Procedures - Quality Management System

Procedures are documented ways of carrying out activities within a quality management system. They provide detailed instructions, assign responsibilities, and ensure consistency in operations across the organization.

Procedure Structure

A well-structured procedure clearly defines what needs to be done, who is responsible, and how the activity should be performed, ensuring consistency and quality in execution.

Essential Components

  • Purpose and scope definition
  • Roles and responsibilities
  • Required resources and tools
  • Step-by-step instructions
  • Quality criteria and checks

Types of Procedures

  • System Procedures: Document control, internal audits, management review
  • Operational Procedures: Production, quality control, maintenance
  • Support Procedures: Training, purchasing, customer service

Writing Guidelines

  • Use clear, simple language that is easy to understand
  • Follow a standardized format for consistency
  • Include visual aids when helpful (flowcharts, diagrams)
  • Define technical terms and abbreviations
  • Use active voice and direct instructions
  • Number steps sequentially for clarity
  • Highlight critical points and warnings

Development Process

  • Process analysis and mapping
  • Stakeholder consultation
  • Draft preparation
  • Review and feedback
  • Revision and refinement
  • Approval and implementation

Implementation Steps

  • Training program development
  • Pilot testing phase
  • User feedback collection
  • Procedure refinement
  • Full deployment
  • Performance monitoring

Common Procedure Issues

  • Overly complex or technical language
  • Missing or unclear steps
  • Ambiguous responsibilities
  • Outdated information
  • Poor formatting and organization
  • Lack of practical examples
  • Inconsistent terminology

Best Practices

Development

  • Involve end users in creation
  • Use standard templates
  • Include visual aids
  • Conduct thorough testing

Implementation

  • Provide comprehensive training
  • Monitor compliance regularly
  • Collect user feedback
  • Update as needed

Maintenance

  • Schedule regular reviews
  • Maintain version control
  • Manage changes effectively
  • Monitor performance

Review and Validation

Content Review

  • Technical accuracy check
  • Completeness verification
  • Clarity assessment
  • Consistency evaluation

Usability Testing

  • User acceptance testing
  • Practical application
  • Efficiency measurement
  • Effectiveness validation