Compass Health SOP: Control of Records

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.