open source qms development strategy (copyright-patented)

--MASTER THESIS--

QMS Development based on DIN EN ISO 13485

standard inside XWIKI software platform and

accounting for the feasibility of this development

method

Dec 5th 2012, Hochschule Anhalt & Martin Luther Universität

JUNAED SHAFI

AHAMED

MBE 2010

1• Plan

2• Develop

3• Implement

4• Maintain

AGENDA

Introduction

Objectives

The model company and study entities

XWIKI basics and features for QMS

QMS development approach

Results

Summary and Conclusion

Scope for further studies

References

2


INTRODUCTION

Why do companies need a QMS?

Customer satisfaction [1] Achieve organizational objectives [1]

Need for new QMS implementation methods [2].

Growth of open source WIKI systems for enterprise

management [3] [4].

Challenge from Acuros Gmbh to develop QMS using XWIKI 3.4

system.3


• Introduction

• Objectives

• The model company and study

entities

• XWIKI basics and features

• QMS development approach

4

CHALLENGE ACCOMPLISHED


• Introduction

• Objectives


entities



5

PROPOSED RESEARCH APPROACH


Following orchestral QMS development approach

Describing and understanding the organization of medical technology company

2

1

Declaring XWIKI based QMS concepts applicable for the company

3

Proving the feasibility of XWIKI based QMS by accounting for the capability of this system to handle customer complaints 4

• Introduction

• Objectives


entities



Experience gained from working with Acuros GmbH was used to develop a

research outline for XWIKI based QMS development.

OBJECTIVES

Capability of XWIKI 3.4 to comply with QMS requirements of

DIN EN ISO 13485 standard.

How to use XWIKI 3.4 to develop QMS and discuss a step

wise development protocol.

To validate the feasibility of XWIKI based QMS for an

imagined medical company with 100 employees.

6


• Introduction

• Objectives


entities



7

Organizational chart of the hundred employee medical device company.

THE MODEL COMPANY CHART

CEO

Quality Manager

Medical device safety

officer

Project Cathete

r

R&D

Administrative Assistant

Project Aspirator

Project Manage

r

Design Developmen

t

Services

Project Manage

r

Design Developmen

t

Services

Basic Development

Business Development

Manager

Computer

systems

Software experts

IT Manage

r

Purchase Manager & Accountant

Industry Production & Logistics Manager

Production

Logistics

Mechanical

Storage

Transport

Outsourced Processes

Internal Processe

s

Electronics

Sterilization

Packaging & Labeling


• Introduction

• Objectives


entities



8

Already possess a certified QMS using paper based method and decided to transfer QMS into real-time management using XWIKI 3.4.

DESCRIPTION OF ORGANIZATION

Devices sold by the company include

Diagnostic Cardio Vascular Catheters (Class III device). Aspirator vacuum pumps (Class I device).

State of the art device design, manufacturing and storage facilities

Biological, chemical and mechanical labs Equipped with good IT infrastructure and service computers installed with

XWIKI 3.4.

Sterilization process is outsourced.


• Introduction

• Objectives


entities



IMPORTANT ENTITIES IN THIS STUDY

9

MDD 93/42/EEC

EN ISO 13485:2010-01 standard

QMS

XWIKI 3.4

WIKI

5 Entities around

which this study

revolves

Establishes the essential

requirements and harmonized standards

applicable for medical technology

companies operating in the

European Economic Area (EEA) [5].

Harmonized standard that can

facilitate the compliance with

the MDD 93/42/EEC requirements for

establishing a QMS [6].

A set of coordinated activities,

procedures or instructions to

direct and control an organization in

order to continually improve the

effectiveness and efficiency of its

performance [7].

Special website with a built in

software that can be accessed by users using any web browser to add, edit and

delete the information saved in its file system or

database [2].

An enterprise WIKI sold by XWIKI SAS, which is

integrated with open source functionality

features that are powered by a WIKI software based on JAVA scripts [8].


• Introduction

• Objectives


entities



TYPES AND ROLES OF XWIKI USERS

XWIKI Administrator(s)- Responsible for management of XWIKI.

• Assign access rights to every other WIKI user.

• Create spaces – Departments of a company, Projects, Quality,

Archive etc.

• Create pages / documents and also exercise special rights.

Author – creates documents / pages.

Modifier(s) – edits information inside documents / pages.

Approver – validates the information inside pages / documents.

Readers – use the document for work purpose.

10


• Introduction

• Objectives


entities



11

Internet Intranet / LAN

https://(company name).net:8483

http://(server name)7:9880

Login to the XWIKI system User name Password

XWIKI 3.4 START UP


• Introduction

• Objectives


entities



12

Activity Stream Document control, Communication

FEATURES OF XWIKI FOR QMS

History Record control – Preservation, Protection, Legibility, Identification and Retrieval

File Attachment Record control

Import Record control


• Introduction

• Objectives


entities



Create a new page / document and give suitable name.

