements and scope of the unit. Its main use could be in helping you to identify other evidence for your Portfolio. It is not required reading for you your assessor and resource designer have used it to develop the learning and assessment materials. Range statement Codes of practice Standards, codes, procedures and/or enterprise requirements Quality control procedures Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used Standards, codes, procedures and/or enterprise requirements may include: Australian and international standards, such as: AS ISO General requirements for the competence of testing and calibration laboratories AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment AS/NZS ISO 9000 Set:2008 Quality management systems set AS 1199 Sampling procedures and tables for inspection by attributes BS 5750 Quality systems Australia New Zealand Food Standards (ANZFS) Code Australian code of good manufacturing practice for medicinal products (GMP) customer specific requirements/standards enterprise and customer product specifications National Association of Testing Authorities (NATA) Accreditation programs requirements National Health and Medical Research Council (NHMRC) Guidelines national measurement regulations and guidelines principles of good laboratory practice (GLP) quality manuals and procedures Therapeutic Goods Regulations 1009 Quality control procedures may include: standards imposed by regulatory and licensing bodies enterprise quality procedures working to a customer brief or batch card and associated quality procedures 11

13 Methods for statistical analysis Problem solving techniques Quality improvement tools and techniques Sustainable energy principles and work practices Communication checklists to monitor job progress against agreed time, costs and quality standards preparation of sampling plans the use of hold points to evaluate conformance the use of inspection and test plans to check compliance Methods for statistical analysis may include: means median mode ranges standard deviations statistical sampling procedures Problem solving techniques may include: identifying inputs and outputs sequencing a process identifying and rectifying a problem step root cause analysis implementing preventative strategies Quality improvement tools and techniques may include: run charts, control charts, histograms and scattergrams to present routine quality control data plan, do, check, act (PDCA) Ishikawa fishbone diagrams and cause and effect diagrams logic tree similarity/difference analysis Pareto charts and analysis force field/strength weakness opportunities threats (SWOT) analysis Sustainable energy principles and work practices may include: examining work practices that use excessive electricity switching off equipment when not in use regularly cleaning filters insulating rooms and buildings to reduce energy use recycling and reusing materials wherever practicable minimising process waste Communication may involve: supervisors, managers and quality managers administrative, laboratory and production personnel internal/external contractors, customers and suppliers 12

14 Reporting Reporting may include: verbal responses data entry into laboratory or enterprise database brief written reports using enterprise proformas Quality improvement opportunities Quality improvement opportunities could include improved: Occupational health and safety (OHS) and environmental management requirements production processes hygiene and sanitation procedures reductions in waste and re-work laboratory layout and work flow safety procedures communication with customers methods for sampling, testing and recording data OHS and environmental management requirements: all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time all operations assume the potentially hazardous nature of samples and require standard precautions to be applied where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health 13

15 Skills and Knowledge Required skills applying problem solving techniques and strategies applying statistical analysis and statistical sampling procedures detecting non-conforming products or services in the work area documenting and reporting information about quality contributing effectively within a team to recognise and recommend improvements in productivity and quality implementing and monitoring improved practices and procedures Required knowledge specifications for laboratory products and services in the candidate's work area quality requirements associated with the individual's job function and/or work area scientific and technical knowledge underpinning the processes, procedures, equipment and instrumentation associated with the candidate's work tasks and duties workplace procedures associated with the candidate's regular technical duties sustainable energy principles relevant health, safety and environment requirements layout of the enterprise, divisions and laboratory organisational structure of the enterprise lines of communication role of laboratory services to the enterprise and customers 14