Quality Management Systems

In Radiotherapy

Based on ISO 9001 principles

Val Antoff

Why do we need to know about Quality Management Systems (QMS)?

Accreditation against the National Safety and Quality Health Service (NSQHS) Standards will be mandatory for all hospitals and day surgeries from 1 January 2013. In WA this includes both public and private facilities.

Scope of this presentation

1. Definitions 2. Documentation requirements of QMS 3. Importance of organisation chart 4. Measuring quality 5. Making improvements 6. The documentation pyramid 7. Summary

Quality Quality Policy Process Procedure Work Instructions Quality Manual Quality Management System System Documented What to document? Control of Documents Control of Records Documentation Requirements Definitions Measurements & Improvements

Patient Satisfaction Internal Audit Monitoring Non-conformance Analysis Corrective Action Preventive Action

We are committed to Total Patient Satisfaction by providing services which meet or exceed our patients Definitions expectations. It is our policy to ensure that all patients undergoing Quality simulation have should a signed treatment consent. Quality is fitness for use, the service meet its specifications Quality Policy The quality policy is a general statement made by top management that it intends to achieve quality as a result of the company's operation. Process A series of activities, actions or functions designed to bring about a specific result. Procedure The procedure documents the step-by-step detail for the process activities and actions that must be executed in the same manner in order to always obtain the same result under the same circumstances. They typically include what, when, where, and who should do the activity identified.

Definitions
Work instruction Whilst a procedure documents the step-by-step detail for the process, a work instruction defines further details of one or several process step(s) that the business has put in place. Work instructions are for work performed in one area or function and typically tell you how to do the activity. Quality Manual The quality manual outlines the policies, procedures, work instructions and requirements of the Quality Management System and describes the interaction between the processes.

System Documented
Why do we need to document our procedures and work instructions?

Without documentation, all your tasks, functions, processes, and procedures the way that we habitually do everything are nothing more than good intentions. Processes that have not been documented are only rumours about the way we do things. If the process is not written down, how can you train others to create the same results? How do you ensure that everyone does it the same way? How do you know if that way is the best way? If it is not written down it did not happen.
Michael Gerber www.e-myth.com

What to document?
Tasks
Role
Sim RT role Warm up CT Update database Make a vac bag Capture fee codes Shut down CT

Procedure
CT Warm up CT
Database Vac bag Capture CT

Define the roles Define tasks and functions for each role Ensure that a procedure covers each task and function
Principle Say what you do and do what you say

Task and Functions of Treatment RT

Use the form below to workshop individually the tasks that each person carries out. These will make up the headings of the future content of policies & procedures that will be written in full later. It is important to drill down into the tasks so that the headings are all micro parts of a large process.
Task or Function/What is done When or how often is this function done Linac warm up Daily Check Drs notes Daily Check images Daily Check all new starts are ready Daily Treat patients Daily Authorise new files Daily Icom/iView new files Daily Load reference data new files Daily Perform imaging requirements Daily Weekly chart checks Daily Summarise finished patients Weekly Ensure all accessory equipments is Weekly safe Order new supplies Weekly Ensure linen stocked in room Weekly Perform monthly QA films Monthly Perform monthly QA MLC checks Monthly Key Area Sub element this function relates to QA QA QA QA Treatment QA QA QA QA QA QA Supplies Supplies Supplies QA QA Role responsible for this function RT RT RT RT RT RT RT RT RT RT RT RT RT RT Senior RT Senior RT

Organisation Chart
General Manager

Chief RT Senior Sim RT Senior Treatment RT

Nursing Manager Senior Planner RT

Sim RT

Treatment RT

Planner RT

Control of Documents and Records

What Documents? Meeting minutes, procedures, pathways or protocols, work instructions, forms, equipment operating instructions, regulations, local treatment programs Control of Documents

What Control? Approval, review and update, status, version, obsolete documents
How? Document Control Procedure What Records? Patient health and accounting records and others including calibration, maintenance, training, survey, audit, licensing, certifications, and other competency records.

Control of Records

What Control? Identification, storage, protection, retrieval, retention time and disposition of records How? Records Control Procedure Why? To assure legibility and accuracy of data and records, to assure that records are identifiable and retrievable

Measurements and Improvements

Patient Satisfaction Internal Audit Monitoring Analysis Thank you cards, Surveys and opinion polls chocolates, cakes etc Audit Policies and Procedures E.g. calibration, incident reporting Data

Measurements & Improvements Corrective Action

Review nonconformities Determine the causes

Implement action needed

Record the results Review effectiveness

Determine potential
Need for action Preventive Action Implementation action Record results Review effectiveness

Documentation Pyramid

What are your responsibilities in relation to the QMS?

1) 2) 3) 4) 5) Quality Policy management Processes you & your supervisor Procedure you & your supervisor Work instruction you & your supervisor Quality Manual management to ensure that there is a seamless interaction between the processes.

What is a QMS?
A quality management system (QMS) is the organisational structure, procedures, processes and resources needed to implement quality management

Summary

Accreditation will become mandatory from 1 January 2013 a QMS is a prerequisite; Unless a QMS is documented the procedures that we follow are only rumours about the way we do things; It is essential that every role has a list of tasks and functions assigned to it; The results from the analysis of the measurements and reporting data are the main indicators for quality; Improving the way we do things can be achieved only after we analyse any nonconformities and take action; It is everyones responsibility to follow an up-to-date set of procedures and work instructions and participate in the maintenance and development of the QMS;