Feasibility Study Linda Doll

Health First Pharmaceutical Company

Health First Manufacturing Division

Feasibility Study

DR & CM Consulting International

Linda Doll Principal Consultant

Document History

o Document Location / Revision History/ Approvals /Distribution

The original copy of this document will be kept in the office of the

Quality Manager of Health First Manufacturing Division, in their facility in Sydney,

Australia. Approved copies will be sent to the Project Board, all stakeholders, and

corporate headquarters in Kent, Ohio, USA. A copy will also be posted to the company

intranet.

Glossary

o CGMP/Code of Good Manufacturing Practice

o DCS/Document Control System

o HFMD/ Health First Manufacturing Division, Sydney, Australia.

o HFPC/Health First Pharmaceutical Company.

o IDCM/ Integrative Document and Content Management.

o ISO/International Organization for Standardization

Executive Summary

o Project Initiation

The Project Board approved the Project Initiation Document for the implementation of a

Initiation Document for the implementation of a solution to effectively manage HFMD

quality documents. Subsequently, the Project Board approved the engagement of DR &

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CM Consulting International to conduct a feasibility study as part of the preliminary

investigation of requirements.

o Problem or Opportunity Definition Summary

The Quality Manager has raised concerns about the current practices and systems in

regards to the management of quality documents. Specifically, he has found obsolete

documents in use. The current state of practices/systems was such that the HFMD is at

risk of losing its ISO quality accreditation with potentially significant results for the

company’s operation. In order to avert the company failing a quality audit, and therefore

losing the International Standards Organization (ISO) accreditation, the Quality Manager

and headquarters in Kent, Ohio arranged for a Project Initiation Document, to more

thoroughly assess the situation. Sufficient grounds were discovered to justify the

commissioning of a feasibility study, to also be conducted by DR & CM Consulting

International.

o Target Environment Summary

The scope of the project had identified the manufacturing facility located in Sydney,

Australia as the target environment for the feasibility study, with headquarters involved

in an ancillary role.

o Options Analysis Summary

Options to address the shortcomings of the current quality document management

procedures and systems range from do nothing to the implementation of an IDCM system

with Intranet.

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Option Key Advantages Key Disadvantages

1. Do nothing Least project cost Problem not resolved

2. Business

workflow

amelioration

Moderate cost

Modest Improvements

Will help,

but not address

underlying problem

3. CDM

management

system

Will address

quality document issues

Will not be workable

with the other divisions

of HFPC

4. ICDM system

with Intranet

capabilities

Will address quality document issues

May be scaled to work with all divisions of HFPC

Most expensive option,

and most difficult

and involved transition

o Preferred Option

The preferred option is a combination of options 2 and 4; workflow and paperwork will

be streamlined, and an IDCM system integrated with the company Intranet, will be

utilized to track, maintain and keep current all quality documentation in regards to the

manufacturing division of Health First.

o Way Forward

The next project will be a user requirements specification, to be conducted by DR & CM

Consulting International. Stakeholders representing HFMD’s quality management

system will be interviewed in focus groups or one/one in order to ascertain requirements

for the system. This information will be vital to the identification of the best IDCM

system to fit the requirements of HFMD.

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Introduction

o Purpose

The purpose of the feasibility study is to clarify/confirm the issues with managing quality

documents within HFMD and to determine preferred business/technology solution

options to provide an effective system for managing quality documents.

o Background

HFMD, a part of Health First Pharmaceutical Company, is located in Sydney, Australia.

The division is the major manufacturing facility for HFPC. For further information

concerning the initial perception of the problem, and the instigation of the response to the

problem, we refer you to the Project Initiation Document, also by DR & CM International

Consulting, and the Initial Terms of Requirement. Copies can be obtained by contacting

the Project Owner, the Quality Manager of HFMD; a copy is also to be found on the

company intranet.

o Project Definition

The aim of the project is to find a solution to the issues raised with respect to managing

quality documents and thereby maintaining HFMD’s accreditation rating with ISO.

o References

Coleman, Linda. Project Initiation Document. Version 1.0, May 5, 2008.

Health First Manufacturing Division. Terms of Requirement. Version 1.0, January 7,

2008.

