I will upload a paper that has been written already. so please paraphrase the whole paper so that it can be different from the original. please try to come up with similar reference. also for your reference I will upload the assignment paper so that you can try to not copy and paste.
sop_lab_information_20191.docx
the_report_.docx
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EIND313 – Work Design and Analysis
Standard Operating Procedure Laboratory
DUE: 03/12/19 5:00 pm for Tuesday Labs and 03/14/19 5:00 pm for Thursday Labs
Objectives
•
To implement the strategies learned in the class and develop a standard operating procedure
for a specific task.
In-Lab Exercise
This week you will be asked to watch a video. The video shows a gowning procedure that should
be followed before entering to a clean room. After you watch the video you will be required to
develop the standard operating procedure for the gowning procedure. Your work should be done
individually. Make sure you take into consideration all the aspects mentioned in class. You can
also read the documents related to the lab exercise for your reference. Use your lab time to draft a
process chart or flow chart to be used as a reference.
Video
Your standard operating procedure will describe in detail how to do the following gowning task.
Gowning task background information
The company called SQT Medical Devices needed to update their standard operating procedure
for gowning at clean room #215 (SOP #31, Document title: Gowning procedure for clean room
#215). This procedure is used to go inside clean room #215 and to minimize the particle count at
the room. On January 15 of this year there was an audit by the Federal Drug and Food
administration (FDA). During the audit an observation was made regarding the employees
gowning procedure not being equal across employees (some employees were observed not
following the procedure) and some employees missing hair nets. After deep investigation the FDA
found out that the gowning procedure has not been updated since March 7, 2001. The last
procedure did not include the use of hair nets because the product that was manufactured in clean
room #215 was classified as Class I by the FDA and hair nets were not needed for such a low risk
product. However, back in November 10, 2017 the management of STQ medical devices added a
small manufacturing line of a sub assembly of a class III (high risk) product in clean room #215.
Even though it is only a sub assembly, because it will be part of a class III product, ALL the
employees accessing clean room #215 need to wear a hair net always, regardless if they are
working with the class I product or the class III sub assembly.
Now, assume you are the quality assurance engineer assigned to that clean room. Therefore, you
are the author of this SOP. Assume that you will be submitting your document on the lab report
deadline and the Reviewer will be the quality manager named David Rodriguez, and the approver
will be Sam Smith. Since the document needs to be reviewed and approved and you are just
submitting it you do not know the review date, the approve date and the effective date. When you
research the history of this document the only one you found was a yellowish paper copy with an
Page 1 of 3
EIND313 – Work Design and Analysis
Standard Operating Procedure Laboratory
DUE: 03/12/19 5:00 pm for Tuesday Labs and 03/14/19 5:00 pm for Thursday Labs
effective date of March 7, 2001, revision #1, document owner Mr. Gowning and it is apparently
the first document created.
Use this information to construct your SOP document. Make sure you use the template provided.
Laboratory report:
Your lab report should be a document in the form of a standard operating procedure for the
gowning task, using the template provided on D2L. You will be asked to hand in the standard
operating procedure, typed, and with all the corresponding sections. Please read the grading criteria
on table 1 for reference. Feel free to take snapshots of the video and include them in the document.
Make sure you use the SOP template provided.
In addition, include a one-page summary with all the assumptions you had to make (if any) beyond
the ones you were given to complete your SOP. The summary should be a separate document (not
part of the SOP) and can be a bulleted list of assumptions. Please include your flowchart (by hand
is ok) to your summary of assumptions.
Grading criteria:
Table 1: Grading Criteria for the Standard Operating Procedure
Item
Style
Sections
Change control
Procedure
Grading Criteria
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Total
Written in passive voice
Version number
Use of plain language
Lettering or numbering system for sections
Purpose
Scope
Definitions
Revision History
References if needed
Change control table on the first page
Table in revision history as last section of the
document
Detailed steps
Use of figures that help explain steps
Omits reasons why, just says what to do in a concise
way
Readily understandable
Neatly organized
Could someone unfamiliar with the process
complete these steps successfully?
