SAQA All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.
SOUTH AFRICAN QUALIFICATIONS AUTHORITY 
REGISTERED UNIT STANDARD: 

Maintain the integrity of a sensitive manufacturing environment 
SAQA US ID UNIT STANDARD TITLE
246478  Maintain the integrity of a sensitive manufacturing environment 
ORIGINATOR
Chemical Industries SGB 
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY
-  
FIELD SUBFIELD
Field 06 - Manufacturing, Engineering and Technology Engineering and Related Design 
ABET BAND UNIT STANDARD TYPE PRE-2009 NQF LEVEL NQF LEVEL CREDITS
Undefined  Regular  Level 2  NQF Level 02 
REGISTRATION STATUS REGISTRATION START DATE REGISTRATION END DATE SAQA DECISION NUMBER
Reregistered  2018-07-01  2023-06-30  SAQA 06120/18 
LAST DATE FOR ENROLMENT LAST DATE FOR ACHIEVEMENT
2024-06-30   2027-06-30  

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.  

This unit standard does not replace any other unit standard and is not replaced by any other unit standard. 

PURPOSE OF THE UNIT STANDARD 
Learners who demonstrate competence as described in the outcomes of this unit standard will demonstrate understanding of, and be able to prevent or minimise the effect of contamination in a sensitive manufacturing environment. The typical context of this unit standard covers manufacturing operations within a pharmaceutical, food and beverage related or personal care products environment.

The qualifying learner is able to:
  • Apply general health and hygiene procedures applicable to a sensitive manufacturing environment.
  • Apply environmental monitoring and control procedures applicable to a sensitive manufacturing environment.
  • Apply internal and external contamination control procedures applicable to a sensitive manufacturing environment.
  • Apply aseptic techniques during the handling and storage of materials. 

  • LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING 
    Learners accessing this unit standard will have demonstrated competence against numeracy and literacy at NQF Level 1 or equivalent. 

    UNIT STANDARD RANGE 
  • The typical context of this unit standard covers the production of pharmaceuticals, some FMCGs, beverages and fruit juices, dairy products and personal care products.
  • Range statements, which are applicable to the unit standard titles, specific outcomes and assessment criteria are found beneath the applicable assessment criteria. 

  • Specific Outcomes and Assessment Criteria: 

    SPECIFIC OUTCOME 1 
    Apply general health and hygiene procedures applicable to a sensitive manufacturing environment. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The basic health and safety requirements pertaining to the pharmaceutical- and personal care products industries are explained with reference to relevant legislation and regulations. 
    ASSESSMENT CRITERION RANGE 
  • Regulatory framework includes Medicines and Related Substances Control Act and the Foodstuffs, Cosmetics and Disinfectants Act and the OHS Act.
  • Differences between the requirements for various classes of products are highlighted.
     

  • ASSESSMENT CRITERION 2 
    The reasons for maintaining a clean manufacturing environment are explained in terms of the impact on the products manufactured and the consequences of not adhering to these requirements. 
    ASSESSMENT CRITERION RANGE 
    Consequences include but are not limited to the effect on the health and safety of self and others, contamination of equipment and the environment, as well as jeopardising regulatory compliance and product quality.
     

    ASSESSMENT CRITERION 3 
    The importance of adhering to health, hygiene, dress code and personal protective equipment (PPE) policies and procedures is described in terms of the consequences that may result from any procedural deviation. 
    ASSESSMENT CRITERION RANGE 
    Consequences include own safety, safety of fellow workers, safety of clients, equipment, environment, product quality, productivity and the possible legal consequences to self and the company.
     

    ASSESSMENT CRITERION 4 
    Correct dress code and PPE requirements for all operating situations are described and adhered to in accordance with company policies and procedures. 

    ASSESSMENT CRITERION 5 
    All personal health and hygiene requirements are described and adhered to in accordance to company policies and procedures. 

    SPECIFIC OUTCOME 2 
    Apply environmental monitoring and control procedures applicable to a sensitive manufacturing environment. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    Different types of micro organisms that may cause contamination are identified using applicable scientific terminology. 
    ASSESSMENT CRITERION RANGE 
  • Micro organisms are identified from sketches, photographs or under a microscope.
  • Gram negative and positive micro organisms are identified.
     

