Podcast
Questions and Answers
What is the primary purpose of controlling records at Compass Health?
What is the primary purpose of controlling records at Compass Health?
Which of the following best describes the scope of the record control procedure?
Which of the following best describes the scope of the record control procedure?
What does the revision history document indicate?
What does the revision history document indicate?
What aspect is NOT included in the process of record control at Compass Health?
What aspect is NOT included in the process of record control at Compass Health?
Signup and view all the answers
Which document is specifically related to the control of records as per the ISO standard?
Which document is specifically related to the control of records as per the ISO standard?
Signup and view all the answers
Which acronym represents the collection of records necessary to demonstrate that a device is manufactured according to the Device Master Record?
Which acronym represents the collection of records necessary to demonstrate that a device is manufactured according to the Device Master Record?
Signup and view all the answers
What does the term 'Life of Product' (LOP) refer to in the context of product development?
What does the term 'Life of Product' (LOP) refer to in the context of product development?
Signup and view all the answers
Which section of the ISO 13485:2016 relates to the Design and Development Files?
Which section of the ISO 13485:2016 relates to the Design and Development Files?
Signup and view all the answers
Which of the following standards specifically pertains to records in a quality system?
Which of the following standards specifically pertains to records in a quality system?
Signup and view all the answers
Study Notes
Compass Health SOP: Control of Records
- Purpose: Control of records to preserve evidence of process, quality, safety, effectiveness, and conformance with medical device requirements.
- Scope: Applies to all quality records prepared and retained by Compass Health, including those related to medical devices.
- Applicable Standards: FDA QSR § 820.180, 820.181, 820.184, 820.186; ISO 13485:2016 Section 4.2.5, 4.2.3, 7.3.10.
- Revision History: Version 1.0, Initial Release, 03-Jan-2024.
- Approvals: Tenzin Yangzom (Head of QA/RA), James Baskin (COO).
- Document Number: QMS-SOP-0003.
- Associated Documents: Document Controls SOP (QMS-SOP-0002).
Definitions and Acronyms
- DHF: Design History File
- DHR: Device History Record
- DMR: Device Master Record
- QA: Quality Assurance
- LOP: Life of Product
- QSR: Quality System Record
Design History File (DHF)
- The DHF contains records needed to demonstrate a medical device was designed according to the approved design plan and quality system requirements
- This includes dates of manufacture, quantity manufactured, released for distribution, and primary identification labeling.
Device History Record (DHR)
- The DHR demonstrates that the manufacturing process followed the device master record (DMR).
- Includes dates of manufacture, quantities manufactured and released, records that the device was manufactured according to DMR, primary device identification label and any unique identifiers used.
Device Master Record (DMR)
- Details the specifications, including drawings, composition, formulations of a medical device, component specifications, and software specifications.
Quality System Record (QSR)
- Contains records related to any quality activity. Includes forms, reports, documents, contracts and charts.
Retention Periods
- Records are to be maintained as accessible and readable.
- Quality records are kept for the lifetime of a product plus one year or 5 years whichever is longer.
Record Categorization
- Records are categorized for different purposes.
- Includes Device History File, Device Master Records, Device History Records, Medical Device Files, Quality System Records, Complaint Files, and Confidential Health Information.
Record Establishment
- Records are established by the person performing the task or activity being recorded.
- Instructions or forms for establishing records are usually found in procedures or work instructions.
Record Completion
- Only required information is recorded.
- Fields marked N/R (not required), N/A (not applicable) must have justification.
- Only authorized personnel complete and sign quality records.
Record Identification
- All records are signed and dated, and identify the person who established the record.
Indexing & Storage of Paper Records
- Records are indexed and grouped in binders, drawers, or cabinets.
- Clearly labelled with identification of contents.
- Stored in clean and dry locations with controlled temperatures.
Safeguarding of Records
- Company-controlled records are stored in DMS (Document Management System).
- Backups to prevent loss.
- Storage and management follows company procedures for each type of record.
Process Roles
- Author/Initiator: Prepares quality records.
- Document Manager: Administers the procedure and Document Management System.
- QA Specialist: Verifies compliance to the procedure, manages retention.
- QA: Verifies the retention period is correct and verifies record destruction.
Record Control Process
- All Compass Health quality records are readily accessible, well-stored and protected from deterioration.
- All Quality System Records are stored electronically and permanently, with signed copies stored when required by procedures.
Process Monitoring
- Document Manager conducts periodic reviews to ensure storage procedures are followed.
- Spot checks and assessments of the process.
- Regulatory specialist regularly reviews production records for legibility and completeness.
- Records are reviewed to ensure destruction of records occurs according to retention policies.
Disposal
- Records are destroyed after the designated retention period.
- Destruction is performed, authorized, recorded and maintained securely after review by QA.
Applicable Records
- Device Master Record: Defines the specific technical specifications for the medical device.
- Device History Record: Shows that the manufacturing process followed the DMR.
- Quality System Record: Records of quality activities.
- Medical Device File: Document containing information for medical devices.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
This quiz covers the standard operating procedures (SOP) related to the control of records at Compass Health, focusing on quality records for medical devices. It highlights relevant FDA regulations and ISO standards that govern record management, along with essential definitions and acronyms in quality assurance.
