API Specification Q1 Tenth Edition 4.4.3 Control of Internal Documents

The organization shall maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and this specification, including revisions, translations, and updates.

The procedure shall address:

1. responsibilities for approval and re-approval.
2. review and approval for adequacy prior to issue and use.
3. reviews for continued suitability and revisions as necessary.
4. identification of changes and current revision status.
5. legibility and identification of documents.
6. availability where the activity is being performed.

Obsolete documents shall be removed from all points of issue or use, or otherwise identified to prevent unintended use if they are retained for any purpose.
Procedures, work instructions, and forms required by the quality management system shall be controlled.

API Specification Q1 (API Q1) sets forth stringent requirements for the control of documents within the quality management system (QMS). Document control is crucial because it ensures that pertinent information is available where and when it is needed, remains secure, and is approved for accuracy and adequacy by authorized personnel. Below, we’ll explore the primary components of document control as outlined in API Q1:

Key Elements of Document Control in API Q1

1. Document Approval and Issue: Before release, documents must be reviewed and approved by authorized personnel to ensure their adequacy. This includes procedures, drawings, specifications, and instructions. It is crucial that only the current approved versions of documents are available at points of use to prevent the use of outdated or incorrect information.
2. Document Review, Update, and Re-approval: Documents must be periodically reviewed and, if necessary, updated to ensure they continue to be suitable and effective. Revisions to documents must be reviewed and approved by the same functions that performed the original review unless specifically designated otherwise. The changes must be identified in the document or the appropriate attachments.
3. Change Control: API Q1 requires a systematic approach to the management of changes. Whenever a document is revised, the nature of the revision should be identified within the document, often denoted by a revision number, date, or other marking. This helps ensure that all users are aware of changes and that the most current information is being used.
4. Document Availability: Documents must be readily available at all locations where operations essential to the effective functioning of the QMS are performed. Availability also implies that documents are legible, readily identifiable, and retrievable.
5. Document Security and Integrity: Security measures must be implemented to prevent unauthorized access to documents. Integrity of the documents must be maintained to ensure that they are not lost, damaged, or deteriorated. This is especially important for electronic documents, which require backups and protection from tampering or loss.
6. Control of External Documents: Documents of external origin necessary for the planning and operation of the QMS must be identified and their distribution controlled. This includes standards and guidelines from external bodies, customer-supplied documents, or contracts.
7. Obsolescence: Procedures must be in place to prevent the unintended use of obsolete documents, ensuring such documents are suitably marked if retained for any purpose, such as legal and knowledge preservation reasons.

Implementing Document Control in API Q1

Organizations implementing API Q1 must ensure that their document control processes are robust and efficient. Some practical steps include:

• Document Control Software: Many organizations use specialized document control software that automates many aspects of document control, including revision control, access logs, and retrieval systems.
• Training: Personnel must be trained on the document control procedures, ensuring they understand how to access and use documents appropriately, as well as how to handle revisions and obsolescence.
• Audits and Inspections: Regular audits and inspections should be conducted to ensure compliance with the document control procedures and to identify areas for improvement.

By maintaining strict control over documents, organizations can ensure that their operations are conducted according to the most current and relevant information, thereby enhancing the reliability and quality of their products and services in the oil and gas industry. This is not only a requirement of API Q1 but also a best practice in any robust quality management system.

The organization shall maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and including revisions, translations, and updates

In accordance with API Specification Q1 (API Q1) for the oil and natural gas industry, having a documented procedure for the identification, distribution, and control of documents required by the quality management system (QMS) is essential. This procedure ensures that all necessary documents are current, accessible, and properly managed throughout their lifecycle. Here’s a detailed breakdown of how an organization should approach this requirement:

1. Document Identification: Each document should have a unique identifier. This can include information such as a document number, revision number, date of issue, and page numbering. The identification system should:

• Ensure that each version of a document can be uniquely identified to prevent confusion.
• Include a history or log of document revisions to trace changes over time.