  • ASSESSMENT CRITERION 2 
    Micro organisms that may cause contamination are described using applicable scientific terminology. 
    ASSESSMENT CRITERION RANGE 
    Descriptions include their types, origins, distribution methods, growth conditions, growth rate, potential hazards and applicable decontamination methods.
     

    ASSESSMENT CRITERION 3 
    An environmental monitoring and control system is explained in terms of its role in maintaining the overall integrity of a sensitive system and the process of contamination monitoring, prevention and -containment. 

    ASSESSMENT CRITERION 4 
    Environmental monitoring and control procedures are applied and maintained in a sensitive workplace environment according to SOPs and legal requirements. 
    ASSESSMENT CRITERION RANGE 
  • Environmental monitoring procedures should include but are not limited to air, fallout, surface and personal monitoring and control.
  • Environmental control procedures should include but are not limited to cleaning, sanitisation and disinfection.
     

  • SPECIFIC OUTCOME 3 
    Apply internal and external contamination control procedures applicable to a sensitive manufacturing environment. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The impact of the external environment on product quality is described in terms of the different variables, the systems linking them to the workplace and possible protection mechanisms. 
    ASSESSMENT CRITERION RANGE 
  • Variables should include but are not limited to temperature, air pressure, humidity, rain and wind/air movement.
  • Linking systems should include but are not limited to air conditioning, ventilation, heating and water handling systems.
     

  • ASSESSMENT CRITERION 2 
    Protection mechanisms and procedures employed to minimise the impact of the external environment in a sensitive environment are described in terms of their basic operating principles. 

    ASSESSMENT CRITERION 3 
    The impact of the internal environment on product quality is described in terms of the mechanism in which these internal factors may contribute to contamination. 
    ASSESSMENT CRITERION RANGE 
    Contributing factors should include but are not limited to lighting, security, safety, housekeeping, eating, drinking, smoking, waste-disposal, pest-control, maintenance activities, general cleanliness and people movement.
     

    ASSESSMENT CRITERION 4 
    The prevention of contamination due to internal factors is described in terms of those standard operating procedures used to prevent or minimise the risk of contamination. 

    SPECIFIC OUTCOME 4 
    Apply aseptic techniques during the handling and storage of materials. 

    ASSESSMENT CRITERIA
     

    ASSESSMENT CRITERION 1 
    The importance of maintaining material and product integrity is explained in terms of its potential impact on people, products and the environment. 

    ASSESSMENT CRITERION 2 
    Descriptions are provided of the possible contamination mechanisms which materials and products may be subjected to during storage and handling, based on industry examples and case studies. 

    ASSESSMENT CRITERION 3 
    All handling and storage procedures to maintain material and product integrity are described and adhered to as indicated by SOPs, signage, labels and documentation. 
    ASSESSMENT CRITERION RANGE 
    Procedures should include but are not limited to performing batch separations, maintaining material identification, storage security and -conditions and controlling material flow, handling and exposure.
     

    ASSESSMENT CRITERION 4 
    Material and product status conditions are defined and verified as per industry standards and company SOPs. 
    ASSESSMENT CRITERION RANGE 
    Status can imply any of the following:
  • Quarantined on-hold/frozen.
  • Released/approved/saleable.
  • Rejected.
     

  • ASSESSMENT CRITERION 5 
    Relevant aseptic documentation is completed as per SOPs and regulatory requirements. 


    UNIT STANDARD ACCREDITATION AND MODERATION OPTIONS 
  • An assessor, accredited with a relevant NQF Level 2 or higher qualification, will assess the learner's competency.
  • Anyone assessing a learner or moderating the assessment of a learner against this Unit Standard must be registered as an assessor with the relevant ETQA.
  • Direct observation in simulated or actual work conditions is required. 

  • UNIT STANDARD ESSENTIAL EMBEDDED KNOWLEDGE 
    Qualifying learners understand and can:

    Explain the names, functions and locations of:
  • All items of installed equipment
  • Raw materials.
  • Finished products.

    Describe the properties and characteristics of:
  • Raw materials.
  • Products.
  • Process equipment.

    Explain the purpose of the:
  • Process, in terms of product/s, efficiencies and quality.

    Explain the causes, effects and implications of:
  • Process variables.
  • Raw material variables (suppliers).
  • Product variables (customers).
  • Hazards.
  • Not complying with safety standards.
  • Not complying with standard operating procedures.
  • Not complying with quality specifications.

