ZOLL Number: 90E0004 Page 5 of 15 1. INTRODUCTION 1.1 Purpose 1.2 Scope The purpose of this document is to provide guidance regarding the identification of a quality record and the documentation practices required for their proper creation and maintenance. These procedures apply to all documents related to the training of personnel and / or the design, testing (clinical and non-clinical), quality control, quality assurance, production, tracking, storage, service and distribution of ZOLL, medical devices. These procedures explain the manner in which data and / or information is recorded, transcribed, reviewed, transmitted and archived by ZOLL, personnel. (See also 90A0001, ation.) 2. RESPONSIBILITIES 2.1 All ZOLL, personnel are responsible for recording and storing training, design, clinical research, quality control, quality assurance, manufacturing, component and device tracking, storage, service and distribution information, as it is generated, in accordance with this document. 2.2 Each employee is responsible for ensuring the quality records he/she produces are accurate and complete. 2.3 Each department manager is responsible for ensuring their subordinates are adequately trained in the proper completion and maintenance of quality records. Department managers are responsible for ensuring quality records are maintained in accordance with the Quality Records Matrix (see Appendix A). 2.4 Quality Assurance is responsible for assisting in the identification of document or electronic files that are required in order to demonstrate: (1) conformance to specified internal or external requirements and (2) the effective operation of the quality system. 3. APPLICABLE DOCUMENTS 21 CFR Part 11 Electronic Records and Electronic Signatures 21 CFR Part 803 Medical Device Reporting (MDR) 21 CFR Part 806 Medical Devices: Reports of Corrections and Removals 21 CFR Part 820 Quality System Regulation 93/42/EEC Council Directive Concerning Medical Devices Proprietary ZOLL
ZOLL Number: 90E0004 Page 6 of 15 MEDDEV 2.12/1 March 2012 - rev.7 Commission of the European Communities Guidelines on a Medical Device Vigilance System 90A0001 90A0023 90A0127 ation Change Requests and Change Orders Electronic Records Back-up and Archival 4. DEFINITIONS 4.1 Quality Record-- A document or electronic file that is maintained to demonstrate: (1) conformance to specified internal or external requirements and (2) the effective operation of the quality system. Quality Records can include databases relevant to the above. 4.2 s identified as Quality Records include the following and their specified subparts (see relevant SOPs): Management Reviews (CONFIDENTIAL) Quality System Record Corrective Action Requests Supplier Evaluations (CONFIDENTIAL) Inspection and Nonconformance Reports Dock to Stock List Audit Reports (CONFIDENTIAL) Design Review Records Design History Files (DHF) Device Master Records (DMR) Technical Files Device History Records (DHR) Purchase Orders Equipment Maintenance Records Calibration Records Material Review Board Records Approved Supplier Lists Employee Training Records Complaint Report Forms Functional Test Reports System Problem Reports Change Requests & Change Orders Medical Device Tracking Missing Data Log Proprietary ZOLL
ZOLL Number: 90E0004 Page 7 of 15 5. PROCEDURE 5.1 General 5.1.1 Record all information directly, promptly and legibly using permanent ink, preferably BLACK ink. (Do not use felt-tipped pens.) 5.1.2 All documentation must be dated with the date on which the entry was made. DO NOT BACK-DATE AN ENTRY. 5.1.3 Data should be recorded using clear concise language, initialed, then dated in such a manner as to avoid any doubt as to when or by whom the entry was made. 5.1.4 Data entry should be recorded by the individual performing the activity 5.1.4.1 If a signature or date was omitted and employee is available, the employee who performed the work should sign with the current date and record a reason for the omission including the date on which the work was performed. 5.1.4.2 If a signature or date was omitted and employee is unable or unavailable, the employee s Manager/Supervisor will have signature authority. Manager/Supervisor shall sign with the current date & structure Manager Name signing for Employee name. 5.2 Signatures on Quality Records: 5.2.1 Quality Records may be signed using either handwritten signatures or electronic signatures. All electronic signatures must be compliant to 21 CFR Part 11. 5.2.2 All signatures, both handwritten and electronic, are legally binding. Upon request, one may be required to provide additional testimony that a specific electronic signature is the legally binding equivalent of the signer s handwritten signature. 5.2.3 Repetitious entries in a column may be completed by entering the data on the first and last row of the column and drawing an arrow from the first row to the last. See Example 1. Proprietary ZOLL
