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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
Title Prepared by
Standard Operating Procedure on Manual, Policy and SOP writing Dr Nabeel Al Nahass, HOD, GMCH
Ver. 1.0
Approval Matrix Activity Reviewed by Print Name and Title Dr. Manvir Singh Med Director, GMCH Dr Prashanth Hegde COMS Mr Akbar Moideen Director, GMCH Mr. Thumbay Moideen, Founder President and Chairman Signature Date
Reviewed by Reviewed by
Approved by
Yearly (or new) management review and approval: Signature acknowledges SOP version remains in effect with no revisions. Print Name Signature Date
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 1 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
Table of Contents 1 2 3 4 5 6 7 8 9 10 Introduction.................................................................................. 3 Purpose ....................................................................................... 3 Scope .......................................... Error! Bookmark not defined. Abbreviations & Definitions.......................................................... 3 Responsibilities ........................................................................... 4 Procedure .................................................................................... 4 References .................................................................................. 8 Enclosures .................................................................................. 8 Validity Statement ...8 Change log. 12
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 2 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
INTRODUCTION: To maintain adequate oral health, a regular dental check up and professional cleaning of oral cavity is required.
PURPOSE: The objective of scaling and polishing is to remove or eliminate the etiologic agents like dental plaque, its products and calculus thus helping to establish a disease free oral cavity.
SCOPE 3.1 This document provides guidance for indication, procedure protocol. 3.2 Applicable to Gulf Medical University and its associated institutions.
4. ABBREVIATIONS & DEFINITIONS 4.1 GMU: Gulf Medical University 4.2 QA: Quality Assurance 4.3 Standard Operating Procedure (SOP): Detailed formatted,
authenticated and controlled document containing instructions to achieve uniformity of performance for a specific function or procedure. 4.4 Approved date: Date on which the document is approved. 4.5 Effective date: Date from which the SOP comes into force for implementation, which is usually 30 days after the approval of the document unless stated otherwise. 4.6 Revision Summary: A brief write up mentioning the reason for review of the current version and the changes thereof.
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 3 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
5. RESPONSIBILITIES 5.1 Primary Responsibility: It is the responsibility of the concerned operating clinicians and dental hygienist in the Dental Department to read and implement this SOP. 5.2 Secondary Responsibility: It is the responsibility of the designated Quality Assurance personnel to verify the compliance to the
Manual/SOP and submit a periodic report to the management. It is the responsibility of the management to ensure the compliance to the SOP implemented.
PROCEDURE
6.1 Indication of procedure: Scaling & polishing may be carried out on all patients where other dental procedures may be undertaken. Specific indications are: I. II. Cases of gingivitis, periodontitis. Post treatment maintenance phase.
6.2 Procedural protocol: I. II. III. IV. Warmly greet and seat the patient in the chair. Confirm patient identity by name and hospital ID number. A well informed consent is obtained from him. Confirm patient health status (h/o communicable diseases) by reviewing patients chart. V. VI. Patient protective attire is taken care off. Pre-procedural mouth rinse for 1 min is advised.
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 4 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
VII. VIII.
Patient education and motivation is done using disclosing solution. A sterilized ultrasonic scaler is used to clean the teeth in a quadrant or sextant wise order.
IX.
A high vacuum suction is used to clear out the water pooling in the mouth of the patient.
X.
After the scaling is completed, based on the soft tissue and dental conditions polishing is done using a polishing paste, polishing cup or brush and low speed micromotor hand piece.
XI. XII.
The patient is safely dismissed from the chair. Following the completion of the procedure, the patient is given a post operative instruction sheet.
XIII.
Patient is explained about the appropriate brushing techniques, interdental cleansing aids and chemical measures of plaque control.
XIV.
Follow up appointment is scheduled with the patient and its importance is well explained to him.
XV.
Patient records-In detail charting of the procedure is done in the patient record file.
