Laboratory Administration & Management of Pathology Practices
Inspection and accreditation processes
Document and procedure management
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Last author update: 7 November 2024
Last staff update: 7 November 2024
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PubMed Search: Document and procedure management
Table of Contents
Definition / general | Essential features | Terminology | Diagrams / tables | Procedure life cycle | Document control | Videos | Additional references | Board review style question #1 | Board review style answer #1 | Board review style question #2 | Board review style answer #2Cite this page: Ahsan M, Hassell LA. Document and procedure management. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/managementlabdocumentprocedure.html. Accessed December 4th, 2024.
Definition / general
- Document management is one of the essential elements of the quality management system (QMS) that ensures easy accessibility, reliability and safety of information
- Main purpose of keeping records and documents is to find information whenever needed
Essential features
- Document and procedure management is one of the 12 essential elements of the quality management system (QMS)
- In the management system, documents and records are managed both in terms of their use and maintenance
- Main purpose of keeping records and documents is to find information when it is needed
- Document refers to all the written policies, processes and procedures of the organization as well as forms, checklists or other tools in use to manage processes
- Document control systems help maintain and format documents
- Quality manuals, standard operating procedures (SOPs), job aids and procedure manuals are some examples of documents
Terminology
- Document: information sources and supporting media are referred to as documents
- Procedure: detailed instructions describing a specific method to perform; standard operating procedures (SOPs) are detailed instructions on how to conduct a particular task
- Policy: an overall intention endorsed by management and chosen from alternative options to guide future decisions
- Process: the steps involved in implementing quality policies; it is the transformation of inputs into outputs through the coordination of interrelated or interdependent activities
- Work aid: a procedure or a portion of a procedure, created to serve as a reference while the worker performs the task
- Form: a blank document used to record performance results
- Record: a document containing results or other critical information about a project performance of a procedure
- Quality manual: a document that explains how an organization maintains its quality management system
- As part of QMS model, document management is one among other quality system essentials (QSE), including the following (Whitehat: Quality Management - Making it Meaningful [Accessed 23 October 2024])
- Organization
- Personnel
- Equipment
- Purchasing and inventory
- Process control
- Information management
- Documents and records
- Occurrence management
- Assessment
- Process improvement
- Customer service
- Facilities and safety
Diagrams / tables
Procedure life cycle
- There are several processes involved in the life cycle of a procedure (see Diagram 1), including
- Writing and developing new procedures
- Editorial review and approval
- Deployment and making accessible for training
- Review and maintenance of procedures
- Taking documents out of the system (retiring / archiving)
- Reference: CAP: CAP Document Control Course - Sample Content [Accessed 23 October 2024]
Document control
- Document control involves a set of processes that govern the management of documents, including
- Creation and development of new documents
- Approval for adequacy
- Maintenance, storage and availability of documents for use
- Modifications, revisions and reissues
- Taking documents out of the system and archiving
- Purpose of document control (J Med Biochem 2017;36:231)
- Keeping the most current version of the document or procedure
- Ensuring that documents and procedures are accessible, user friendly and deemed adequate
- Managing the archive of documents and removing outdated versions from circulation
- Risks associated with the lack of document control include
- Misuse of documents
- Variation from defined procedures leading to inaccurate results, patient harm, economic losses, etc.
- Failure to uniformly document key data (quality control [QC], etc.)
- Lack of accessibility to documents
- Document types that must be controlled in a QMS include
- Documents related to the laboratory workflow
- Documents that provide instructions on how to perform specific tasks
- Documents guiding policy decisions
- Documents describing how the quality management system is structured
- Reference documents that provide technical or scientific information
- Lists, registries and logs of documents
- Documents that outline the policies and requirements for a regulatory or legal framework
- Hierarchy of laboratory documents (see Diagram 2) is as follows (Clin Biochem 2009;42:279)
- Quality manual
- Policies
- Processes
- Procedures, records, work aids / instructions and forms
- Elements of document control system include
- Format that is uniform, including a numbering system, so that the document can be identified according to its version (date)
- Formal approval process for new documents, distribution plans and distribution lists and a procedure for updates and revisions to laboratory documents
- Master list of the laboratory documents or an inventory
- Processes to ensure that the documents are available to all who need them, including users outside the laboratory
- Assuring that the documents are easily accessible at appropriate times and places
- Retaining and archiving outdated documents for future reference even though they are outdated
- Storage, maintenance and archiving of documents must take into account the following factors
- Permanence (backup systems and availability in various disaster scenarios)
- Security (access controls)
- Editing controls
- Traceability
- Tools for document storage, maintenance and archiving include
- Historical paper system for records
- Shared electronic documents
- Other documents beyond procedures and policies that merit inclusion in a document management system
- QC charts
- Flow diagrams / if - then decision trees or troubleshooting tools
- Maintenance records
- Contracts
- Employee records
- Safety records (Facilities and safety)
- Reference: CAP: CAP Document Control Course - Sample Content [Accessed 23 October 2024]
Videos
Document control
Document control according to ISO 9001
Additional references
Board review style question #1
MEDcare Lab is considering migrating from paper based procedures to an online shared documentation system for all their procedures and quality data. Which of the following questions must be included in their request for proposal to potential vendors?
- Does the system allow access to nonorganizational individuals or entities for special purposes such as accreditation inspections?
- Does the system allow all administrators to edit any or all documents?
- Does the system have a means of access when network, power or computer system failures have occurred?
- Does the system track read only access to the documents?
Board review style answer #1
C. Does the system have a means of access when network, power or computer system failures have occurred? Access to procedures must be available at all times when laboratory testing is being conducted. While certain disasters might preclude the ability to perform testing, halting testing for a server or network fault could be disastrous. Answer A is incorrect because while access to procedures by inspection personnel is desirable, it is not a critical determinate for functionality since such access can be facilitated in other ways. Answer B is incorrect because not all administrators should be given control over all documents; rather, editorial control should be tailored according to specific requirements and expertise. Answer D is incorrect because read only access is not a critical functionality requiring control or tracking to maintain security. Education and familiarity with procedures can be documented via other means.
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Reference: Document and procedure management
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Reference: Document and procedure management
Board review style question #2
Which of the following pairs are essential parts of a quality management system (QMS)?
- Document control and root cause analysis
- Lab space and process improvement
- Personnel records and document control measures
- Six Sigma methodology and competency assessments
- Vision statement and employee engagement
Board review style answer #2
C. Personnel records and document control measures; both are essential elements of a QMS. Answer A is incorrect because root cause analysis is not an essential component of QMS but may be employed as a part of incident management as needed. Answer B is incorrect because lab space is not an explicit part of a QMS. Answer D is incorrect because Six Sigma is only one of several types of process improvement tools that can be used, while competency assessment is one part of employee records that would be important in a QMS. Answer E is incorrect because a vision statement and employee engagement may or may not be useful in defining an organization and creating a healthy culture but are not explicit components of the QMS.
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Reference: Document and procedure management
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Reference: Document and procedure management