ZOLL Number: 90E0004 Page 8 of 15 Example 1: 5.3 Time and Dates Example 2: 5.3.1 Record all times in standard 12 hour format, such as 1:00 pm 5.3.2 Dates should be recorded as month day year, unless otherwise specified by a written procedure, instruction, or regulation for a specific form or label. Any reasonably apparent format or structure is acceptable. See Example 2 for commonly used formats. 2-9-15, 02-09-15, 02-09-2015, 2/9/15, 02/09/15, February 9, 2015 5.3.3 To avoid confusion, communication intended for Europe should use the format Year Month Day only, unless otherwise mandated by regulation for completion of a specific form or label. 5.4 Responding to Requested Information 5.4.1 When filling out forms and other documents that request information, respond to all requests. Do not leave blank spaces. The following should be used: 5.4.2 If the request does not apply, enter N/A, Not Applicable, in the blank space. Proprietary ZOLL
ZOLL Number: 90E0004 Page 9 of 15 5.4.3 If the information requested is unavailable but may be obtained later, enter N/I, No Information, in the blank space 5.4.4 If the information requested is not known and not obtainable, enter UNK, Unknown, in the blank space 5.4.5 If the information requested is not obtained, or an activity is not carried out, enter N/D, Not Done, in the blank space. An explanation of why the data was not obtained should be noted. 5.4.6 Entire blank pages or the unused portion of a page can be marked diagonally with a line, reason for unused space and date and initials. 5.5 Error Correction: Example 3: 5.5.1 Any change to a quality record should include a justification for the change (if not readily apparent) then be initialed and dated. See Example 3 5.5.2 To correct an incorrect entry: Example 4: 5.5.2.1 Draw a single line through the incorrect entry. Clearly enter the correct information adjacent to the error then initial and date the corrected entry. See Example 4 Example 5: 5.5.2.2 DO NOT use a liquid correcting fluid (e.g., White-out). See Example 5 Proprietary ZOLL
ZOLL Number: 90E0004 Page 10 of 15 Example 6: 5.5.2.3 DO NOT obliterate the original entry by crossing through it more than once. See Example 6 Example 7: 5.5.2.4 DO NOT write over previously entered information. See Example 7. 5.5.3 To correct an incorrectly checked box: 5.5.3.1 Circle the correct box and the associated words, draw a line through the incorrectly checked box and the associated words, then initial and date the correction, See Example 8. 5.5.3.2 DO NOT individually circle the box or associated wording as seen in Examples 9. Proprietary ZOLL
ZOLL Number: 90E0004 Page 11 of 15 Example 8: Correct- Line out and circle associated words and box. Example 9: Incorrect- Individually lined out and circled words. 5.6 Alterations of Forms 5.6.1 Alterations of led Forms, Standard Operating Procedures, Test Methods must be justified, approved and documented according to 90A0023- Change Request and Change Orders. 5.7 Storage: (General) 5.7.1 Quality Records are stored at the ZOLL facility (121 Gamma Drive, Pittsburgh, PA 15238) in such a manner as to maintain accessibility and prevent deterioration by environmental influences and loss. Records may be stored off-site in secured, environmentally protected facilities in accordance with 90A0001 ation. Quality Records intended for offsite storage shall be boxed, clearly labeled, and stored in a designated area. Records stored off-site shall be readily retrievable for review and duplication by the FDA. 5.7.2 Where possible, paper files will be stored in metal file cabinets to prevent deterioration or loss. 5.7.3 Electronic records will be backed up on a regular basis, according to 90A0127- Electronic Records Back-up and Archival. Back-ups will be stored in a safe location, preferably off-site. Proprietary ZOLL