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 5 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
7.1 When to review a Manual or an SOP? The SOP should be reviewed if all or any of the following conditions arise: Detection of a deficiency in the existing Manual/SOP, which requires correction. In case of additions due to new requirements. Procedure or Technique undergoes modification. Equipment or a part thereof is modified or upgraded. At the direction of the HOD. On the direction of the Quality Assurance auditor. On expiry of the validity of the Manual or SOP.
7.2 Who can review a Manual or an SOP? Individuals knowledgeable of the activity and the organizations internal structure are eligible to review the Manual/SOP. A team approach is recommended in review of the Manual or SOP. At least one person from the concerned department and one from QA should review the Manual/SOP. 7.3 How to review and withdraw previous version of a Manual or an SOP? Review should be initiated periodically on a yearly basis. Review or withdrawal can be done after identification of a deficiency in the SOP. This should be documented as per the SOP deviation form. A written consent should be obtained from the HOD and QA for this purpose. Whenever a new version is to be issued, QA should ensure the recall of all the copies of the SOP in the workplace. Destroy all old copies. The Master copy in QA should be sent for archival and the new version to be filed in its place with a subsequent master list update.
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 6 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
No two different versions and copies of the same SOP should be present at any given place.
6.4
How to destroy a Manual or an SOP? It is discouraged to have printed copies of SOPs. Destroy all these
copies in a shredder or by burning. 7.5 Confidentiality: The onus of assessing the confidentiality of all the SOPs lies with the respective HOD of the department and QA. They should ensure that proprietary information in an SOP should not be copied, electronically stored or transmitted in any form or whatsoever either in full or a part thereof. 7.6 Dos and Donts with a Manual or a SOP: Do not mutilate, fold or spoil the Manual/SOP. In case of such incidents, bring it to the notice of the HOD or QA. Do not keep the Manual/SOP with personal belongings such as books, in bags, pockets, etc Replace the Manual/SOP back carefully after reading in its original place. Avoid reading the Manual/SOPs on workbenches to prevent its soiling and contamination. Do not write or underline or highlight any part or line of a Manual/SOP. Do not handle the Manual/SOP with working gloves on. Start the work only after reading the Manual/SOP. Do not perform the work and read the Manual/SOP at the same time. If multiple steps
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 7 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
are involved, read the Manual/SOP in parts followed by completion of the work in parts. Do not handle the Manual/SOP near a water or fire source.
Title
Clinical Periodontology Carranza Xth edtn Rationale of mechanical plaque control. Westfelt E. J Clin Periodontol.1996 Mar;23(3 Pt 2):263-7.
9 ENCLOSURES
9.1 9.2
Appendix I: Manual/SOP proposal form Appendix II: Identification of deficiency and amending an Manual/SOP
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 8 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
Reason for requirement of a new Manual/SOP 1. New process 2. Change in the regulatory requirements 3. Inclusion of new methods 4. Procurement of new equipment 5. Any other, please specify Proposal Submitted to QA by
Yes/No
Acceptance communicated on
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 9 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
(Signature
(Return this form to QA along with the master copy of the Manual/SOP)
Serial No. GMCH/Gen SOP/01/F2 Manual/SOP Number: Manual/SOP title: Version No.:
(Enclose annexure, if necessary) Proposed amendment to overcome the above deficiency or the problem
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
(Signature
Yes/No
If yes, acceptance communicated to Name: Mode of communication: Acceptance communicated on Signature and date of HOD (To initiate Manual/SOP review) Review responsibility delegated to Responsibility accepted by (Name) with date) (Return this form to QA along with the master copy of the revised Manual or SOP and Filled Form) (Signature
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 11 of 12
Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 01 Jan 2013
Change Log Ed. Effective date Reason for revision/ Changes Revised with/ without changes Date / Sign.
Signature and date of HOD (To initiate Manual/SOP review) Review responsibility delegated to Responsibility accepted by (Name) date) (Signature with
(Return this form to QA along with the master copy of the revised Manual or SOP and Filled Form)
This Document is confidential and proprietary to Gulf Medical College and Hospital SOP ID: GMCH/QA/1 SOP version # 1.0 CONFIDENTIAL: Authorized for internal use only. Page 12 of 12