DOCUMENT AND RECORDS CONTROL PROCEDURE

Transcription

1 DOCUMENT AND RECORDS CONTROL PROCEDURE PROCEDURE OBJECTIVES To ensure that documents are approved for adequacy prior to use. To ensure the adequacy and appropriateness of documents are reviewed on a regularly planned basis. To ensure that changes to documents are effectively communicated to all who use them. To ensure that only the current version of any document is used. To ensure that the document used to control a process is the one specified by the QEMS. To ensure that records are consistently created to provide evidence of conformity to and enable the effective implementation of the QEMS. SCOPE All documents used to implement the QEMS are in scope. These include process descriptions, policies, procedures, forms, templates, checklists, guidance notes, job descriptions, organisational charts, documents of external origin or any other written materials used to control how work is done, who has responsibility for doing it and how data, events or opinions are recorded. RESPONSIBILITY The QEMS Manager is responsible for the communication, operation and maintenance of this procedure. All individuals who use documents are responsible for ensuring they use the current version and are responsible for raising Improvement Logs (as per the Problems, Complaints, and Improvements Procedure) if they believe there are opportunities for improvement. DEFINITIONS Documents: All forms, procedures and templates used to provide instruction and guidance including the completion of records. Document of external origin: A document used in the implementation of the QEMS where the format and content is controlled by a customer, supplier or regulatory body with whom the organisation has to exchange information. Quality/Environmental Objectives: A set of measurable objectives set by Top Management that if achieved will ensure that customer and regulatory requirements are being met and that the QEMS System is operating effectively. ASSOCIATED DOCUMENTS All associated documents referred to in this procedure are highlighted in bold and underlined. Uncontrolled when printed Page 1 of 6

2 DOCUMENT CONTROL REGISTER All documents covered by this procedure, with the exception of documents of external origin, must be loaded and stored into the Activ System. The Activ System will automatically update the: Created Date: The date the document was first made available for use. Current Version Number: The reference number used to identify the current document version to be used. Updated/Modified Date: The date the current document version was first made available for use. Templates, forms, checklists and any documents used to record data, events or opinions are stored in the relevant folder in the Templates tab. A list of all these documents, their status and control history is automatically maintained in the Templates Register. Policies, Procedures, Guidance Notes, Organisation Charts and any other written materials used to control how work is done and assigning who has responsibility for doing it but do not allow for the recording of data, events or opinions are stored in the relevant folder in the Records tab. A list of all these documents, their status and control history is automatically maintained in the Records Register. If a document has a date by which it has to be reviewed for adequacy and appropriateness then that date must be specified in the document control header in Activ. An automatic notification of the review date for each individual document will be shown in the Activ Calendar of the System Manager. CREATION OF NEW DOCUMENTS/MODIFICATION OF EXISTING DOCUMENTS New documents or modifications to existing documents may be required to enable the organisation to meet its customers requirements better, provide a new service or product, comply with new regulatory or legislative requirements, improve the efficiency and effectiveness of a process or piece of work, prevent problems/non-conformities arising, achieve its Quality/Health and Safety Objectives. The sequence of actions followed to create a new document is specified by the flow chart in Appendix A. The addition of new documents to the QHS Management System or the modification of existing documents must be communicated to all individuals who use those documents. DOCUMENT ACCESS Access to some documents may be restricted to specified individuals only. Access restrictions are established by placing documents in folders within Activ which are set to private and selecting the individuals who are allowed access to the documents within that folder. Other access restrictions can be set using the System Configuration function in Activ. Uncontrolled when printed Page 2 of 6

3 GENERAL DOCUMENT STRUCTURE With the exception of documents of external origin all documents must conform to the following structure: Title: All documents must have a title which is either positioned at the top of the document on the first page or in the document header. Footer: All non-pdf format documents must have a footer that conforms to the template in Appendix B. All pdf format documents must have a footer that conforms to the template in Appendix C. DOCUMENT REVIEW The adequacy of all documents must be reviewed at the Management Review meeting. The frequency of such reviews must be specified in the Management Monthly Meeting Agenda. Individual documents may have their own specific review schedules. These schedules must be agreed at the Management Review meeting and recorded in the document settings in Activ. DOCUMENT RETENTION Previous versions of existing documents are automatically retained in Activ. Previous versions can be used to replace existing versions provided Step 7 of this procedure is followed. Documents that are no longer required must be either deleted or moved to the Not in Use folder in Activ. All references to them in processes must be removed. These documents can be re-introduced to use provided Step 7 of this procedure is followed. COMPLETION AND MAINTENANCE OF RECORDS Records must be established wherever they are required by a process, procedure, policy or other document used to specify how work is done in the QHS Management System. Records must be legible, accurate and complete and should include any endorsement required by the correct authorised signatories. Records must be updated where information changes and the data, event descriptions or opinions are no longer deemed to be valid. Updates should be endorsed by the correct authorised signatory. STORAGE OF RECORDS Records must be stored in a secure location that is located to minimise risk of theft or damage by fire, flood or other environmental effects. Electronic records must be stored in Activ or other medium which are backed-up off site automatically. Records requiring restricted access should be stored in lockable cabinets (paper records) or in electronic folders with restricted user access (electronic records). Uncontrolled when printed Page 3 of 6

4 RETENTION OF RECORDS Records must be kept for a minimum of 5 years, with the exception of: Accounting records 7 years Employee records as per Business Link Guidance or the CIPD Guidance on Retention of Personnel and Other Related Records Archived records must be placed in a locked location and be clearly marked with the date to be retained until. DISPOSAL OF RECORDS Records must be thoroughly shredded prior to disposal or placed in the Confidential Waste bins for disposal via a recognised contractor. Uncontrolled when printed Page 4 of 6

5 New document or modification to existing document required to: Reduce the potential of a hazard to harm Improve the effectiveness of a Control Measure Provide a new service/better meet Customer requirements Comply with regulatory/legislative requirements Prevent problems or nonconformities Help achieve QSH Objectives Improvement Log raised (if appropriate) System Manager actioned to investigate Inform affected individuals of decision No Decision to amend/ create document(s)? Yes Problems, Complaints and Improvements Procedure Document(s) amended/created New document(s) added to Activ, old documents removed from all available locations Individuals who use documents notified of change Improvement Log updated & closed (if appropriate) Document change/ addition discussed at Management Review End Uncontrolled when printed Page 5 of 6

6 APPENDIX B: Footer format for non-pdf format documents: Uncontrolled when printed Date printed: <date> APPENDIX C: Footer format for pdf-format documents: Uncontrolled when printed Version number: <version number> Uncontrolled when printed Page 6 of 6