Flowchart included
Points
Score
25
25
25
25
100
Page 2 of 3
EIND313 – Work Design and Analysis
Standard Operating Procedure Laboratory
DUE: 03/12/19 5:00 pm for Tuesday Labs and 03/14/19 5:00 pm for Thursday Labs
Page 3 of 3
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
SOP Number
1
SOP Title
A Gowning Procedure before Entering to a clean room
Approved Date
Approved By
NAME
Author
TITLE
SIGNATURE
Operator Control
Reviewer
Authoriser
Effective Date:
Page 1 of 9
DATE
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
1.
Approved Date
PURPOSE
This SOP is been developed for the purpose of describing gowning procedure before entering
to a clean room, to ensure that workers do not pollute the room. This procedure can be applied
in the whole organizations that deal with any kind of chemical aspects or any pure clean
operations. This SOP will deliver all the required steps for entering and leaving the cleaning
room with a simple language that all the worker or guests can easily understand and apply.
2.
INTRODUCTION
The SOP helps in developing a routine way of doing things with the easiest guidance to follow. It
can be a heavy indication that a firm or a company has very restricted regulations towards many
different aspects like safety. In the other hand, the SOP is also require to be applied and submitted
for every procedure in the company under the law and regulation of the United State government,
and many inspections and evaluation for the accuracy and safety of that procedures are been
inspected by the FDA. With these reasons, the SOP is a mandatory for every company to be
provided.
3.
SCOPE
These procedures will guide the people who work in the gowning field in entering and
leaving the cleaning room with the highest safety towards contamination. This procedure
can also be helpful for the training workers or the internship workers who are new to the
facility. In addition, this procedure focus on what is required to entering the cleaning
room and what is required to be done after exiting the cleaning room.
4.
SPECIFIC PROCEDURE
4.1
Procedure required to enter the cleaning room
1. Put on the hair net (Implied to all kind of hair), as shown in Figure 1
Figure 1: Put on the hair net
Page 2 of 9
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
Approved Date
2. Cover nose and mouth with face mask, as shown in Figure 2
Figure 2: Cover nose and mouth
3. Put on the hood and ensure that the hood is not inside out, as shown in Figure 3
Figure 3: Put on the hood
4. Wear the bunny suit, as shown in Figure 4
Figure 4: Wear the bunny suit
5. Wear boots to cover shoes, it should be covered tied, as shown in Figure 5
Page 3 of 9
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
Approved Date
Figure 5: wear boots
6. Wear gloves with tucking the sleeves; make it as tight as possible, as in Figure 6
Figure 6: wear gloves
7. Wear Safety Glasses, as in Figure 7
Figure 7: wear glasses
Page 4 of 9
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
Approved Date
8. Wipe down all items and tool boxes with 10% ISPROPULALEHOL (IPA), as in Figure 8
Figure 8: spry IPA
9. Check suit before entering the cleaning room, as in Figure 9
Figure 9: check suit
10. Use sticky mat to remove particles from the boots, shown in Figure 10
Figure 10: use sticky mat
Page 5 of 9
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
Approved Date
11. Use switch located on wall to active double doors, as shown in Figure 11
Figure 11: use the switch
4.2
Procedure required to be gown from the cleaning room
1. Remove boots, as in Figure 12
Figure 12: remove boots
2. Remove suit, as in Figure 13
Figure 13: remove suit
Page 6 of 9
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
3. Store suit in hanger, as in Figure 14
Figure 14: store suit
4. Store boots on cable attached in hanger, as shown in Figure 15
Figure 15 store boots
5. Remove hood, as shown in Figure 16
Figure 16: remove hood
Page 7 of 9
Approved Date
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
6. Remove face mask and hairnet, as in Figure 17
Figure 17: remove face mask and hairnet
7. Remove gloves, as in Figure 18
Figure 18: remove gloves
8. Sign-out before leaving the clean room, shown in Figure 19
Figure 19: sign-out
Page 8 of 9
Approved Date
Revision Number
Short title/ID
Modification
1
Gowning procedure
Original Version
5.
Approved Date
TABLE OF DEFINITION
Word
Definition
IPA
Is a special organic chemical of alcohol that is very
flammable with high viper pressure? Used for
cleaning and purging.
Bunny suit
Overall garment worn in the clean room, which has
an adjusted level of contaminant.
Sticky mat
Are ideal for preventing dirt and debris to enter
sensitive areas.
Gowning
Formal dress that is used for different occasions,
6.
REFRENCE
Invarma, (March 23th, 2015), YouTube. https://www.youtube.com/watch?v=Vp3_nIS1eYo.
Page 9 of 9
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