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o Acknowledgements

The DR & CM Consulting International wishes to acknowledge the

cooperation of the stakeholders of HFMD; their honesty and whole-hearted

involvement have made these recommendations more accurate and

responsive.

Problem Definition

o Business environment

HFPC enjoys prominence as a world leader as a supplier of quality

pharmaceuticals. The record growth, coupled with expansion into

previously untapped markets, have combined to put strain on procedures and

systems, once deemed adequate, that are perceived as no longer efficiently

supporting business objectives, operations and processes.

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o User environment

User Type User Roles # of Users

Contributor/Creator Quality Manager

Documentation Officer

1

1

Collaborator

(Review and approval on

documents)

Business

Department

Managers

3

Consumers

(primarily search,

retrieval, view, printing)

Work center users 79

The manufacturing division of Health First enjoys a relatively modern

facility located just outside of Sydney, Australia. The work force is

relatively homogenous, composed mainly of Australian nationals. Their

education level is having some college, from a high of doctorate holders that

compose and check the formulations, to less successful academic careers for

janitorial and support staff. HFMD also has a relatively low turnover rate.

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o Document environment

The following types of documents are used in the quality process:

Document Types Prefix Retention (Years)

Quality System/Manual QM 10

System Management Procedures SMP 10

Standard Operating Procedures SOP 10

Operating Instructions OI 10

Test Methods 10

Raw Materials

Finished Products

Analytical Methods

Microbiological Methods

RMQS

PQS

AM

MM

Position Descriptions PD 1

Forms FOR 1

Registers, Logs, Lists REG 1

Drawing Office & Technical Library 10

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o Technical environment

The procedures and systems in place to track and maintain the paperwork necessary to

comply with ISO 9001 guidelines are for the most part not automated. Numerous manual

steps have added to insufficiencies that have become apparent over time.

o Benefits of current environment

The benefits of the current environment are:

The procedures are known.

The initial outlay for the mostly manual system was relatively cheap, and worked

well enough for HFMD to obtain it current level of success and security.

The metadata in the Document Control System has been well managed and

describes key properties of the quality management documents.

The quality documents are identified in the file system by a metadata tht will

support the import of these documents into the IDCM system.

o Limitations of current environment

The limitations of the current environment are:

It is only a matter of time before the system fails; at that time HFMD will fail a

quality audit, and lose it ISO accreditation. This will have immediate financial

repercussions, as well as constituting a blow to HFPC’s prestige. The loss of

good will on the part of the public may well be a blow that HFPC would not be

able to recover from.

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The Document Control System, which contains the metadata HFMD quality

documents, is a proprietary system which does not support strategic IT objectives

for inter-operability between business systems.

The current document paradigm does not support strategic direction for business

and technical interfaces to improve overall processes within the company.

o Summary

The benefits of not changing the system, or of doing nothing and waiting for

circumstances to dictate themselves, are too costly to consider. The possible benefits of

finding and implementing a system would result in insuring ISO accreditation, plus the

cost savings resulting from improved efficiencies would render action at this time an

advantage.

Factors Influencing Future Directions

Strategic

o Enterprise mission and objectives

The enterprise mission is to maintain market share and expand into more lucrative fields.

The company’s adherence to regulatory and quality management system standards is a

vital key to supporting the overall mission. Thus, the objective of finding a solution to

the management of quality documents, and the assurance of ISO accreditation is vital to

the furtherance of the long term strategy of the division and of the overall corporate

strategy as well.

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o Strategic business planning imperatives

The problems with quality document management are seen as an imperative issue to

resolve; it is a weakness that threatens the viability of the corporation both in the short

run, and over the long term. Future planning and growth are seen as at risk due to these

unresolved issues.

o Legislative and regulatory requirements

Whatever solution is considered, it must comply with both ISO standards and the CGMP

in addition to all other applicable U.S. Australian and international regulations.

o Long-term budget strategy

The cost of finding and implementing a solution has been weighed against the potential

costs associated with the loss of accreditation and potential legal liability The potential

cost of a solution is seen as something that could be spread over operating costs of the

next few years, offset by savings accrued through improved efficiencies.

Tactical

o Tactical business planning imperatives

The approved solution must be cost effective, timely and maintainable by current staff.

