Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

Title Prepared by

Standard Operating Procedure on dental procedures

Dr. Nabeel Al Nahass and dental team. Approval Matrix

01 Dec 2012

Activity

Reviewed by

Print Name and Title Mr.Mohammed Irshad Farouk Quality Assurance Officer Dr.Manvir Singh Med Director, GMCH Dr Prashanth Hegde COMS Mr Akbar Moideen Director, GMCH

Signature

Date

Reviewed by Reviewed by Approved by

Three yearly or new management review and approval: Signature acknowledges SOP version remains in effect with no revisions. Print Name Signature Date

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

DISTRIBUTED PAPER COPIES TO: Nil

ISSUED BY QA GMCH

USE IN CONJUNCTION WITH SOP(S)

All Policies, Manuals and SOPs will refer to this SOP

WORKING AREA(S) RELEVANT TO SOP

All departments of GMCH&RC

REVISION HISTORY Previous SOP Number 46xxx.GL.Ver 1.0 Revision summary

Multiple changes in document following observations forwarded after review by JCI

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

Table of Contents 1 2 3 4 5 6 7 8 9 Introduction .................................. Error! Bookmark not defined. Purpose........................................ Error! Bookmark not defined. Scope ........................................... Error! Bookmark not defined. Abbreviations & Definitions ......................................................... 5 Responsibilities ........................................................................... 6 Procedure ................................................................................... 6 References................................................................................ 12 Enclosures ............................................................................... 12 Validity Statement 12

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

OCCLUSAL SPLINTS

1. INTRODUCTION Occlusal splints are removable dental appliances carefully molded to fit the upper or lower arches of teeth They are used to protect tooth and restoration surfaces, manage mandibular (jaw) dysfunction TMD, and stabilize the jaw joints during occlusion or create space prior to restoration procedures.

2. PURPOSE: A mouthguard is most often used to prevent injury in contact sports, as a treatment for bruxism or TMD or as part of certain dental procedures, such as tooth bleaching. Depending on application, it may also be called a mouth protector, mouth piece, gumshield, gumguard nightguard, occlusal splint, bite splint, or bite plane.

3. SCOPE This SOP defines the mechanisms for developing, maintenance and implementation of Policies, Manuals and Procedures.
1.1

This SOP also describes how Policies, Manuals and Procedures that originated outside the organization will be controlled, and implemented This SOP describes policies for storage and retention of written in use policies, obsolete retired policies, and procedures for ensuring that they will not be mistakenly used or implemented.

1.2

1.3

This SOP also outlines how all Policies, Manuals and Procedures in circulation will be identified and tracked, and implemented.

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

1.4

This document provides guidance for preparation, drafting, format, style, language, review, release, distribution and withdrawal of Policies, Manuals & Procedures.

1.5

This SOP is applicable to Gulf Medical College Hospitals associated institutions.

and its

2 ABBREVIATIONS & DEFINITIONS

2.1 2.2 2.3 2.4

GMCH: Gulf Medical College Hospital QA: Quality Assurance Approved date: Date on which the document is approved. 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

2.5

Revision Summary: A brief write up mentioning the reason for review of the current version and the changes thereof.

2.6

Policy: A principle or rule to guide decisions and active rational outcomes.

2.7

Manual: A technical document intended to assist staff using a system or equipment e.g., IT Manual & ECG instrument manual

2.8 2.9

Procedure: is a document written to support a policy. SOP: Standard Operating Procedure (SOP): Detailed formatted, authenticated and controlled document containing instructions to achieve uniformity of performance for a specific function or procedure. Standard operating procedures are detailed written instructions to

achieve uniformity on a certain function. E.g. Testing for Blood Glucose using the Olympus AU640.

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

3 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.
3.1

Responsibility of Approval of policies, manuals and SOPs: It is the responsibility of the Management to approve appropriate and relevant Policies. Manuals and SOPs will be approved by the technical heads after consultative review with all relevant

stakeholders. 4 PROCEDURE 6.1 Indication of procedure: I. II. III. IV. V. VI. Dental trauma Oral medicine Bruxism Teeth bleaching Orthodontics TMD disorder

6.2 Procedural protocol: I. Professionally and warmly greet and seat the patient in the chair.

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

II. III. IV. V. VI.

Confirm patient identity by name and hospital id number. A well informed consent is obtained from him. Confirm patient health status by reviewing patients chart. A protective eye wear and dental bib are placed on him. Make an impression in either alginate or rubber base material, disinfect and send away to the lab for fabrication of night guard/splint of acrylic or thermo plasticized sheet).

VII. VIII. IX.

Try on the patient, clear any excessive Correct High spots in occlusion, A finished denture is rechecked for all parameters and then delivered to the patient.

X.

Follow up appointment is scheduled with the patient and its importance is well explained to him.

XI.

In detail charting of the procedure is done in the patient record file.

