Case study and reading control form

Documentation template & evaluation instrument

Document ID : IIN311-B Effective Date: 31-AUG-2019 Rev : 3
Case: 3M healthcare Dominican Republic Page: 1 of 5

Table of Contents
1. Case / Reading title:.................................................................................................................................. 2
2. Case Study / Reading Overview............................................................................................................... 2
3. Case questions.......................................................................................................................................... 2
4. Student analysis reflection & take away.................................................................................................. 2
5. References used by the student.............................................................................................................. 2
6. Evaluation Results.................................................................................................................................... 3
7. Evaluation Rubric...................................................................................................................................... 3

IIN311-B - Case study and reading control form

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 IIN311-B Rev: 3 Case study and reading control form Page: 2 of 5

1. Case / Reading title:

Unit # and name: 1 - Introducción a la validación
Title: Case: 3M healthcare Dominican Republic
Value: 5 points
Target number of words: 250 ±50 words
Send to: cesar.tejeda@intec.edu.do

2. Case Study / Reading Overview

2.1. The company

3M Health Care Limited manufactures, procures, and markets medical, oral care, and drug delivery products.
The company develops critical and chronic care products and solutions that help prevent and treat critical and
chronic conditions across the continuum of care; infection prevention solutions to reduce the risk of exposure
to healthcare-associated infections for patients and healthcare professionals; health information systems to
help compile and use health information for better clinical and financial performance; inhalation, transdermal,
microneedle, or oral and topical drug delivery technologies for pharmaceutical and biotechnology companies;
auscultation and diagnostics solutions, including stethoscopes; a range of testing and monitoring products to
help food and beverage industries; solutions to improve clinical outcomes, enhance aesthetics, and optimize
practice efficiency; orthodontic solutions; and solutions for wound care, surgical devices, consumer health, and
microfluidics. It also offers medical grade tapes and adhesive technologies to medical device manufacturers.
The company was incorporated in 1969 and is based in Loughborough, United Kingdom with locations in the
United Kingdom and Ireland. 3M Health Care Limited operates as a subsidiary of 3M Company.

2.2. The product

Surgical tape or medical tape is a type of pressure-sensitive adhesive tape used in medicine and first aid to
hold a bandage or other dressing onto a wound. These tapes usually have a hypoallergenic adhesive which is
designed to hold firmly onto skin, dressing materials, and underlying layers of tape, but to remove easily
without damaging the skin. They allow air to reach the skin ("breathable"). Surgical tape is often white because
it contains zinc oxide, which is added to help prevent infections. Tapes made of microporous material, such as
3M Micropore, are widely used.

Figure 1 - 3M Micropore, SKU 1530-2

IIN311-B - Case study and reading control form

2.3. The context

Even though 3M Micropore sells well (approximately 60% of the sales related to surgical bands) 3M healthcare
only has one presentation available of microporous material on the USA market which is a 25mm (width) x

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 IIN311-B Rev: 3 Case study and reading control form Page: 3 of 5

5 m (long) roll with the SKU 1530-2. However, the R&D department of 3M healthcare has been working with a
new model, SKU 1535-1 which is 55% longer, 25mm (width) x 9.2 m (long) with the intention to introduce it to
the USA Market.

Figure 2 - 3M Micropore, new SKU 1535-1 (55% longer)

The new SKU will be transferred for production to the facility located in the Dominican Republic. Now, this
facility has five (5) manufacturing lines dedicated to produce the SKU 1530-2. The management has given
you full leadership of the product transfer including strategic decision.

Manufacturing processes description: A supplier delivers a big roll 25mm (width) x 100 m (long) to the
plant. Then, the roll is installed on the automatic cutting machine which unwinds the tape and re-winds smaller
rolls, cutting at the pre-set length. Operators then pack the smaller rolls on boxes manually. QC personnel
verifies randomly the overall length of the rolls.

CPP = Roll length setup on the automatic cutting machine.

CQA = Roll Length

3. Case questions
1. Scenario A: The local management decided that the new SKU will run on a dedicated line with brand new
equipment and newly hired personnel. Also, The R&D Department has completed the Design verification
of the new SKU and all specifications for production were approved.
1.1. What type of process validation would you suggest (prospective, retrospective)? Why is it
adequate?
1.2. The new machines will have a vision system that can inspect 100% of all tapes. Is process
validation needed as per FDA’s requirements (21 CFR 820.75)?

