Process Establishment Framework ( P2P )

To ensure operational excellence and regulatory alignment, the following structured approach is recommended:

 

Analyze Business Nature and Applicable Processes

• Conduct a comprehensive study of the organization's core activities, industry standards, and regulatory environment.
• Identify key operational domains (e.g., procurement, manufacturing, quality control, finance, customer service).
• Map existing workflows and assess gaps or inefficiencies.

 

Develop Standard Operating Procedures (SOPs)

• Create detailed SOPs for each critical process, ensuring consistency, traceability, and compliance.
• Include roles and responsibilities, step-by-step execution, escalation paths, and documentation requirements.
• Align SOPs with industry best practices and applicable standards (e.g., ISO, GMP, AS9100).

 

Define Organizational Policies

• Establish policies governing procurement, quality assurance, data management, compliance, and risk mitigation.
• Ensure policies reflect strategic priorities, legal obligations, and ethical standards.
• Communicate policies across departments and integrate into training programs.

 

Evaluate and Select Appropriate IT Systems

• Assess the need for digital tools to support process automation, data integrity, and scalability.
• Identify suitable ERP, MES, QMS, or inventory platforms based on business size, complexity, and integration needs.
• Ensure systems support audit trails, role-based access, and real-time analytics.

 

Define Master Data and Transactional Data Requirements

• Master Data: Establish foundational datasets such as vendor master, item master, BOMs, customer master, and chart of accounts.
• Transactional Data: Define data generated through operations—purchase orders, invoices, production records, quality logs, etc.
• Implement data governance protocols to ensure accuracy, consistency, and security.