QMS

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A Quality Management System (QMS) is defined as a set of interrelated or interacting elements such as policies, objectives, procedures, processes, and resources that are established individually or collectively to guide an organization.

In the context, organizations engaged in the storage and distribution of materials and products should establish, implement, monitor, and maintain a QMS that allows the delivery of materials, products, and services with the requisite quality and safety.

This includes ensuring the availability of resources needed to be in compliance. For this reason, each organization should define the scope of its QMS and present it in the form of a quality manual.

QMS framework for all supply chain partners that can be integrated into other management systems (e.g., environmental, occupational health, and safety)


Quality management system

Management Responsibility

  • QMS Planning
  • Communication

Documentation

  • Control of documents
  • Document categories
    • Quality manual
    • Quality policy
    • Quality Objective
    • Validation master plan
    • SOPs
    • Product specification and Material safety data sheet
    • Protocol
    • Schdules
    • Forms
    • Label
    • Labelling
  • Control of records

Resources management

  • Personnel
    • Responsibility and authority
    • Training
    • Hygiene occupational health and safety
  • Premises and equipment
  • Work environment
  • Material
  • Transportation vehicles

Operations

  • Procurement
  • Receiving / shipping
  • Sampling
  • Sales
  • Product selection and packaging
  • Transportation
  • Outsources activity

Complains Deviation Returns Recalls Counterfeit Reprocess Rework

  • Complains
  • Deviation
  • Returns 
  • Recalls 
  • Adulterant material and product
  • Counterfeit product
  • Reprocess and Rework

Monitoring and Improvement

  • Product or Services Quality reviewer
  • Audit
  • Management review
  • Corrective action / Preventive action
  • Continuous improvment

Validation

  • Commissioning and Qualification
  • Analytical method, Cleaning and process validation
  • Computerized system
  • Change control

Regulatory Affairs

Reference: GLP/000001-01

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