2. Document Distribution: The procedure must clearly define how documents are distributed, accessed, and utilized within the organization. Key aspects include:

• Accessibility: Ensuring that documents are accessible to those who need them to perform their duties. This could involve physical copies at specific locations or digital access through a secure network.
• Control: Establishing who is authorized to distribute documents and under what circumstances. Controls should be in place to prevent unauthorized distribution and access.
• Notification: Implementing a method to notify relevant personnel when a document is updated or revised, ensuring that everyone is working with the most current information.

3. Document Control: Document control involves several critical components to ensure that documents are accurate, reliable, and effectively managed:

• Approval and Review: Documents must be reviewed and approved for adequacy by authorized personnel prior to issue. The procedure should specify who has the authority to approve documents.
• Revisions: The process for revising documents should include how changes are proposed, reviewed, approved, and communicated. It should ensure that obsolete documents are promptly removed from all points of use or suitably marked if retained for legal or knowledge preservation purposes.
• Retention and Archiving: Define how long documents are to be retained, how they are archived, and how they are eventually disposed of if necessary. This includes ensuring that archived documents remain accessible and legible for the duration of their retention period.
• External Documents: Establish controls for the identification, storage, access, and distribution of externally created documents that are part of the QMS. This includes customer or regulatory documents.

4. Revisions: Document revisions are a critical aspect of document control. The procedure should include:

• Tracking and Recording Changes: Documenting the details of what was changed, who approved the change, and when it was made. A revision history log is useful for this purpose.
• Review and Approval: Before a document revision is implemented, it should be reviewed and approved by authorized personnel. This ensures the changes meet all necessary standards and requirements.
• Distribution and Access: Ensuring that the revised document is distributed to all relevant stakeholders and that previous versions are removed from circulation or clearly marked as obsolete to prevent unintended use.

5. Translations: If the organization operates in a multilingual environment, the document control procedure must address the translation of documents to ensure accuracy and consistency across languages. This includes:

• Accuracy of Translation: Translations must be carried out or verified by competent translators familiar with the specific technical language of the industry and QMS requirements.
• Review and Approval: Translated documents should undergo a review and approval process similar to that for original documents, potentially including a cross-verification by a native speaker to ensure the translation’s accuracy.
• Document Identification: Translated documents should be clearly identified, and their relationship to the original document should be traceable.

6. Updates: Regular updates are necessary to ensure documents remain relevant and effective. The procedure should include:

• Scheduled Reviews: Establishing a regular schedule for reviewing documents to determine if updates are needed based on new information, feedback, changes in processes, or regulatory updates.
• Responsibility for Updates: Assigning specific responsibilities for initiating, reviewing, and approving updates to ensure accountability.
• Communication: Clearly communicating updates to all affected parties promptly, ensuring that they are aware of new requirements or changes.

7. Electronic Document Management: For organizations using electronic document management systems (EDMS), additional controls may include:

• Security: Implementing security measures to prevent unauthorized access, alterations, or loss of documents.
• Backup: Regularly backing up documents as part of data continuity and recovery strategies.
• Accessibility: Ensuring that electronic documents can be accessed only by authorized personnel and are available where needed.

8. Audit and Review: The procedure should also include regular audits and reviews to:

• Verify that the document control processes are functioning as intended.
• Ensure that documents are up to date and meet the current needs of the organization.
• Address any discrepancies, non-conformities, or opportunities for improvement identified during audits or operational activities.

By maintaining a documented procedure that covers these aspects, an organization not only complies with API Q1 but also enhances its operational efficiency and reliability. Effective document control is a cornerstone of a robust QMS, ensuring that everyone in the organization has access to correct and current information essential for their work, thereby supporting consistent quality and compliance.

The procedure for control of internal documents must include the responsibilities for approval and re-approval.

