dr.anil k.dhiman-health

Quality Management Systems : 

Dr.Anil K.Dhiman 1 Quality Management Systems An Introduction

Objectives : 

Dr.Anil K.Dhiman 2 Objectives Understand the requirements &Directives. Appreciate the benefits that a Quality Management System brings to an Health Facility. Be able to initiate the process toward being accredited/ designated, authorised or licensed.

Key Steps in the Process : 

Dr.Anil K.Dhiman 3 Key Steps in the Process Select the required Quality Management System. Using the selected standard, define the requirements across the different areas. Train all staff in the specific requirements and auditing techniques. Establish a multifunctional team. Carry out internal audits across the different areas to identify the gaps (if any). Draw up action plans to plug the gaps.

Quality Management System - Definition : 

Dr.Anil K.Dhiman 4 Quality Management System - Definition The Quality Management System is defined as the organisation structure, responsibilities, activities, resources and events that together provide organised processes and techniques of implementation to ensure the capability of the organisation to meet quality requirements.

Benefits of Accreditation/ Authorisation : 

Dr.Anil K.Dhiman 5 Benefits of Accreditation/ Authorisation It provides assurance to the service users that their requirements will be met. It allows management to communicate organisational quality objectives in an efficient manner. A Quality Management System involving all staff ensures an integrated approach and promotes quality awareness and teamwork. It brings a culture of step wise continuous improvement to an organisation.

Benefits of Accreditation/ Authorisation Cont’d : 

Dr.Anil K.Dhiman 6 Benefits of Accreditation/ Authorisation Cont’d It allows the organisation to benchmark itself against similar organisations. Accreditation provides evidence to external parties that the organisation has reached the standard required to carry out prescribed functions.

Process Approach : 

Dr.Anil K.Dhiman 7 Process Approach International standards promote the adoption of a process approach when developing a Quality Management System. For an organisation to function effectively, it has to identify and manage numerous linked activities. These activities can be considered processes. The output from one process directly forms the input to the next.

Quality Management System : 

Dr.Anil K.Dhiman 8 Quality Management System General Requirements The organisation shall:- Identify the processes needed for the Quality Management System. Determine the sequence and interaction of these processes. Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.

Quality Management System Cont’d : 

Dr.Anil K.Dhiman 9 Quality Management System Cont’d General Requirements The Health Facility shall:- Ensure the availability of resources and information necessary to support the operation and monitoring of these processes. Monitor, measure and analyse these processes. Implement actions necessary to achieve planned results and continual improvement of these processes.

Management Requirements : 

Dr.Anil K.Dhiman 10 Management Requirements

Management Requirements cont’d : 

Dr.Anil K.Dhiman 11 Management Requirements cont’d

Organisation and Management Requirements : 

Dr.Anil K.Dhiman 12 Organisation and Management Requirements The organisation shall be legally identifiable. The organization must have a Quality Management System which meets all requirements of the directives & innovations. The services, including interpretation and advisory services, must meet patient needs and requirements of clinical personnel.

Organisation and Management Requirements Cont’d : 

Dr.Anil K.Dhiman 13 Organisation and Management Requirements Cont’d Entrust to a responsible person & Establish a quality organization. Appoint a Quality Manager. Provide adequate resources (personnel, equipment and facilities). Conduct regular Quality Management System management reviews. Prepare organisational charts.

Quality Management System : 

Dr.Anil K.Dhiman 14 Quality Management System Quality Policy Quality Manual Training Establish Quality Objectives

Document Control : 

Dr.Anil K.Dhiman 15 Document Control Describe the Document Control system. Documents must be reviewed and authorised. SOP for retention and storage of records. SOP for control of archive documentation. Amending documents. Audit quality documents annually. Master list of documents and retention times.

Document Control cont’d : 

Dr.Anil K.Dhiman 16 Document Control cont’d For critical activity, materials, equipment and personnel must be identified. Access to data must be restricted.

Personnel : 

Dr.Anil K.Dhiman 17 Personnel Job Descriptions Personnel Policies Induction Training Professional Qualifications Competency Testing Responsibilities Clearly Defined Training/ Re-Training Informed of Ethical Issues

Resolution of Complaints : 

Dr.Anil K.Dhiman 18 Resolution of Complaints There must be documented procedures for handling complaints. Records of complaints, their investigation and corrective action taken by the organisation must be maintained. Staff should be aware of such activities.

Identification and Control of Non Conformities : 

Dr.Anil K.Dhiman 19 Identification and Control of Non Conformities There must be a documented procedure describing the actions taken when non conformities are detected. These procedures must include a definition of what constitutes a non conformity, what actions are taken and who is responsible for this, what is done to prevent reoccurrence.

Identification and Control of Non Conformities Cont’d : 

Dr.Anil K.Dhiman 20 Identification and Control of Non Conformities Cont’d Each non conformance must be documented and these records must be reviewed at regular intervals by Hospital Management.

Corrective and Preventative Action : 

Dr.Anil K.Dhiman 21 Corrective and Preventative Action Internal and external data is reviewed to identify problems and appropriate corrective and preventative actions (user satisfaction and complaints, internal system and process audits, external QA data, quality improvements…) Procedures for corrective and preventative actions must include an investigation to determine root causes.

Corrective and Preventative Action Cont’d : 

Dr.Anil K.Dhiman 22 Corrective and Preventative Action Cont’d Effectiveness of corrective and preventative actions must be monitored and evaluated at management review.

Continuous Improvement : 

Dr.Anil K.Dhiman 23 Continuous Improvement Action plans for improvement shall be developed, documented and implemented as appropriate. Prepare training plan. Management shall monitor effectiveness of the improvement action plan at management review. Results of the improvement programme must be communicated to all staff.

Internal Audits : 

Dr.Anil K.Dhiman 24 Internal Audits Documented internal audit programme. Prepare annual internal audit programme. This programme must evaluate both the Quality Management System and every process in the loop. Review audits.

Management Review : 

Dr.Anil K.Dhiman 25 Management Review Goals and objectives versus progress Close out of complains and non conformances Monthly quality meetings Quality monitors External audits Third party assessments Feedback from clinicians/ patients

Facilities/ Premises : 

Dr.Anil K.Dhiman 26 Facilities/ Premises Suitable design and workflow Critical parameters controlled and monitored Storage conditions defined Specified air quality- validated Written gowning instructions Segregate storage – in quarantine/ released/ rejected Security/ restricted access Cleaning/BMW Management

Equipment : 

Dr.Anil K.Dhiman 27 Equipment Equipment must be shown to be capable of achieving the performance required (qualification). The equipment must have documented calibration and preventative maintenance programmes. Each piece of equipment must be uniquely identified.

Equipment Cont’d : 

Dr.Anil K.Dhiman 28 Equipment Cont’d There should be procedures for operation and cleaning. Specification of reagents and materials must meet directives on invitro diagnostics and medical devices.

Important : 

Dr.Anil K.Dhiman 29 Important Identify Requirements and Fix Goals Identify the responsible Team for Identified Goal Understand what is the present way of working (Process) and how it works What have we already (Resources) Identify gaps (Ways and Means) Curative Actions

Important-Cont. : 

Important-Cont. Feed-back & Monitoring Non-conformities & ATR Further Monitoring and plugging of gap Preventive Measures Continue interaction/Trainning & monitoring Evaluate & ACHIEVE the Goal Fix the BETTER Goal and Go for it Dr.Anil K.Dhiman 30