13

Two document editing modes What you see is what you get (WYSIWYG) Source Editor (Java scripting)

Velocity & Groovy scripts

DOCUMENTATION IN XWIKI 3.4


• Introduction

• Objectives


entities



14

QMS DEVELOPMENT APPROACH


Create all the necessary spaces inside XWIKI system

Organize a Quality Committee

2

1

Select an appropriate QMS documentation pyramid pattern

3

Planning the management of documents and records inside corresponding spaces

4

Provision of access rights for employees involved in QMS development5

Proposed stepwise strategic procedure for QMS development.

• Introduction

• Objectives


entities



15

QMS DEVELOPMENT STAGES


Organize a Quality Committee

Chief Executive Officer (CEO) Management representative (Quality Manager) Medical Devices Safety Officer Managers from all departments and documentation experts /

specialists

Create all the necessary spaces inside XWIKI system- Document & Record allocation

XWIKI Administrator must create nine spaces. Assign responsibility of each space to its concerned personnel.

Records

Records

Records

Records

Records

Records

Records

Records

Records

Documents

Documents

• Introduction

• Objectives


entities



Select an appropriate QMS documentation pyramid pattern

16



Self standing document providing framework for QMS of the

company [9].

Can be referenced inside the QMS Manual or described in detail

inside operational procedures [9].

Standard operational procedures (SOP), Standard Forms (SF) –

Templates, Checklists, Charts etc [9].

• Introduction

• Objectives


entities



Provision of access rights for employees involved in QMS development

17



Provide user with: - • XWIKI login name• Login password• Access to XWIKI

user manual page

• Access to SANDBOX space and test pages

Personnel responsible for the task: XWIKI Admin

1

Trained to use

XWIKI?

Use training

evaluation checklist.

Provide XWIKI training:

Use XWIKI training template

Personnel responsible for the task: IT manager

2

NO

Trained successfu

l?

Use training

evaluation checklist.

• Change administrator given password

• Complete profile information (add picture, personal information and email address)

Personnel responsible for the task: New User

3

YES

YES

Not considere

d

NO

• Allow viewing rights to QUALITY MANAGEMENT space, QUALITY MANAGEMENT MANUAL space and the associated department space.

Personnel responsible for the task: XWIKI Admin

4 Procedure for selecting QMS documentation

members

• Introduction

• Objectives


entities



Provision of access rights for employees involved in QMS development

18



QMS page creator – Documentation and compliance specialist

QMS page modifier(s) – Concerned departmental manager / space owner

QMS page approver – Quality Manager

Why access rights provision??

To view and access spaces

To view the pages inside the authorized spaces

To edit the pages which are authorized to view

Name of the User

Designation XWIKI login name

Trained for using XWIKI

(Yes) / (No)

Names of spaces

authorized to view

Names of pages viewed inside

authorized spaces

Names of pages with

editing rights

Name 1CEO

(XWIKI

Admin)Yes

All (Restrictions apply)

All (Restrictions

apply)

All (Restriction

s apply)

name 1 Yes

• QMS• QMM

Name 2 IT Manager name 2Yes

• QMS• QMM

Name 3 Project Manager (Catheter)

name 3 Yes

• QMS• QMM• Project

Catheter

• Introduction

• Objectives


entities



19



All applicable Standard Operational Procedure (SOP) (except – sterilization procedure)

from section 4 to section 8 of the EN ISO 13485:2010-01 standard.

The SOP draft pages / documents are reviewed for effectiveness

against [10]: -

Functionality

Human interfaces

Resources utilized

Consistence with quality policies

Potential to address quality objectives

Interfaces with the organization’s customers and suppliers QMS manual documentation – Quality policies, Quality Objectives and

provide framework.

• Introduction

• Objectives


entities



After QMS is documented into XWIKI, schedule training session.

20

RESULT


Benefits over previous method can be proven by studying the

management of customer complaints inside XWIKI 3.4.

Different real life situations for addressing customer complaints: -

1) Arrival as email or fax message.

2) Documented by a company representative or affiliate using

customer complaint template.

3) Telephonic conversation with the customer.

4) Customer using complaint template.

21

RESULT – SOP & SF FOR COMPLAINT HANDLING


Medium of complaint arrival

As email / fax messages Documented by a representative

from the company using complaint tempate

Telephonic conversation Customer using the complaint

template

Incoming cusomter complaints

• All complaints documented into template• Telephonic complaints recordedResponsible person: - Administrative assistant

• Assign compliant number and forward to concerned department manager

Responsible person: - Administrative assistant

• Assign task to employee• Use CAPA (SOP 8-5-2)Responsible person: -Department manager

Collect additional

information

Is complai

nt legitima

te?