The solution and it eventual implementation, must not result in any cessation or

slowdown in production.

o Management reporting requirements

The new system will produce management reports on the timeliness of review and

approval of new or amended quality documents. The system will produce exception

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reports where tasks for quality document review and approval are not processed within

three days.

o Information system interfaces

The proposed system will not be required to interface with the computer aided drawing

(CAD) program used by Engineering, as this has been deemed beyond the scope of this

project. For further information, please refer to the Project Initiation Document, listed

under References.

Operational

o Accessibility and usability requirements

The proposed solution must be easily accessible and useable by the stakeholders and

management alike.

o Operational reporting requirements

Management has expressed a desire for a solution that would consolidate reporting

functions, making the necessity of coordinating multiple reports that are not designed to

meld together a thing of the past.

o Migration requirements

The proposed solution will include data migration from the existing Document Control

System and from the network file system to the new IDCM system as a requirement.

Target Environment

o Outline target environment description

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The proposed solution will:

Enable employees to access documentation concerning formulation of

products in a timely manner, with the assurance that the formulation that they

are accessing is the correct and most current formulation.

The capture level requirement is to enable creators of new and amended

quality documents to capture documents into the system in a simple manner.

The registration of metadata for new documents shall be simplified using

innovative categorization methods.

The review and approval of new and amended documents will be automated

to facilitate the timely authorization of documents.

o Gap analysis

The gaps are seen as:

The current quality document procedures and systems involve much manual

handling, compounded with the inability to keep current with changes, and the

resulting problems with unauthorized duplication and obsolete documentation

occurring and persisting.

The Document Control System and the documents in the file shared are not

interfaced. This means that metadata needs to be updated in a separate system

(i.e., DCS) each time a document is created or updated. With the IDCM

system in place, the metadata and document objects will be integrated.

Users currently have to search the DCS for metadata that describes the

document, and then go navigating to a file system to locate the document. In

the new IDCM solution, a metadata search should return a list of documents

that are relevant and allow the user to access them directly.

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Solution Option Analysis

Option 1: Do nothing

o Operational feasibility

It is always possible to do nothing; the problems associated with the current ineffective

and insufficient procedures and systems will not go away, and will only worsen with

time. The advantages include no change in operations which would avoid disruptions.

o Technical feasibility

It is also technically feasible to do nothing, but it will do nothing to solve the

shortcomings of the current quality document procedures and systems. Loss of ISO

accreditation is almost certain to follow.

The DCS is a proprietary system which will need to be decommissioned in the short to

medium term to support IT inter-operability strategies. If the decommission of the DCS

is not included in this project, then a separate project would be required to address this

issue in the short to medium term.

The advantage of this option is that DCS contains the metadata that enables search on

quality documents. The file systems used to support quality documents are stable and

integrated with backup/ recovery processes.

o Economic feasibility

The do nothing option had the benefit that there is no requirement to provide a budget

and resources for a project to implement a new solution.

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Option 2: Business Solution

The Business Solution option is to implement revised policies and procedures for

managing quality documents, and to improve controls on monitoring of processes and

management. This solution embraces a review of current methods of disseminating documents

to work centers with the view to improving processes.


A pure business solution is operationally feasible and would be the simplest solution,

beyond the do nothing option. It will not answer to all the current problems, and will

probably be insufficient to address future concerns.


The technical feasibility is the same as the previous option; please refer to technical

feasibility under the do nothing option.


A business solution is economically feasible, representing a partial solution for a modest

amount of money.

Option 3: IDCM solution

An Integrated Document and Content Management system would consist of a

systematic integrative approach to implementation and management of Document Management

System, Content Management System and Record Management System, and how these systems

are associated with workflow.

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An IDCM system will implement effective management controls over quality documents,

support process improvement for review and approval of processes and provide the

foundation for presenting the right information to users in the work center. This is

achieved by eliminating hardcopy records at the work centers and publishing the current

versions of digital documents to the work center.

During the package selection process, the candidate systems will be assessed to

determine their flexibility, scalability and extensibility for wider deployment within the

organization.


An IDCM system is technically feasible, and would solve the current quality document

control issues, which would count as an advantage.

