Testing and Research Centres

A82188c990c95e331f82a4ee6d3ee837?s=47 Sigma
March 12, 2020

Testing and Research Centres

The Sigma Test and Research Centre provide testing and research facilities worldwide. Visit our website http://bit.ly/2HVkg21 and book your testing and research services. Our testing and research services rates are very cheap and our work is always quality work.

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Sigma

March 12, 2020
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  1. Sigma Test & Research Centre

  2. Cleaning & Sanitation

  3. • Daily / weekly, Master cleaning schedule for all equipments,

    general area and building. • Spring / Master cleaning frequency • Cleaning records duly signed by staff and supervisor
  4. Traceability

  5. Material Traceability • SOP for tracing Raw Material, ingredients, primary

    packaging must be laid • Each product must be traceable back and forth
  6. Product Recall

  7. • SOP must be in place for performing Product recall

    and withdrawal. • Product Recall costs 50 Billion Dollars each year worldwide • Recently, car manufacturers Toyota, General Motors, and Honda have suffered the embarrassing consequences of product recalls. In addition to the automobile industry, product recalls have also occurred in the food, medicine and consumer electronics industries.
  8. Product Coding, Return, Salvaging • Must have procedure for detailing

    the requirement of finished goods, case, carton, pallet: code and date label • Written procedure for return, receipt, storage and control of return products. • Rejected products are effectively destroyed and documented for record keeping and future reference.
  9. Pest Control

  10. • Must have SOP on pest control that takes care

    of rats, insects and birds • Inspection records to be maintained along with documentation of corrective action taken and its effects after pest control treatment • Installation of rat traps in receiving docks, entryways.
  11. • Installation of fly traps and regular cleaning of the

    equipment with documentation and operational bulbs at all times. • Installation of Air Curtains at employee entrance • Storage inside the plant must not contribute to rodent harborage
  12. Internal Audit

  13. • An Internal Audit must be held once a year.

    • There must be a Master Schedule for Internal Audit. • An Audit Manager is required to oversee the procedure. • Qualification & Training needs for the internal audit staff to be laid in black and white
  14. • Auditors need to be independent of the area where

    audit is being conducted • There must be a procedure in place to track corrective action and ensure timely follow up for the findings from the reports and same must be documented
  15. GMP / Personal Practices

  16. • Personal Protective Equipment must be worn by employees, contractors

    and visitors at all times in the site. • Proper Uniform to be worn by the staff in the designated lab. • Warning signs to be installed and clearly visible to avoid accidents. • Designated Hand Washing area and staff need to wash & dry hands before returning to work.
  17. • Employee suffering from infectious illness need to refrain from

    entering labs. • Doctor’s medical certificate stating fitness of the employee while returning to work. • Designated food storage and consumption area and need to be clean and well maintained. • No employees to be allowed to eat or drink in the lab or production area.
  18. Customer Service

  19. • A Happy Customer is a Returning Customer • Facility

    to keep & maintain Customer Service and complaint process well documented. • It includes internal communication, investigation, and timely response. • Effectively work on feedbacks to improve the services • Fact:- Very few customers complain rest never turn up again and approach our competitors instead.
  20. Supply Chain Control

  21. • There must be SOP for handling inspections, testing, and

    acceptance of incoming materials as per set specification prior to use. • Rejected materials to be controlled and stored separately from usable materials. • Non-Conforming Products:- SOP to identify, quarantine and dispose off nonconforming items to avoid accidents. • SOP for rework handling process and subsequent documentation for future reference.
  22. Raw Material & Finished Goods • Prevent deterioration of stored

    materials by monitoring 1. Physical Storage Condition. 2. Temperature. 3. Humidity. 4. Pallet Spacing. 5. Appropriate positioning to avoid cross contamination.
  23. • No raw materials to be stored outside the facility

    temporarily or permanently in containers with or without covers. • FIFO First In First Out to be maintained at all times to maintain the quality of the end product. Storage Inspections: Material area need to be routinely inspected for the storage condition, product condition, cleanliness and housekeeping and to be documented for corrective actions if need be.
  24. • Vendor Approval:- 1. Facility need to have documented Vendor

    Approval Process for raw materials, ingredients. 2. Facility need to have vendor performance evaluation system to critically analysis and assess vendors for quality and timely product delivery.
  25. Good Lab Practice

  26. Laboratory Methods • Appropriate test methods must be available for

    testing all the materials and products. • Must have specific procedure laid for handling out of specification test results. • A finished good retain sample program must be in place • All lab equipments and instruments needs to be calibrated as per the calibration schedule.
  27. • Calibration Standards are traceable to National Standards. • The

    Facility must have procedure for handling products produced with lab equipment that is found to be out of calibration. • The lab mixtures are verified regularly to ensure the validity for use. • There must be documented program to verify analyst’s proficiency.
  28. Inspection & Testing • The products needs to be tested

    as per the specifications and well documented. • Labels are examined for identity before labeling operations to avoid mix-up. • The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.
  29. Production & Process Control

  30. Process & Quality Control • SOP for the Manufacturing of

    the product. It must detail all the activities starting from issue of the raw materials till the formation of the final product. • It must include in process quality monitoring methods, frequency of checks and verification compliance • Ensure Quality checks of products are conducted by trained staff and well documented for corrective action, if any.
  31. Control of Inspection, Measuring & Test Equipment • An Identification

    system must be in place for all process equipments to know the equipments that require calibration. • Above said process needs to be well documented with the frequency of inspection. • Reference Standard needs to identified for critical test equipments. • Equipments to be calibrated against certified industry Standards. • Documentation for future reference for corrective actions, if any. •
  32. Maintenance

  33. • Facility to have SOP for Preventive Maintenance program. It

    must include a list of critical production equipment, the frequency and accountability for maintenance. • The Maintenance program must include work instructions for preventive maintenance. • The Breakdown Maintenance records to be kept for all the machines and to be reviewed time to time. • Refrain from using temporary repairs such as duct tape, or cardboard on machines.