    Demonstrate procedures and techniques of:
  • Standard Operating for the starting up, monitoring, controlling and shutting down of the process.
  • Recording and reporting data.

    Explain the regulations, legislation, agreements and policies related to:
  • Occupational Health and Safety Act.
  • Environmental issues.
  • Housekeeping.
  • Company Safety Procedures.
  • Standard Operating procedures.
  • Quality specifications.
  • Hazardous Substances.
  • Foodstuffs, Cosmetics and Disinfectants.
  • Medicines and Related Substances.
  • Explosives.
  • Agricultural Products. 

  • UNIT STANDARD DEVELOPMENTAL OUTCOME 
    N/A 

    UNIT STANDARD LINKAGES 
    N/A 


    Critical Cross-field Outcomes (CCFO): 

    UNIT STANDARD CCFO IDENTIFYING 
    The learner is able to identify and solve problems in which responses display that responsible decisions, using critical and creative thinking, have been made by:
  • Identifying internal and external contamination and applying suitable corrective measures.

    Refer to the following Specific Outcome(s):
  • Apply environmental monitoring and control procedures applicable to a sensitive manufacturing environment.
  • Apply internal and external contamination control procedures applicable to a sensitive manufacturing environment. 

  • UNIT STANDARD CCFO WORKING 
    Work effectively with others as a member of a team, group, organisation or community by:
  • Maintaining sound relations with co-workers while maintaining system integrity.
  • Ensuring own and co-workers' safety.

    Refer to all Specific Outcomes. 

  • UNIT STANDARD CCFO ORGANISING 
    The learner is able to organise and manage himself and his activities responsibly and effectively by:
  • Systematic implementation of procedures to maintain system integrity.

    Refer to all Specific Outcomes. 

  • UNIT STANDARD CCFO COLLECTING 
    The learner is able to organise and manage himself and his activities responsibly and effectively by:
  • Systematic implementation of procedures to maintain system integrity.

    Refer to the following Specific Outcome(s):
  • Apply environmental monitoring and control procedures applicable to a sensitive manufacturing environment.
  • Apply aseptic techniques during the handling and storage of materials. 

  • UNIT STANDARD CCFO COMMUNICATING 
    Communicate effectively by using mathematical and/or language skills in the modes of oral and/or written presentations during:
  • Documentation of system status.

    Refer to the following Specific Outcome(s):
  • Apply aseptic techniques during the handling and storage of materials. 

  • UNIT STANDARD CCFO SCIENCE 
    Contribute to the full personal development of each learner and the social and economic development of the society at large by:
  • Identification and description of different micro organisms.

    Refer to the following Specific Outcome(s):
  • Apply environmental monitoring and control procedures applicable to a sensitive manufacturing environment. 

  • UNIT STANDARD CCFO DEMONSTRATING 
    Demonstrate an understanding of the world as a set of related systems by:
  • Explaining the impact of various types of contamination on the final product and clients.

    Refer to all Specific Outcomes. 

  • UNIT STANDARD CCFO CONTRIBUTING 
    Contribute to the full personal development of each learner and the social and economic development of the society at large by:
  • Spreading hygiene and sanitary principles when handling sensitive products in own community.

    Refer to all Specific Outcomes. 

  • UNIT STANDARD ASSESSOR CRITERIA 
    N/A 

    REREGISTRATION HISTORY 
    As per the SAQA Board decision/s at that time, this unit standard was Reregistered in 2012; 2015. 

    UNIT STANDARD NOTES 
    N/A 

    QUALIFICATIONS UTILISING THIS UNIT STANDARD: 
      ID QUALIFICATION TITLE PRE-2009 NQF LEVEL NQF LEVEL STATUS END DATE PRIMARY OR DELEGATED QA FUNCTIONARY
    Elective  58955   National Certificate: Chemical Manufacturing  Level 2  NQF Level 02  Reregistered  2023-06-30  CHIETA 


    PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS UNIT STANDARD: 
    This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.
     
    NONE 



    All qualifications and part qualifications registered on the National Qualifications Framework are public property. Thus the only payment that can be made for them is for service and reproduction. It is illegal to sell this material for profit. If the material is reproduced or quoted, the South African Qualifications Authority (SAQA) should be acknowledged as the source.