These systems exhibit the functionality required to capture and manage quality

documents, support required metadata, and deliver automated review and approval

processes. They also feature integrated web publishing to enable controlled copies of the

quality documents to be published to work centers.


While not as economically attractive as the previous two solutions, we feel the cost of the

system balanced against the costs of doing nothing make this an attractive solution.

A disadvantage would be that there is significant volatility in the IDCM software with

rapidly emerging and competitive technologies, and considerable technology

convergence and mergers/acquisition activities. This risk will need to be assessed and

mitigated (wherever possible) during the package selection process.

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Option 4: IDCM with Intranet solution

This solution would feature:

A document management system to implement controls over new and

amended quality documents.

Integrated workflow to support the review and approval of new and

amended quality documents.

Integrated web publishing tools to manage the publication of PDF

renditions of controlled documents to Intranet.

Intranet integration such that allow work center to search and retrieve

quality documents in the IDCM system.


An IDCM system with intranet combination is operationally feasible, especially

considering that the company already has an established intranet. It would simplify

operations and position the company for future expansion.


Advantages:

Document management system that integrates with HFMD networks and

operating environment.

Integrated workflow that is compatible with a document system.

Integration with Intranet to support IS strategy to use Intranet as interface to

business systems and information.

Decommission of proprietary Document Control System.16

Disadvantages

There is a risk that the technology may be superseded in the short to medium

term. Document management and integrated workflow systems are evolving

technology convergence; vendor mergers/acquisitions and trend towards

commoditization of document technologies.


Advantages

This is the most expensive and technologically involved system, and as such

does not have much in the way of economic advantages.

Disadvantages

With the possibility of technological convergence, the higher costs of this

system might not prove to be money well spent.

Preferred Options: Options 2 and 4

o Justification

The efficiencies that could be garnered by implementing and improved business solution,

coupled with the speed and improved security of an IDCM system with intranet, offers

the best combination of amendment of the current insufficient system, coupled with the

ability to grow with the company, and to keep pace with future demands.17

o Recommendation

We recommend an overhaul of the paperwork involved in the manufacturing process,

from initial formulation to final shipment of product, coupled with the purchase,

installation and integration of an IDCM system with intranet capabilities. We believe

that this will resolve current issues with quality document processes and systems, and

will also result in a system that will be able to keep pace with the increased demands that

the projected growth of the company would entail.

Impact Statement

o Impact on business

Impact to work center productivity during planning and implementation of

new solution.

Impact on culture due to changeover from hardcopy document review and

approval and access to automated review and approval and digital access to

controlled documents.

These impacts will be mitigated by a Change Management Strategy that is

designed to minimize the risk to work center productivity and support

changeover to working in a digital environment.

o Impact on other projects

As this project is seen to be vital to the continued success and future growth of the

company, it is being given precedence over any and all other projects.

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o Legislative/policy issues to be resolved

There are no legislative issues to be dealt with at this time. Policy issues that may come

up concerning headquarters in Kent, Ohio will be the responsibility of the Project Owner.

This project is being considered a pilot for potential application corporation wide; its

success and its being brought in on time and within budget is a worthwhile goal, and will

be guarded as such.

o Technology issues to be resolved

The candidate solution will be assessed in terms of its capability to be

flexible, scalable and extensible for wider deployment.

The candidate system will also be assessed for its’ ability to migrate data from

the existing DCS.

The proposed solution should be easily maintained by IS.

The proposed solution should be Dublin Core compatible.

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Summary and Conclusion

o Feasibility study outcomes

The Project Owner and Project Board should meet and consider the recommendations of

the feasibility study. The Program Manager and staff will make themselves available to

explain any portion of the feasibility study and to answer any questions.

o Way Forward statement

The Project Owner and the Project Board having met, and having considered the options

and settled on one, will communicate that decision to the Project Manager and staff. The

Project Manager and staff will then begin preparations for the next step in the process, the

formulation of the User Requirements Specification.

o Conclusion

The feasibility study has examined business and technology solution options for an

effective solution for managing HFMD’s quality documents. Four solution options were

considered and it is recommended that the Project Board approve a combination of

options 2 and 4, which is the preferred option based on the Feasibility Study Report.

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Documents

Feasibility Study Linda Doll