In a robust quality management system (QMS), control over internal documents is critical to ensuring the consistency and integrity of operations. Part of this control involves clearly defining and documenting the responsibilities for the approval and re-approval of these documents. Here’s how organizations can structure these responsibilities effectively:

Defining Responsibilities for Approval

1. Assignment of Roles: The organization must designate specific roles or personnel responsible for approving documents. These roles typically include QMS managers, department heads, or other senior personnel who have comprehensive knowledge and understanding of the process and its impact on the QMS.
2. Criteria for Approval: The criteria upon which a document is approved should be clearly defined. This might include compliance with internal standards and procedures, regulatory compliance, technical accuracy, and alignment with organizational objectives.
3. Approval Process: The process for approval should be formally defined and might involve several steps, including initial drafting, review by stakeholders, incorporation of feedback, and final approval by authorized personnel. Each step should be documented and traceable.
4. Document Control Software: Utilizing document control software can help streamline the approval process, providing digital trails for approvals, automatic notifications for review needs, and electronic signatures.

Defining Responsibilities for Re-approval

1. Review Triggers: Establish clear triggers for when documents need to be reviewed and potentially re-approved. Triggers might include:
   • The passage of a defined time period (e.g., annually, biannually).
   • Significant changes in processes or technology.
   • Changes in compliance or regulatory requirements.
   • Feedback from audits or significant non-conformances that suggest the need for document updates.
2. Review Responsibilities: Assign responsibilities for initiating and conducting reviews. Often, the original approving authority or a designated review committee is responsible for this process. It’s important that reviewers have the requisite knowledge and authority to make decisions about document changes.
3. Update and Re-approval Process: Just like initial approval, re-approval should follow a formal process. This includes evaluating the need for changes, implementing revisions, and undergoing a final review and approval by authorized personnel. All changes should be well-documented, highlighting what was altered, why, and by whom.
4. Communication and Implementation: Once a document is re-approved, it is crucial to communicate the changes to all relevant stakeholders and ensure that the updated document replaces all older versions in use. This prevents discrepancies and confusion in operational processes.

Best Practices for Document Approval and Re-approval

• Documentation of Processes: Clearly documented processes help in maintaining consistency and traceability in document approvals and updates.
• Training and Awareness: Ensuring that all involved personnel are trained on their roles in the document control process and are aware of the importance of strict adherence to these protocols.
• Regular Audits: Conducting regular audits of the document control process to ensure compliance and identify areas for improvement.
• Feedback Mechanisms: Implementing mechanisms for collecting feedback on document utility and clarity can inform the need for revisions and re-approval.

By establishing and adhering to a clearly defined procedure for the approval and re-approval of internal documents, organizations can ensure that their operations are performed consistently and in compliance with established quality standards. This not only supports operational excellence but also upholds safety, regulatory compliance, and efficiency across all levels of the organization.

The procedure for control of internal documents must include the review and approval for adequacy prior to issue and use.

The procedure for the control of internal documents within the framework of API Specification Q1 (API Q1) is essential for maintaining the integrity and effectiveness of the quality management system (QMS). A critical aspect of this procedure is ensuring that documents undergo thorough review and approval for adequacy before they are issued and used within the organization. This process ensures that all documents are correct, complete, and suitable for their intended purpose. Here’s a detailed look at how organizations can implement these crucial steps:

Review Process

The review process is designed to ensure that documents are accurate, complete, and suitable for their intended use. Here’s what this typically involves:

1. Initial Drafting: Documents are drafted by individuals or teams with expertise relevant to the content of the document. This might include procedures, policies, manuals, and work instructions.
2. Peer Review: The draft document should first undergo a peer review process, where other knowledgeable staff members critically evaluate the content for technical accuracy, completeness, and clarity.
3. Cross-Departmental Review: For documents that impact multiple departments or processes, a cross-departmental review is necessary to ensure that all relevant perspectives are considered and that the document aligns with interdepartmental workflows.
4. Feedback Integration: Feedback from the review processes should be integrated into the document, with revisions made as necessary to address any concerns or suggestions raised.