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

4.3

Procedure for review and approval of all Policies, Manuals and Procedures by an authorized person before issue When to review a Manual or a SOP? The SOP should be reviewed if all or any of the following conditions arise: o Detection of a deficiency in the existing Manual/SOP, which requires correction o In case of additions due to new requirements o Procedure or Technique undergoes modification. o Equipment or a part thereof is modified or upgraded o At the direction of the HOD o On the direction of the Quality Assurance auditor o On expiry of the validity of the Manual or SOP

Who can review a Manual or a 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.

When to review a Policy. A policy may be reviewed periodically (3 years) or as required by the management. Policies support the course of GMCH and changes in policy should be infrequent.

Who can approve a Policy, Manual or SOP

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SOP ID: GMCH/QA/1 SOP version # 2.0

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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

Policies are approved by the head of the institution. Manuals & SOPs can be approved by the technical head of the function using the SOP.

Frequency of review and continued approval of policies and procedures Policies, Manuals and SOPs are to be reviewed routinely every 3 years. Rreview 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.

Version control Only current, relevant versions of policies and procedures should be available wherever they are used Electronic Copies: All SOPs should be preserved in a Document Management System (DMS) with version control and electronic retention. All electronic documents should have a watermark Confiden tial Document not valid if printed.

Paper Copies: When it is not possible to have an electronic document management system paper copies can be maintained. Whenever a new version is to be issued, QA should ensure the recall of all the copies of the SOP in the workplace. One copy is to be archived and destroy all old copies. The Master copy in QA should be sent for archival for a period of 15 years and the new version to be filed in its place with a subsequent

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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

master list update. No two different versions and copies of the same SOP should be present at any given place.

Identification of changes in policies and procedures All changes in SOP should be appended in brief on the table on page no 2 of the SOP.

A process for managing policies and procedures that originated outside the organization Policies external to the organisation if required to be internalised have to be examined for suitability. They have then to be internalised. In case of manuals & SOPs originating outside the organisation (e.g kit literature) the same will be utilised against the previous version/document in use and examined for changes. A date of receipt, date of starting use and date of last use are recorded on the document. Once the SOP/kit use is completed, the same will be archived. All used SOPs will be archived electronically for a period of 15 years.

How to destroy a Manual or a SOP? It is discouraged to have printed copies of SOPs. Paper copies destroyed in a shredder or by burning. Identification and tracking of all policies and procedures in circulation 1. All paper copies of SOPs issued will be issued by the QA and the distribution of numbered controlled copies will be noted. Once the SOP is retired the same will be withdrawn. are

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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

2. Electronic copies will be tracked and stored in a version controlled manner in a document management system.

Confidentiality: The onus of ensuring the confidentiality of all the SOPs lies with the respective HOD of the department and QA. They should ensure that proprietary information in a SOP should not be copied, electronically stored or transmitted in any form or whatsoever either in full or a part thereof.

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 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.

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Site: GMCH Ajman Date of issue: 10 Jan 2013

Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

7. REFERENCES 7.1 McCracken's Removable Partial Prosthodontics 7.2 Removable Partial Dentures: A Clinician's Guide. John D. Jones, Lily T. Garcia 8 ENCLOSURES o Appendix I: Manual/SOP proposal form o Appendix II: Identification of deficiency and amending a Manual/SOP

9. VALIDITY STATEMENT This SOP is valid till 12 of Jan 2016 15 days.

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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

Policy/ Manual/ SOP Proposal Form (APPENDIX-I). Serial No. GMCH/Gen SOP/01/F1 Proposed title of the Manual/SOP Reason for requirement of a new (Pen down the serial number, in case of Manual/SOP S.No.1,2,3,4) 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 (Name) (Signature) Proposal Submitted on (Date) Is the proposal accepted by QA? If No, specify the reason Yes/No

If yes, acceptance communicated to Acceptance communicated on Signature and date of Approver Preparation responsibility delegated to Responsibility accepted by

Name: Mode of communication:

(Name) (Signature with date) (Return this form to QA along with the master copy of the Policy/ Manual/ SOP)
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Title: SOP on Manual, Policy and SOP writing Date of effectiveness: 30 Jan 2013

Form for Amendment of a Deficiency / Problem Identified in a Policy/ Manual/SOP (APPENDIX-II) Serial No. GMCH/Gen SOP/01/F2 Manual/SOP Number: Manual/SOP title: Version No.:

Description of a deficiency or the problem identified in the Manual/SOP: (Enclose annexure, if necessary) Proposed amendment to overcome the above deficiency or the problem

The deficiency is identified by (Name) with date) Signature with date Yes/No (Signature

Authentication of HOD Is the proposal accepted by QA? If No, specify the reason If yes, acceptance communicated to Acceptance communicated on Signature and date of HOD (To initiate Manual/SOP review) Review responsibility delegated to Responsibility accepted by

Name: Mode of communication:

(Name) (Signature with date) (Return this form to QA along with the master copy of the revised Policy, Manual or SOP and Filled Form)

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