QMS Document Review

QMS Document Review

QMS Document Review refers to the systematic examination and evaluation of key documents that govern quality management processes within an organization. It ensures compliance with regulatory requirements, internal policies, and industry standards. The primary objectives of document review are to maintain document accuracy, effectiveness, and alignment with the organization’s quality objectives.

QMS Document Review  – Corrective and Preventive Actions (CAPA)

One of the essential documents in a QMS is the Corrective and Preventive Actions (CAPA) system. CAPA addresses the identification, investigation, and resolution of non-conformities or deviations from established quality standards. It aims to correct and prevent issues from recurring. CAPA documentation typically includes the problem description, root cause analysis, action plans, implementation details, and verification of effectiveness.

QMS Document Review  – Change Control

Change Control is another crucial document within the QMS. It ensures that changes made to processes, procedures, products, or systems are properly evaluated, authorized, communicated, and implemented. Effective change control minimizes the potential for adverse impacts on quality and ensures the organization remains compliant with regulations. Examples of change control documentation include change requests, impact assessments, approvals, and records of implementation.

QMS Document Review  –  Deviation Management

Deviation management focuses on handling instances where actual results or performances deviate from established standards or specifications. It involves identifying, assessing, documenting, and resolving deviations. Deviation management plays a vital role in maintaining product quality and process control. Deviation documentation usually comprises the description of the deviation, investigation details, impact assessment, corrective actions, and follow-up verification.

QMS Document Review

QMS Document Review  –  Market Complaint Handling

Market Complaint Handling is crucial for organizations to address customer feedback, complaints, or adverse events associated with their products or services. It involves a systematic approach to collecting, evaluating, and resolving complaints to ensure customer satisfaction and regulatory compliance. Market complaint documentation includes complaint records, investigations, root cause analysis, corrective actions, and feedback analysis.

QMS Document Review  –  Vendor Audit

Vendor Audit refers to the process of evaluating and assessing suppliers or vendors to ensure they meet the organization’s quality and regulatory requirements. Vendor audits help maintain the integrity of the supply chain and ensure the delivery of high-quality products and services. Documentation associated with vendor audits includes audit plans, checklists, audit reports, and records of corrective actions taken.

QMS Document Review  –  Frequently Asked Questions (FAQ)

Some common questions related to QMS document review:

Q1: What is the difference between corrective and preventive actions?

A. Corrective actions address existing non-conformities or deviations, aiming to eliminate the root cause and prevent recurrence. Preventive actions, on the other hand, are proactive measures taken to identify and eliminate potential issues before they occur, thereby preventing non-conformities.

Q2: How can we ensure effective change control implementation?

A. Effective change control implementation requires a well-defined process, including proper change evaluation, impact assessment, documentation, stakeholder involvement, and change validation. It is also crucial to maintain clear communication channels and ensure proper training and awareness among employees.

Q3: What are the key elements of a deviation management plan?

A. A deviation management plan typically includes a clear definition of deviation, procedures for deviation identification and documentation, investigation processes, root cause analysis techniques, corrective action and preventive action strategies, and a framework for deviation closure and review.

Q4: How should market complaints be documented and analyzed?

A. Market complaints should be documented promptly, including all relevant details, such as the complainant’s information, product details, complaint description, and any supporting evidence. The complaints should be analyzed to identify trends, potential risks, and possible corrective and preventive actions.

Q5: What factors should be considered during a vendor audit?

A. During a vendor audit, factors such as vendor qualifications, compliance with regulatory requirements, quality control processes, performance history, documentation practices, and corrective action processes should be considered. Effective communication and collaboration between the organization and the vendor are essential for successful vendor audits.


In conclusion, QMS document review plays a vital role in ensuring quality, compliance, and continuous improvement within an organization. CAPA, Change Control, Deviation, Market Complaint, and Vendor Audit are key documents that require careful review and management. By adhering to robust document review practices, organizations can enhance their processes, mitigate risks, and deliver products and services of the highest quality.

Total Quality Management (TQM): Driving Excellence and Customer Satisfaction

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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