Approval Process

After the document has been reviewed and any necessary revisions have been made, the document must be formally approved before it can be issued and used:

1. Approval Authority: The procedure should clearly define who has the authority to approve documents. This is typically senior management or designated heads of departments who have overarching responsibility for the QMS.
2. Criteria for Approval: Approval should be based on criteria that ensure the document meets all regulatory, legal, operational, and quality standards relevant to the organization. The document must also align with the organization’s objectives and practices.
3. Record of Approval: A record of approval, often including the approver’s name, date, and position, should be maintained as part of the document’s control history. In electronic document control systems, this may be managed via electronic signatures.
4. Formal Release and Distribution: Once approved, the document is formally issued and distributed according to the document control procedure. This ensures that only the most current and approved version of the document is in circulation and accessible to those who need it.

Maintaining Document Control

Ensuring ongoing control over documents involves several additional considerations:

• Controlled Access: Access to documents should be controlled to prevent unauthorized use. This includes setting permissions in electronic systems or securing physical documents in designated areas.
• Revision Control: The procedure must also specify how documents are to be revised, reviewed, and re-approved when changes are made. Each revision should be documented with a change log detailing what was changed, why, and by whom.
• Audit Trails: Maintain audit trails for document creation, revisions, and approvals. This is critical for traceability and for audits, both internal and external.
• Training and Communication: All relevant personnel should be trained on the document control procedures and be aware of how to access and use the controlled documents. Changes to documents should be communicated appropriately to ensure that all stakeholders are informed.

By rigorously adhering to these review and approval processes, organizations can ensure that their documents are adequate and suitable for supporting the operations and objectives of the QMS. This not only helps in maintaining compliance with API Q1 but also enhances the overall effectiveness and reliability of the organization’s operational processes.

The procedure for control of internal documents must include the reviews for continued suitability and revisions as necessary.

To effectively manage the control of internal documents within the framework of API Specification Q1 (API Q1), it is crucial to establish a procedure that not only covers the initial review and approval of documents but also provides for ongoing reviews to ensure continued suitability and revisions as necessary. This continuous review process helps maintain document relevance and accuracy, ensuring they meet both operational needs and compliance requirements. Here’s how organizations can implement these aspects:

Reviews for Continued Suitability

1. Regularly Scheduled Reviews: Establish a schedule for regular reviews of all documents. The frequency of reviews might be based on the criticality of the document, changes in operations, technology, or regulatory requirements. Common intervals include annually or bi-annually, but may vary based on the organization’s needs and external factors.
2. Triggered Reviews: Besides scheduled reviews, triggers such as process failures, non-conformances, internal audits, changes in compliance requirements, or feedback from stakeholders can initiate a review. This ensures that documents remain aligned with actual practices and regulatory environments.
3. Review Process: The review process should involve relevant stakeholders, including process owners, users of the documents, and quality management representatives. This comprehensive involvement ensures that all practical insights and implications are considered.
4. Documentation of Reviews: Document the outcomes of each review, noting whether the document remains suitable or requires changes. If no changes are needed, this should also be recorded to maintain a history of the document’s adequacy over time.

Revisions as Necessary

1. Identifying Changes Needed: If a review indicates that changes to a document are necessary, the specific revisions should be clearly identified. This might involve updating procedures to reflect new equipment, processes, compliance updates, or correcting errors and ambiguities.
2. Revision Process: Like the initial document creation process, revisions should follow a structured approach:
   • Drafting Revisions: Relevant experts or teams should propose changes, which are then drafted into the document.
   • Reviewing Revisions: Proposed revisions should undergo a review process similar to the initial document review, involving stakeholders who can validate the changes.
   • Approving Revisions: After review, revisions need formal approval from authorized personnel, similar to the original document approval process.
3. Change Control and Communication: Any changes to documents should be controlled and communicated effectively. This includes updating the master document, distributing the new version, and ensuring that all obsolete copies are removed from use or access. Stakeholders should be informed of the changes and their implications.
4. Training on Revised Documents: When documents undergo significant changes, training or informational sessions can help ensure that all relevant personnel understand the new procedures or information.
5. Archiving: Old versions of documents should be archived for historical and legal purposes, with clear records of what was changed and why. This can be crucial for audits and for understanding the evolution of processes over time.

