BME 174 QP1. Quality System Procedure PDF

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Summary

Mandatory group assignment...

Description

SOP # A-174-10.1 Revision No. 1 Supersedes A-100

Page 1 of 7 Effective Date: 02/09/18

Assigning, Collaborating, Researching, Writing, Editing, Reviewing and Approving Homework Assignments [Group No. 10] AUTHORS:

________________________________________________ Trevor Cabreros

____________ Date

________________________________________________ Netnapit Saengpitayathon

____________ Date

_________________________________________________ Lucero Sandoval

____________ Date

_________________________________________________ Maria Tam Tran

___________ Date

__________________________________________________ Nam Tran

___________ Date

_________________________________________________ Cassandra Villicana

___________ Date

APPROVED:

__________________________

______________________________

Cassandra Villicana (Manager)

Maria Tam Tran (Quality Assurance Manager)

Reviewed Initial

NS

TT

NT

CV

TC

LS

Date

2/9/18

2/9/18

2/9/18

2/9/18

2/9/18

2/9/18

TABLE OF CONTENTS

SOP # A-174-10.1 Revision No. 1 Supersedes A-100

SECTION

Page 2 of 7 Effective Date: 02/09/18

SECTION TITLE

PAGE

A.

PURPOSE

3

B.

APPLICABILITY

3

C.

SUMMARY OF METHOD

3

D.

DEFINITIONS

3

E.

RESPONSIBILITIES

4

F.

PROCEDURE

5

G.

RECORD MANAGEMENT

6

Access and Location of Work-in-Progress and Finished Projects

6

Assignment Retention

6

H.

QUALITY ASSURANCE & QUALITY CONTROL

7

I.

REFERENCES

7

A. PURPOSE This document serves as an Standard Operating Procedure (SOP) for researching, developing, assigning, writing, reviewing, editing and submitting assignments. It highlights the importance of team responsibilities and contains guidelines to help the team delegate

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tasks and priorities. The team will refer to this document as the semester progresses. B. APPLICABILITY This SOP is specified for use in our BME 174: Biomedical Regulatory Requirements class and should be accessed and referenced when assignments are assigned to Group 10. The document is set to identify tasks and roles for the group of six members.

C. SUMMARY OF METHODS The group will meet after the assigned date of assignments to verbally discuss and form agreements on project topics and deadlines. Verbal agreements will be written as an email, which will contain the synopsis with important ideas highlighted and be sent out to all group members. Individual work will then be done in reference to the email and SOP. Two days before the submission deadline, an agreed upon Google Hangout time will take place to proofread assignment. Once final revisions are made, a notification will be made to Maria (Tam) and the assignment will be submitted.

D. DEFINITION SOP: Standard Operating Procedure - A standard operating procedure is a written document or procedure that describe the methods to be follow and/or practice in order to achieve the desired outcomes [1]. SIPOC Diagram - A SIPOC diagram is a chart for Suppliers, Inputs, Process, Outputs, Customers. It is a tool which can be used to identify all relevant elements of a process [2]. Supplier - A supplier is a person or a party which provide something that needed such as goods or services. Input - An input refers to what is taken into a process or a system. Process - A process is a series of steps taken to achieve a particular goal. Output - A product refers what is produced by the process. Customer

SOP # A-174-10.1 Revision No. 1 Supersedes A-100

-

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A customer is a person or a party which receive a product or service from businesses or other party.

E. RESPONSIBILITIES a. Author: An author is responsible for writing an assignment. b. Team Member: A team member is responsible for doing his or her assigned part of the assignment by the deadline. The team member is also responsible for discussed or reported problems regarding the assignment to other team members and/or to the project manager. c. Project Manager: A project manager is responsible for overseeing the different aspects of a project or an assignment [3]. In addition, the project manager will create a timeline for each assignment based on the deadline. With everyone’s consents, the project manager will divide and assign part(s) of the assignment to each team member. Moreover, the project manager will check on each team member periodically, to assure that the team member is on the right track. d. Quality Assurance Manager: A quality assurance manager is responsible for setting a quality standard for each assignment and ensure that a finished assignment meet the standard. In addition, the quality assurance manager will work with each team members to monitor the assignment against agreed targets [4].If the quality of any team member individual work does not meet the standard; the manager will either talk to that team member directly or talk to the project manager. e. Reviewer: A reviewer is responsible for read and review sections or the whole assignment when it completed. f. Researcher: A researcher is responsible for gathering necessary information for an assignment. When required, multiple team members can research different topics from the assignments. Once sufficient information is collected, the researcher is responsible for study the information and share it with the team. Team member