• Report to manager with proper and valid reason of analysis

Responsible person: -Inverstigating personnelYE

S

• Confirm complaint with administrative assistant

Responsible person: -Departmental manager

Provide replaceme

nt?

YES

NO

• Inform and send replacement to cusotmer

Responsible person: - Administratiive Assistant

• Inform customer and issue credit voucher

Responsible person: - Administratiive Assistant

• Report to manager with proper and valid reason of analysis

Responsible person: -Inverstigating personnel

NO

• Verification of reasons stated in template

Responsible person: - Department Manager

NOReasons valid?

• Inform administrative assistant with valid reasons

Responsible person: -Department Manager

YES

Store all records in QUALITY CONTROL space

Responsible person: - Medical device safety officer

Customer complaint template (SF 8-5-1-3-a)

SOP 8-5-1-3

22

RESULT


Device batch page inside Quality Control space before complaint arrives.

Pages stored inside Project Aspirator space

Pages stored inside Manufacturing & Logistics space

23

RESULT


1) When complaint arrives as email / fax – information transferred to SF 8-5-1-3-a.

24

RESULT


Proposed action for customer complaint handling in case 1 –

Device batch page after complaint was registered

Record of addressed complaint (SF 8-5-1-3-a)

Original data from the Customer

25

RESULT


2) When complaint is documented and forwarded by an Representative / Affiliate – information transferred to SF 8-5-1-3-a at the customer site.

26

RESULT


Record of addressed complaint (SF 8-5-1-3-a)

Proposed action for customer complaint handling in case 2 –

Device batch page after complaint was registered

27

RESULT


Proposed action for complaint handling in case 3 (telephonic conversation) –

Device batch page after complaint was registered.

28


The proposed methods for handling customer complaints tentatively prove

the feasibility of XWIKI based QMS development.

XWIKI features promote potential to favour QMS maintenance – many

options for record and document management.

Secure, faster and disciplined QMS development approach that ensures

less expenditure.

Certain noticeable drawbacks from syntaxes – but no friction to QMS

development.

SUMMARY & CONCLUSION

Offers simplified management and improved responsiveness in

comparison to conventional methods.

29

SCOPE FOR FURTHER STUDIES


Can XWIKI 3.4 and its newer versions be used for other standards?

Can XWIKI support multi national organizations?

This is just the beginning. Many other open source WIKIS like TWIKI and

Foss WIKI are also available and hence they must be checked for their

potential to implement an efficient QMS.

Several other possible ways of QMS implementation using XWIKI.

Different number of spaces and pages allocation

Multi-Wiki feature favours easy coexistence with other enterprise management

software like SAP ERP, Lotus Notes etc.

30

REFERENCES


[1] – http://www.businessballs.com/dtiresources/quality_management_systems_QMS.pdf

(10.07.2012, 10:45 AM).

[2] – F. Castano, G. Mendez, J. Ayala and L. Day; http://articles.geometrica.com/64.html_

(10.05.2012, 11:00 AM)

[3] – http://bhopu.com/2008/01/using-wikis-for-collaboration-and-enhancing-organizationalknowledge/

(01.04.2012, 11:45 AM) [4] – http://www.opensource-it.com/open_source_wiki_software (01.04.2012, 12:00 PM)

[5] – http://www.opensource-it.com/open_source_wiki_software (01.04.2012, 12:00 PM)

[6] – Section 1.1 General, DIN EN ISO 13485:2010-01 Handbook, Page. 6

[7] – http://www.businessballs.com/dtiresources/quality_management_systems_QMS.pdf

(01.04.2012, 19:00 PM), logged in as: quality_management_systems_QMS.pdf

[8] – http://platform.xwiki.org/xwiki/bin/view/DevGuide/JavaScriptAPI#HXWikiJavaScriptAPI

(06.03.2012, 23:00 PM) [9] – William A. Stimson, Internal Quality Auditing: Meeting the challenge of ISO 9000:2000

(Paton press, 2001)

[10] – Section 4.2.1, ISO/TR 14969:2004(E), Page. 5

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THANK YOU

Q & A??

XWIKI 3.4 BASICS

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RDBMS

Three Tiered System Architecture and Scalability

XWIKI Data tier

Middle Tier

Business logics / Application tier

Browser

Browser

Browser

Browser

Browser

Presentation tier

Middle Tier 1

Middle Tier 2

Middle Tier 3

DesktopLaptopMobile Device

XWIKI Databas

e

Human Resources

I T

Research and Development

Manufacturing

Customer Service and Marketing

Product Management and Sourcing


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SOP FROM SECTION - 4


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