Supporting Practices

• Use of Document Management Systems: Leveraging electronic document management systems (EDMS) can streamline the control, review, revision, and archiving processes. Such systems often feature automated review reminders, version control, and audit trails.
• Continuous Improvement: The document control process should itself be subject to continuous improvement. Feedback on the process should be gathered and used to make the system more efficient and effective.

By incorporating these procedures for ongoing reviews and revisions, organizations ensure their internal documents are always up to date and reflect current practices, technologies, and regulatory requirements. This not only supports operational efficiency and compliance but also contributes to the overall effectiveness and integrity of the quality management system.

The procedure for control of internal documents must include the identification of changes and current revision status.

The procedure for the control of internal documents in a quality management system (QMS), such as outlined in API Specification Q1 (API Q1), needs to meticulously manage how documents are identified, changed, and updated. Essential to this process is the capability to track changes and understand the current revision status of each document. Here’s a structured approach to effectively manage these requirements:

Identification of Changes

1. Change Log: Each document should have a change log as part of its structure. This log records all changes made to the document, including a brief description of what was changed, who made the change, and when the change was made. This log is crucial for traceability and for understanding the evolution of the document over time.
2. Clear Marking of Changes: When changes are made to a document, they should be clearly marked within the document itself. This could be through the use of revision markers, different colored text, or sidebars in electronic documents. This makes it easier for users to quickly see what has been updated since the last version.
3. Version Control Numbering: Implementing a version control system that assigns a unique identifier to each version of a document is vital. This often includes a major and minor revision number (e.g., 2.1, where 2 is the major revision and 1 is the minor revision). Major revisions might involve substantial changes, whereas minor revisions could be minor updates or corrections.
4. Document Metadata: Including metadata in documents such as the revision date, revision number, and approver’s name helps users quickly verify the document’s current revision status and ensure they are referring to the latest version.

Managing Current Revision Status

1. Centralized Document Repository: Using a centralized document management system or repository ensures that all stakeholders access the same, most current version of a document. This system should only allow the latest approved versions of documents to be visible and accessible to users, while previous versions are archived.
2. Access Controls: Implementing access controls ensures that only authorized personnel can make changes to documents. This helps maintain the integrity of the document control process and prevents unauthorized modifications.
3. Document Distribution and Withdrawal: The procedure must outline how updated documents are distributed and how obsolete versions are withdrawn. This might involve notifications to affected users, updating shared electronic directories, or physical retrieval of outdated documents.
4. Regular Audits: Conduct regular audits to ensure that the document control procedures are being followed, that the documents in use are the current versions, and that obsolete documents are not in use.

Training and Communication

• Training Programs: Train all relevant personnel on the document control procedures, emphasizing the importance of using the current revision of any document and how to identify the revision status.
• Clear Communication: Communicate changes in documents promptly to all affected stakeholders. Ensure that they understand the nature of the changes and the impact on their work processes.

Implementing these steps ensures that documents are kept up to date and that all modifications are tracked and clearly communicated. This process not only supports regulatory and internal compliance but also enhances the efficiency and effectiveness of the organization’s operations by ensuring that all personnel work from the most current and accurate documents.

The procedure for control of internal documents must include the legibility and identification of documents.

