SAMPLE COMPANY Page 1 of 3 SOP # 16-1 Revision: 0 Prepared by: _ Effective Date: Approved by: _ Title: QUALITY RECORDS RETENTION AND STORAGE Policy: The company will retain quality records in an orderly fashion for time periods that comply with legal and regulatory requirements and as needed for general operation requirements. Purpose: To outline the methods for filing, retaining and purging quality records. Scope: This procedure applies to all quality records and documentation generated by the company. However, this does not necessarily cover internal or certain day to day business correspondence. Procedure: 1.0 Identification and Filing System 1.1 Quality records are identified as those documents listed in the Master Product Record index and any records pertaining to the policies, procedures and forms listed in the Quality Manual and Standard Operating Procedure Manual. 1.2 To ensure efficient access, filing centers will be established in each department. To reduce the amount of duplicate and unnecessary record retention, individual desk files should be avoided unless they are used in daily operations. All other departmental or company records should be filed in the departmental central filing areas. 1.3 The following filing guidelines should be adhered to optimize filing efficiency and records access: a. All file cabinets and files will follow recognized rules of order, such as Left to Right, Top to Bottom, Front to Back and in the case of chronological records, newest to oldest. b. File markers or label headings will always be placed at the beginning or front of a file or group of files. c. Alphabetical files should always be filed under broad topical categories. Files should never be filed under individual employee names (except personnel) to avoid confusion and refiling in the event of turnover. Files should be always filed under the "proper" or company names whenever appropriate. QUALITY RECORDS RETENTION AND STORAGE Page 2 of 3 2.0 Record Retention and Long-Term Storage 2.1 Storage of archived records will be maintained in the locked storage area of the building. Access to this area will be limited to the Quality Assurance Manager, officers of the company and the File Manager. 2.2 Non-permanent files will be stored in cardboard file boxes. Each file box will be labeled on the front with the contents, dates covered, and destruction date if applicable. Permanent records will be maintained in metal fire-resistant file cabinets. 2.3 Files should be stored only in boxes with similar items, dates and retention periods. This will allow easier access and purging of records. A general rule to keep in mind is that it is better to only half fill a file box than to file to dissimilar types of files in the same box. The file manager will be responsible for categorizing and maintaining a listing of records maintained and the location (i.e. by wall unit and shelf row number). 2.4 These holding periods will be maintained for the document listed below. Any questions regarding documents not listed should be directed to the File Manager. Document Holding Period in Years Accident Reports After Settlement 8 Calibration Records 3 Contract Review Records 6 Corrective Action Requests 3 Claim Files (Against Us) 6 Claim Files (By Us) 3 Contracts, Agreements & Leases after expiration 8 Employee Records (Terminated) 6 Engineering and Scientific Records Permanent Inspection and Testing Records 6 Insurance Claims After Settlement 10 Patents and licenses 17 Payroll Registers and Time Sheets 6 Payments and Reports to Government Agencies 6 Physical Inventory Records 6 Product Identification Records 10 Purchasing Records and Vendor Selection 6 Quality Audit Reports 3 Sales Correspondence 2 Sales Invoices and Work Orders 6 Training Records 3 QUALITY RECORDS RETENTION AND STORAGE Page 3 of 3 3.0 Record Purging 3.1 Three to six months after each year-end, the file manager will proceed with destruction of all files that have exceeded their recognized holding period. 3.2 A listing of file categories to be destroyed will be circulated to all managers thirty days prior to destruction for review and comment. The actual listing of records destroyed will be maintained permanently for future reference. 3.3 Destruction of the files will be performed by an independent, outside service for shredding and disposal. Disposal of records into the company's general trash service is not allowed.