Please enable JavaScript.

Coggle requires JavaScript to display documents.

QC and QA, Training Record, R&D, QC supervisor, Product Leader -…

- - - - QC supervisor
        
        Assign
        
        QC operators
        
        If passed
        
        QC supervisor
        
        Verify and
        approve
        
        1 more item...
        
        Failed, out-of-spec
        investigation
        
        QC supervisor
        
        contact
        
        1 more item...
        
        Put retention samples from Admore
        in retention room; sign QC logbook
      - Production staff
        
        Put in-house retention samples (including PILOT BATCH) into retention room; sign QC logbook
      - Pilot batch for process changes, critical changes in formulation; non commercization ?? :warning:
        
        Product Leader
        
        review and approve result;
        
        notify QC supervisor and sign the QC worksheet
      - QC operators
        
        put TPM (such as Admore) samples into retention; sign QC logbook
  - - - QC supervisor
        
        Low-variance RM
        
        For in-house
        materials and TPM
        
        QC operators
        
        If passed
        
        QC supervisor
        
        1 more item...
        
        Save COAs in "PR-RM -Product
        Spec and COA" ;
        file QC worksheet
        
        If failed, out-of-spec
        investigation
        
        QC supervisor
        
        1 more item...
        
        High-variance RM
- - - - QC supervisor
        
        Assigned QC operators to run the validation tests. The result is passed to Product Leader for approval
        
        Product Leader
        
        Validated,
        then passed by
        
        Product Leader,
        QA manager,
        CTO
        
        File new RM Approval checklist
        
        Login thie new RM at
        Applechem Approved Raw Material List
        
        Notify QC Supervisor and Production Manager
        
        2 more items...
        
        Fail to reach
        performance
        
        Product Leader
        
        File new RM Approval checklist
        but explain the reason for not approval
        
        Notify QC supervisor/ Product manager if needed
        :warning: have a failed checklist by unifize??
        
        Conditionally
        approved??? :warning:
  - - - Oven
        
        pH meter
        
        Viscometer
        
        Scale
        
        Thermometer
    - - oversee and look for help if lab equipment is malfucntioned
  - - - Pilot Batch
        
        Set product spec;
        Issue COAs of the pilot batches when ready;
        Release products from quarantine
        
        EMAIL QC supervisor/ operators the launch
        of new products , new QC SOP existed and if Product Leader still oversees the future lots
        
        Production Manager
        
        Release products or RM
        from Quarantine
        in Fishbowl and Physical locations
        
        File approval checklist; approve RM as new RM,
        
        Customer Service
        
        Product is ready for
        customer sample request
  - - - Scan electronic copies annually
        
        Incoming RM Log book
        
        Plant Trail Log book
        
        QC Logbook
  - - - assign
        
        QC operators
        
        Remove old samples (expiration > 1 year) for products ; for new product lines, we will keep over
        
        Ensure all existing retention
        samples having COAs
        
        Record lot number with COA but no physical sample
  - - - File initial three pilot batches , approve the pilot batches
        
        Monitor and ask QC operators to perform QC tests every year
        
        notify the responsible parties about shelf life changes
- - - - File change control and
        CARA report
        
        finalize SOPs
        with
        mgt approval
        
        Update SOPs in the
        QM and corresponding
        QC or QA drive
        
        Retire SOPs in the proper folders
        
        EMAIL QC operators,
        QC supervisor and other
        corresponding parties
  - - - File change control
        
        Finalize COAs
        and product specs/
        QC SOPs/record/TDS with
        mgt approval
        
        Update COA/prod. spec templates
        in Customer Service drive
        
        Retire the old template
        
        EMAIL QC operators, QC supervisor and other
        corresponding parties
      - Finalized TDS
        with mgt approval
        
        Update TDS folder
        in Customer Service drive
        
        retired the old version of TDS
        
        Email corresponding parties
        about the change, (i.e. Customer Service)