A crucial aspect of document control within a quality management system (QMS), such as the one outlined by API Specification Q1 (API Q1), is ensuring the legibility and proper identification of all internal documents. This is essential for maintaining the clarity, accessibility, and traceability of documents, which supports the effectiveness of the QMS. Here’s how to incorporate these requirements into a document control procedure:

Ensuring Legibility of Documents

1. Clear Formatting: Documents should be formatted in a clear, readable manner. Use standard fonts, headings, subheadings, and bullet points to organize information logically and make it easy to read.
2. Quality of Reproductions: Ensure that all copies of documents, whether digital or physical, maintain a high quality so that no information is lost or obscured in the reproduction process. This includes checking the quality of printed documents and the resolution of digital files.
3. Durability of Physical Documents: For physical documents, use high-quality paper and printing methods that do not fade or degrade over time. Consider environmental factors where the documents will be stored and ensure materials used are suitable for these conditions.
4. Accessibility in Different Formats: Ensure documents are accessible in formats that are suitable for all users, including those with disabilities. This might involve providing documents in large print, braille, or electronically in formats that are compatible with screen readers.

Identification of Documents

1. Unique Document Numbering: Each document should have a unique identifier or document number that distinguishes it from others. This number is crucial for filing, retrieval, and reference.
2. Title and Date: Include a clear title and the date of creation or last revision on each document. The date helps users verify they are referring to the most recent version.
3. Author and Approval Signatures: Documents should include information about the author, as well as signatures (or electronic signatures) of those who have reviewed and approved the document. This establishes accountability and approval authority.
4. Revision Status: Clearly mark the revision status on each document, typically near the title or in the footer. This includes the revision number and date of the latest revision, helping users quickly see if they are working with the latest version.
5. Document Metadata: Provide additional metadata where necessary, such as a brief description of the document’s purpose, the intended audience, and any related documents.

Managing Document Legibility and Identification

1. Standard Templates: Use standard templates for all types of documents within the organization. Templates should include predefined sections for document identification, revision information, and approval signatures. This standardization ensures consistency across all documents.
2. Electronic Document Management System (EDMS): Utilize an EDMS to manage digital documents. These systems can automate much of the identification process, ensure documents remain legible, and facilitate quick updates and accessibility.
3. Training and Guidelines: Provide training for all employees on how to manage document formatting, identification, and updating procedures. Create guidelines that detail standards for document creation and maintenance.
4. Regular Audits: Conduct regular audits to ensure documents meet legibility and identification standards. Audits can help identify documents that do not conform to the guidelines and need to be updated or reformatted.

Incorporating these measures into the document control procedure helps ensure that all documents within the QMS are easily accessible, readable, and properly managed. This not only supports compliance with API Q1 but also enhances the overall effectiveness and operational efficiency of the organization.

The procedure for control of internal documents must include the availability where the activity is being performed.

The availability of documents at the location where activities are being performed is a critical aspect of the document control procedure, particularly under the guidelines of API Specification Q1 (API Q1) which governs the quality management systems (QMS) in the petroleum and natural gas industry. Ensuring that documents are available at the point of use is crucial for maintaining operational effectiveness, ensuring compliance, and supporting consistent implementation of processes and policies. Here’s how organizations can ensure document availability as part of their document control procedures:

Strategies for Ensuring Document Availability

1. Location-Specific Document Access:
   • Physical Copies: For environments where digital access may be limited or impractical, maintain physical copies of necessary documents at the location where the activities are performed. These could include work instructions, safety manuals, or operational procedures.
   • Digital Access: In settings where technology allows, use electronic document management systems (EDMS) to provide digital access. Ensure that workstations or mobile devices are available and equipped to access these documents.
2. Centralized Document Stations:
   • Set up centralized stations (either physical filing stations or digital kiosks) where documents can be accessed easily by personnel working in particular areas. This is especially useful in large operational sites like manufacturing floors or workshops.
3. Portable Document Formats:
   • Utilize portable document formats and mobile devices to allow access in various operational environments. Tablets or handheld devices that can display documents in formats such as PDFs can be highly effective.
4. Document Accessibility in the Field:
   • For field operations, consider the use of rugged laptops or tablets that can handle environmental factors (dust, moisture, etc.). Ensure that these devices have access to the central document repository, potentially synchronized periodically where constant internet connection is not available.