ZOLL Number: 90E0004 Page 12 of 15 5.7.4 Quality Records are available for review and duplication by ZOLL employees. 5.7.5 Outside auditors (e.g., employees of the Food and Drug Administration) may also receive copies of these documents, provided they are NOT marked CONFIDENTIAL. All requests should be processed through the Quality Assurance department and a complete record maintained of all duplication. 5.8 Record Location: 5.8.1 All Quality Records are typically maintained by the group responsible for the development of that record. Refer to the Quality Record Matrix (Appendix A) for the specific location of each record. 5.9 Length of Storage: 5.9.1 Quality Records shall be maintained for a minimum of 12 years from the date of record creation, with the exception of employee training records, which shall be maintained for 12 years from the date of termination of employment. Proprietary ZOLL
ZOLL Number: 90E0004 Page 13 of 15 Appendix A Quality Records Matrix This matrix is the key to identifying and locating Quality Records. It includes the Quality Record name, a description of the record, the method of indexing, file location, responsible group, minimum length of storage and the document s disposition upon expiration. Quality Record Description Method of index File location / responsibility Minimum length of storage Disposition Management Review Record Corporate Quality Council meeting minutes. Date QA Quality System Record Index of procedures required by 21 CFR 820, but not product specific. order Corrective Action Requests Records of all internal corrective action requests. order Supplier Corrective Action Requests Records of all external corrective action requests. order Supplier Quality & Inspection and Nonconformance Reports File of all inspection and nonconforming material reports. order Dock to Stock List List of parts qualifying for the Dock to Stock Program. Date Audit Reports Records of internal and audits. order Supplier Evaluations Records of external supplier audits and evaluations order Supplier Quality & Design Review Records Records and minutes of all design reviews. order Design History Files Compilation of records which describes the design history of a finished device. Index Proprietary ZOLL
ZOLL Number: 90E0004 Page 14 of 15 Quality Record Description Method of index File location / responsibility Minimum length of storage Disposition Device Master Record Compilation of records containing the procedures and specifications for a finished device. Index Mfg Eng & Technical File Compilation of product information required by the Medical Device Directive 93/42/EEC. Technical File Category Device History Record Compilation of records containing the production and service history of a finished device. Top level: Serial or lot # Lower level: order of Work Order Purchase Orders Copies of all purchase orders. Alphabetical by Vendor Name Procurement & Equip. Maintenance Records of all equipment maintenance. Equipment ID and in the equipment database Mfg Eng & Calibration Records Records of all equipment calibrations Equipment manufacturer, ID, and Calibration database Mfg Eng & Material Review Board Records Copies of all records of Material Review Board decisions. Order Approved Suppliers List List of all suppliers currently approved for use. Database / ERP System Procurement Employee Training Records General Employee and Job Specific Training Records. Alphabetical by employee name. ZOLL on-line training platform or designated functional trainers. 12 years from date of termination of employment Destroy Proprietary ZOLL
ZOLL Number: 90E0004 Page 15 of 15 Quality Record Description Method of index File location / responsibility Minimum length of storage Disposition Complaint Report Forms Records of all product complaints received from the field. Order* RA & Adverse Event Reports Records that are associated with an adverse event that occurred in the field. Order Grouped by Year *Complaint Report Forms associated with Adverse Events will be filed with the Adverse Events RA & System Problem Reports Records of all discrepancies detected primarily during design verification & validation. Order Change Orders Records of all changes made to approved documentation Order. Medical Device Tracking Missing Data Log Log listing the aware date of the missing data, the date(s) of the missing data, the description of the missing data, and the reason the data is missing and why data could not be collected. Order Proprietary ZOLL