Urs Preparation

JETT

URS PREPARATION PROCESS

Page 1 of 7 Doc ID: 371760693.doc March 27, 2002

URS PREPARATION PROCESS

JOINT EQUIPMENT TRANSITION TEAM

URS PREPARATION PROCESS

JETT

Page 2 of 7 Doc ID: 371760693.doc March 27, 2002

REVISION HISTORY Rev.

Date

Approval

A

28/3/2002

Revision Summary

Draft Version

JOINT EQUIPMENT TRANSITION TEAM

JETT

URS PREPARATION PROCESS

Page 3 of 7 Doc ID: 371760693.doc March 27, 2002

Table of Contents 1.0

PURPOSE.........................................................................................................................4

2.0

PROCESS........................................................................................................................4

3.0

Typical Interview Questionnaire Topics...........................................................................6

JOINT EQUIPMENT TRANSITION TEAM

JETT

URS PREPARATION PROCESS

Page 4 of 7 Doc ID: 371760693.doc March 27, 2002

1.0 PURPOSE This document is intended for organizations evolved in the preparation of a User Requirements Specification (URS) document for automated manufacturing or process equipment. It presents the JETT Consortium recommended process for gathering, defining and documenting the users requirements. Additional guidance may be found in ISPE’s GAMP Guide for Validation of Automated System, GAMP4, Dec. 2001.

2.0 PROCESS 2.1

Identify Roles

As a first step, it is important to identify an individual who represents the end-users of a desired manufacturing or process equipment solution. The role of this individual will be to act as a primary contact and project coordinator for the organization involved in the URS preparation. The same individual will help in the identification of resources and groups that will participate to the interview process and will facilitate the scheduling of those interviews. It is also the role of the Project Coordinator to clearly identify who will be the reviewers and the approvers of the formal URS document. The roles and responsibilities of these individuals involved in the preparation of the URS should be clearly stated in the URS document. 2.2

Define the Scope

It is imperative that the scope to be covered by the URS be clearly defined and agreed upon. Boundaries and exclusions in the functionality, data, interface and environment sections must be clearly identified and documented in the URS document. In order to properly define the scope, the author(s) of the URS will refer to documents such as a project proposal, a formal problem statement, a value proposition, conceptual design documents and other sources whenever applicable, and will also discuss with the project coordinator or the targeted system owner(s). A schematic representation of the desired solution should be considered for inclusion in the URS for sake of clarity. 2.3

Identify participants to the Interview Process and Schedule Interviews

In order for the URS to properly describe the users requirements, it is important that a number of resources and potential users be interviewed. The interviews will help define the expected functionality, the environment, the operational constraints, company policies and applicable regulations.

JOINT EQUIPMENT TRANSITION TEAM

JETT

URS PREPARATION PROCESS

Page 5 of 7 Doc ID: 371760693.doc March 27, 2002

It is important to interview individuals that cover a broad range of functions, not limited to immediate potential users. Individuals involved in Operations, Information Technology (IT), Engineering, Management, Quality Assurance and Maintenance should be included in the interview process. The project coordinator shall facilitate and possibly make all arrangements for scheduling all interviews and work sessions required for gathering the information. 2.4

Prepare Interview Questionnaires

In order for the interviews to be efficient and complete, questionnaires shall be prepared. The questionnaires shall include questions related to all major sections of the URS, as defined in the document BLANK URS TEMPLATE_RevA8.doc or other agreed upon template. Questionnaires shall also be adapted depending on the function performed by the individuals participating in the interview process. Typical topics are provided in Section 3 of this document as a starting base for building a questionnaire. The project coordinator may consider sending the Interview Questionnaire as part of the interview schedule confirmation to allow individuals to better prepare and possibly gather documents that could be used as references. The interview process could also take the form of brainstorming work sessions. In such case, a document including the meeting agenda and background information shall be prepared and sent to participants to lead the discussions in an organized manner. 2.5

Conduct Interviews and Work Sessions

When many individuals representing the same function are to be interviewed, for example, operators and supervisors of the same operations department, it is recommended that these individuals be interviewed as a group to favor synergy. Questionnaires must be used for all interviews and notes must be taken during the work sessions to ensure that the discussions are well documented. Minutes of meeting presenting a summary of the requirements expressed during the interview should be submitted to all interviewed participants to ensure there is no false interpretation on the needs and requirements. Additional questions may be presented to the participants at that point to complement or confirm gathered information. 2.6

Analyze Data and Prepare Draft Version of the URS Document

Once all interviews are completed, or as a continuous development effort during the interview process, the URS document shall be prepared using the BLANK URS TEMPLATE_RevA8.doc document template and other agreed upon template. No sections / sub-sections shall be deleted and all shall be filled. In the case where no requirement applies to a particular section or sub-section, the description shall specify "Not applicable". At this point, it is required to clearly and precisely describe what the users want the manufacturing or process equipment to do, and distinguish between essential

JOINT EQUIPMENT TRANSITION TEAM

JETT

URS PREPARATION PROCESS

Page 6 of 7 Doc ID: 371760693.doc March 27, 2002

requirements and merely desirable features. There should be no ambiguity in the expectations of the users. Additional guidance may be found in Appendix D1 of ISPE’s GAMP Guide for Validation of Automated System, GAMP4, Dec. 2001. 2.7

Submit Draft Version for Review

The draft version of the URS document shall be sent for review to the agreed upon list of reviewers based on the organization document management policy. A reasonable period of time shall be allowed to all reviewers to complete the review process and submit changes or comments. Required changes or comments shall be submitted in writing or formally documented by the author(s) in the case where the changes/comments are expressed verbally. Additional meetings may be required to discuss proposed changes or comments. 2.8

Submit Formal Version for Approval

At the end of the draft version review period, author(s) shall incorporate agreed upon changes and comments and submit the formal version of the URS in printed form to all URS approvers. It shall be noted that the URS will be subject to reviews throughout the manufacturing or process equipment life cycle and shall therefore be subject to change control. All formal copies of the URS document with approvers' signature shall be retained. Additional Good Documentation Practice are presented in ISPE’s GAMP Guide for Validation of Automated System, GAMP4, Dec. 2001.

3.0 TYPICAL INTERVIEW QUESTIONNAIRE TOPICS The following topics shall be considered when preparing an interview questionnaire: 3.1      

Management Topics Identification of organization’s goals and objectives Expected benefits Budget and resources Time, security, procedural and maintenance constraints Existing infrastructure, policies and practices Contract and Services agreement

3.2 

Operations Topics Intended equipment usage (range of products, production rates, availability, etc.)

JOINT EQUIPMENT TRANSITION TEAM

JETT           3.3           

URS PREPARATION PROCESS

Page 7 of 7 Doc ID: 371760693.doc March 27, 2002

Environmental constraints (physical location, room classification, vibration, temperature, altitude, cleaning, etc.) Profile of users (functions, skills, experience, language, training, etc.) Modes of operation Desired functionalities Security and safety Reliability and redundancy constraints Scalability Automated system and database technologies Preferred equipment and components manufacturers Existing engineering documentation standards or conventions. Equipment Topics Production and quality performance Components assembly and construction Operators and external systems interface (hardware and software platforms, network protocols to be supported, etc.) Utilities (control air, process water, electricity, etc.) Equipment configuration and setup Development, testing and maintenance tools Alarms, events, messages and reports Training, maintenance and qualification documentation Data recording, time stamping, handling, access and storage System backup and restore Remote access and administration

JOINT EQUIPMENT TRANSITION TEAM