Ensuring Effective Use of Documents

1. Regular Updates and Synchronization:
   • If using digital means to access documents, ensure that all devices are regularly updated to reflect the most recent versions of documents. This may involve automatic synchronization with the central document server.
   • For physical copies, establish a regular schedule for replacing outdated documents with updated versions.
2. Training and Awareness:
   • Train employees on how to access documents from different locations within the operational site. This includes training on the use of any digital devices or software involved in document access.
   • Raise awareness about the importance of using only the most current documents and how to verify the revision status of a document.
3. Document Format and Usability:
   • Ensure that documents are formatted to be easily readable and understandable in the context of their use. For instance, quick reference guides or checklists might be more useful in operational contexts than full procedural documents.
   • Consider environmental factors affecting document legibility, such as lighting conditions, when designing document formats and deployment strategies.
4. Audits and Feedback:
   • Regularly audit the availability and usage of documents at the point of use to identify any gaps in accessibility or issues with document formats.
   • Gather feedback from users on the effectiveness of the document availability strategy and make adjustments as necessary.

By integrating these strategies into the document control procedure, organizations can ensure that all necessary documents are available at the location where activities are being performed, thereby supporting efficient operations, compliance, and the overall effectiveness of the QMS. This aligns with the requirements of API Q1 and is essential for maintaining high standards of quality and safety in the petroleum and natural gas industry.

Document Control Procedure Example

1. Scope This procedure applies to all quality-related documents generated within the organization, including manuals, policies, procedures, work instructions, and records.

2. Purpose To ensure that all documents related to the QMS are controlled with regard to approval, revision, distribution, and accessibility, ensuring compliance with API Q1 standards.

3. Responsibilities

• Quality Manager: Oversees the document control system, approves documents, and ensures compliance with API Q1.
• Document Control Specialist: Manages the day-to-day operations of document control, including distribution, archiving, and retrieval of documents.
• Department Heads: Review and approve department-specific documents and ensure that their team members have access to the latest versions.
• IT Department: Supports the electronic document management system, ensuring system security, accessibility, and data integrity.

4. Procedure

4.1 Creation and Identification

• Documents are created by the relevant department under the guidance of the Department Head.
• Each document must have a unique identifier (document number), title, date, and author.

4.2 Review and Approval

• Draft documents are reviewed by the relevant department team and revised as necessary.
• Final draft is sent to the Quality Manager for approval.
• Documents are approved through signatures or electronic approval by designated authorities.

4.3 Distribution and Accessibility

• Approved documents are made available in the document management system with controlled access settings to ensure only authorized personnel can view or edit them.
• Physical copies, if required, are distributed to designated locations and logged in a distribution register.

4.4 Revision and Update

• Documents are reviewed annually or as triggered by process changes, non-conformities, or external requirements.
• Revisions are initiated by the document author, reviewed by the Department Head, and approved by the Quality Manager.
• Changes are documented in a revision log within the document, detailing the nature of the change, the author, and the approval date.

4.5 Archiving and Retention

• Obsolete documents are promptly removed from active use and distribution.
• Electronic copies of obsolete documents are archived in the document management system with restricted access.
• Physical copies are marked as obsolete and moved to a secure storage area.
• Document retention periods are determined based on legal and regulatory requirements.

4.6 Training

• All employees are trained on how to access and use the document control system upon induction and whenever significant changes to the document control process are made.
• Regular refresher training sessions are conducted to ensure ongoing compliance and awareness.

5. Monitoring and Review

• The effectiveness of the document control procedure is monitored through internal audits and management reviews.
• Feedback from these audits and reviews is used to make continuous improvements to the procedure.