Quality Risk Assessment SOP

Quality Risk Assessment SOP Template for Malaysia

Create a bespoke document in minutes, or upload and review your own.

4.6 / 5

4.8 / 5

Let's create your Quality Risk Assessment SOP

1. Select your governing law and document type:

2. Enter your key requirements:

3. Create your document to edit, review or download

Get your first 2 documents free

Your data doesn't train Genie's AI

You keep IP ownership of your information

Key Requirements PROMPT example:

"I need a Quality Risk Assessment SOP for our pharmaceutical manufacturing facility in Penang, Malaysia, that complies with both PIC/S guidelines and local regulations, with specific focus on cross-contamination risks in our sterile manufacturing areas to be implemented by March 2025."

Document background

The Quality Risk Assessment SOP serves as a crucial document for organizations operating within Malaysia's regulated industries, particularly those subject to GMP requirements and pharmaceutical regulations. This document is essential for establishing a systematic approach to identifying, evaluating, and controlling quality-related risks in accordance with Malaysian regulatory frameworks, including the Registration of Pharmaceuticals and Cosmetics Act 1984 and current GMP guidelines. The SOP incorporates requirements from both local regulations and international standards such as ICH Q9 and PIC/S guidelines, ensuring comprehensive risk management practices. It should be implemented when organizations need to establish or update their quality risk management systems, particularly during new product development, process changes, or in response to quality issues. The document provides detailed procedures, responsibilities, and documentation requirements necessary for effective quality risk management within the Malaysian regulatory context.

Suggested Sections

1. Purpose: Defines the objective of the SOP in establishing a systematic approach to quality risk assessment

2. Scope: Specifies the boundaries of the SOP application, including relevant processes, products, and departments

3. Definitions: Lists and explains key terms and acronyms used throughout the document

4. Responsibilities: Defines roles and responsibilities of key personnel involved in risk assessment processes

5. Risk Assessment Procedure: Details the step-by-step process for conducting quality risk assessments

6. Risk Identification: Procedures for identifying potential quality risks in processes, products, or systems

7. Risk Analysis: Methods for analyzing and evaluating identified risks, including severity and probability assessment

8. Risk Control Measures: Procedures for implementing and monitoring risk control measures

9. Documentation Requirements: Specifies required documentation and record-keeping procedures

10. Review and Monitoring: Procedures for periodic review of risk assessments and monitoring of control measures

11. Training Requirements: Specifies training requirements for personnel involved in risk assessment activities

Optional Sections

1. Risk Communication: Procedures for communicating risk-related information to stakeholders - include for complex organizations with multiple departments

2. Risk Acceptance Criteria: Detailed criteria for risk acceptance levels - include for organizations with specific risk tolerance requirements

3. Emergency Response Procedures: Procedures for handling emergency situations related to identified risks - include for high-risk operations

4. Vendor Risk Assessment: Procedures for assessing risks related to suppliers and vendors - include if external supply chain is critical

5. Computer System Validation: Risk assessment procedures specific to computerized systems - include if electronic systems are used for critical processes

Suggested Schedules

1. Risk Assessment Matrix Template: Standardized template for risk evaluation including severity and probability scales

2. Risk Assessment Form: Standard form for documenting risk assessments

3. Risk Control Plan Template: Template for documenting risk control measures and monitoring plans

4. Risk Register Template: Template for maintaining a log of identified risks and their status

5. Training Record Template: Form for documenting staff training on risk assessment procedures

6. Risk Assessment Examples: Sample risk assessments for common scenarios as reference

7. Risk Assessment Flowchart: Visual representation of the risk assessment process

8. Review Checklist: Checklist for periodic review of risk assessments

Authors

Alex Denne

Head of Growth (Open Source Law) @ ��Ƶ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co

Relevant legal definitions

Clauses

Relevant Industries

Pharmaceutical Manufacturing

Medical Devices

Biotechnology

Healthcare Products

Food and Beverage Manufacturing

Chemical Manufacturing

Contract Manufacturing Organizations

Research and Development Facilities

Clinical Research Organizations

Healthcare Facilities

Relevant Teams

Quality Assurance

Quality Control

Production

Regulatory Affairs

Manufacturing

Research and Development

Validation

Documentation

Compliance

Training

Relevant Roles

Quality Assurance Manager

Quality Control Manager

Production Manager

Regulatory Affairs Director

Compliance Officer

Quality Systems Specialist

Validation Engineer

Process Engineer

Manufacturing Supervisor

Quality Analyst

Risk Management Coordinator

GMP Compliance Manager

Quality Auditor

Documentation Specialist

Training Coordinator

Find the exact document you need

Planning And Risk Assessment In Auditing

A Malaysian-compliant audit planning and risk assessment framework aligned with local regulations and international auditing standards.

��������Ƶ

How ��������Ƶ reduced drafting time by 75% for a legal firm

Let's create your Quality Risk Assessment SOP

Authors

Alex Denne

Find the exact document you need

Planning And Risk Assessment In Auditing

Fire Risk Assessment Policy

IT Risk Assessment Matrix

Hazard And Risk Assessment Form

Field Hazard Assessment Form

Risk Assessment Policy

Client Risk Assessment Questionnaire

Risk Assessment Matrix Oil And Gas

Quality Risk Assessment SOP

Hazard Assessment Process

Risk Assessment Letter

Risk Assessment Document Software Development

Plant And Equipment Risk Management Form

Electrical Design Risk Assessment

E Signature Risk Assessment

Activity Based Risk Assessment Form Mom

Project Assessment Matrix

Risk Assessment For Grass Cutting And Strimming

Threat And Hazard Identification And Risk Assessment Guide

Supplier Security Assessment Questionnaire

Baseline Risk Assessment

Vulnerability Assessment Matrix

Method Statement And Risk Assessment For Landscaping

Hazard Identification Form

Procurement Risk Assessment Matrix

Scaffold Risk Assessment And Method Statement

Tile Manual Handling Risk Assessment

Preliminary Risk Assessment Audit

Pre Tender Risk Assessment

Compliance Risk Assessment Questionnaire

Manual Handling Risk Assessment Tool

Manual Handling Assessment Chart

Emergency Preparedness Risk Assessment

Document Control Risk Assessment

Criticality Assessment Matrix

Environmental Risk Assessment Matrix

IT Risk Assessment Policy

Generic Risk Assessment

Security Assessment Report

Risk Assessment Report

Painting Risk Assessment And Method Statement

AML Risk Assessment Report

Workplace Risk Assessment Report

Manual Handling Assessment Form

Corruption Risk Assessment And Mitigation Plan

Internal Risk Assessment Report

Fire And Life Safety Assessment Report

Site Safety Assessment Form

Third Party Risk Assessment Policy

Building Risk Assessment Report

Pre Task Risk Assessment

IT Security Risk Assessment Report

Manual Task Risk Assessment

Health And Safety Policy Risk Assessment

Fire Risk Assessment Plan

Task Specific Risk Assessment

Fire Risk Assessment Report

Activity Based Risk Assessment Form

IT Risk Assessment Report

Download our whitepaper on the future of AI in Legal

�ұ�Ծ���’s Security Promise

Your documents are private:

Your documents are protected:

Organizational security

Innovation in privacy:

Want to know more?

Use Cases

��Ƶ

How ��Ƶ reduced drafting time by 75% for a legal firm

�ұ�Ծ��’s Security Promise