Responsibility

Trevor Cabreros

Author, Researcher, Reviewer

Netnapit Saengpitayathon

Author, Researcher, Reviewer

Lucero Sandoval

Author, Researcher, Reviewer

SOP # A-174-10.1 Revision No. 1 Supersedes A-100

Page 5 of 7 Effective Date: 02/09/18

Maria Tam Tran

Author, Quality Assurance Manager

Nam Tam

Author, Researcher, Reviewer

Cassandra Villicana

Author, Project Manager

F. PROCEDURE Once assignment has been announced by the Professor Coronado, then it is the responsibility of all group members to read the directions in respect to the assignment. Afterwards, to fully comprehend what is being asked of the group, there will be a dedicated time to discuss the requirements amongst the group. For further understanding, the team manager, Cassandra, will take any concerns about the assignment and contact the professor directly for clarification. Moreover, team manager will communicate that information to the group members. Then Maria will, start a google document, shared with everyone in the group, and all group members will contribute there work. Trevor will take on the responsibility of delegating and facilitating the group tasks. Netnapit, will be taking into account the group notes and agreements throughout the process. Afterwards, through the means of research, Nam Tran will investigate that the information used by the group is correct. Then, Lucero will be modifying the assignment, if needed, and verifying that the requirements are met. Lastly, Maria will proofread the overall assignment and submit on the Canvas website. Once a Canvas Submission Notification has been sent, then the Group 10 will have completed their task.

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G. RECORDS MANAGEMENT I.

ACCESS AND LOCATION OF WORK-IN-PROGRESS AND FINISHED PROJECTS One member will be delegated the task of creating a Google Drive folder designated to store work-in-progress and finished assignments along with relevant documents for the assignments for class. Each assignment will be labeled with assignment date and assignment name. Team members will have access to the folder through sharing Google emails, which will also be accessible on their Google Drive. II.

ASSIGNMENT RETENTION Finished assignments will be kept in a Google Drive folder designated for class, which will be accessible to all team members. Team members will gain access to the folder through sharing Google emails, and non-team members will not have access to the folder. H. QUALITY CONTROL AND ASSURANCE Team members will review the assignment at the end of each step in the process described in the SIPOC diagram. After the professor has assigned homework/assignment

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on Canvas, team members will work together to identify the goal of the assignment during the meeting. Then, a follow-up message or an email will be sent to each team member to confirm the individual’s role in the assignment. When each member has completed his or her parts on Google docs, the reviewers will review the document and provide feedback. The feedback also will be used during the revision phase. The revision phase will repeat when necessary. Once the assignment is complete or nearly complete, the scope of the assignment will undergo analysis by the quality assurance manager. The assignment will be turned in on Canvas once the quality assurance manager and the project manager has approved the final draft.

I. REFERENCE SECTION [1] Good one to know! (n.d.). Retrieved February 09, 2018, from http://www.businessdictionary.com/definition/standard-operating-procedure-SOP.html [2] SIPOC Diagram. (n.d.). Retrieved February 09, 2018, from https://www.isixsigma.com/tools-templates/sipoc-copis/sipoc-diagram/ [3] Project Manager Job Description - How to Become a Project Manager | Snagajob,. (n.d.). Retrieved February 08, 2018, from https://www.snagajob.com/jobdescriptions/project-manager/ [4] Quality assurance manager: job description. (2017, March 09). Retrieved February 08, 2018, from https://targetjobs.co.uk/careers-advice/job-descriptions/278249-qualityassurance-manager-job-description...