2. Scenario B: The management wants to use one of the five (5) current manufacturing lines to have backup
manufacturing capacity for the new SKU. The Operations manager says that no validation is required
because the manufacturing process for both SKUs is similar and the only difference is the length of the
tape. The length is controlled as critical process parameter of the process (CPP). In this case:
2.1. Do you think process validation is needed as per FDA’s requirements (21 CFR 820.75)?
2.2. If the current validated state demonstrated that the equipment can cut tape up to 15 meters in
a consistent and reliable way, and the new SKU only requires 9 meters. Do you think process
validation is needed as per FDA’s requirements (21 CFR 820.75)?

3. Scenario C: The management wants to retrofit all the five (5) current manufacturing lines to be able to run
this new SKU. The maintenance manager has a report indicating that the tape cutters used on the line
only require a software update to be able to cut up to 10 meters.
3.1. Do you think process validation is needed as per FDA’s requirements (21 CFR 820.70)?

IIN311-B - Case study and reading control form

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 IIN311-B Rev: 3 Case study and reading control form Page: 4 of 5

4. Student analysis reflection & take away

[Section completed by the student. Replace blue text with your answers]
Student name: Konisbell Alcántara Ureña
Group number (if applies): 1

Scenario A
Question 1.1: My suggested process validation is prospective. This is because the new SKU 1535-1 differs
in length from the SKU 1530-2. Even though the company has the needed knowledge to manufacture a
similar product, several rigorous studies must be run before it is released to the market to assure
compliance with specifications and quality attributes.
Question 1.2: According to FDA’s requirements (21 CFR 820.75), process validation is needed when the
results cannot be fully verified by subsequent inspection and test. Since the new machines will have a
vision system that can inspect 100% of all tapes, process validation is not needed.

Scenario B
Question 2.1: Process validation is needed for this specific scenario because length parameter changed,
despite the opinion of the Operations manager. Regardless of the similarity within manufacturing processes,
FDA’s requirements (21 CFR 820.75) establish that when changes or process deviations occur, the
manufacturer shall review and evaluate the process and perform revalidation where appropriate.
Question 2.2: In this case, process validation is not needed due to the validated consistency and reliability
of the equipment to cut tape within an even wider length than the required. However, safety cannot be taken
for granted because according to FDA’s requirements (21 CFR 820.75), each manufacturer shall establish
and maintain procedures for monitoring and control of process parameters for validated processes to
ensure that the specified requirements continue to be met.

Scenario C
Question 3.1: Process validation is needed in this scenario because FDA’s requirements (21 CFR 820.70)
establish that changes in specification, method, process, or procedure shall be verified or where appropriate
validated according to 820.75 (as seen in question 2.1). In addition, FDA’s requirements (21 CFR 820.70)
assure that all software changes shall be validated before approval and issuance.

5. References used by the student

In this section, the student includes external sources of information e.g. standards, regulations, upon which the
procedure/guidance is based or to other related procedures and relevant documents. APA format must be
used.

ID Title
1
2
3
(add or remove rows of the table as required)

IIN311-B - Case study and reading control form

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 IIN311-B Rev: 3 Case study and reading control form Page: 5 of 5

6. Evaluation Results
Completion Accuracy Comprehension Organization Conventions Final score
(Average)

7. Evaluation Rubric

Each case study / reading will be 5 valuated in points each. The 5-point score will be an average of the 5
different categories shown below:

Score Completion Accuracy Comprehension Organization Conventions

5 The answer is complete.
4 The answer is missing
slight details
3 The answer is missing
multiple details.
2 Content suggests lack of
preparation or
comprehension.
1 Content only marginally
related to the
question/prompt.
0 Content fails to meet the
basic requirements of
the task.
All information provided
is accurate.
All information provided
is accurate.
Most information
provided is accurate.
Some information
provided is accurate.
A small amount of the
information is accurate.
None of the information
provided is accurate.
Content demonstrates a
deep understanding of,
and engagement with,
the text(s).
Content demonstrates
understanding of, and
engagement with, the
text(s),
Content demonstrates
basic understanding of
the text(s).
Content demonstrates
less than basic
understanding of the
text(s).
Content demonstrates a
lack of understanding of
the text(s).
Content demonstrates a
complete lack of
understanding of the
text(s).
Content is well-
organized and easy to
read. Points follow a
logical progression.
Content is well-
organized and easy to
read. Points follow a
logical progression.
Content is organized and
easy to read. Points
follow a mostly logical
progression.
Content may be
unorganized and difficult
to read. Points do not
follow a solidly logical
progression.
Content is unorganized,
illogical, and difficult to
read.
Content is very poorly
organized, illogical, and
difficult to read.
No major grammatical or
spelling errors. No more
than two minor errors.
No major grammatical or
spelling errors. No more
than five minor errors.
Some major and minor
errors that don’t
necessarily impair
communication.
Major and minor errors
significantly weaken
quality of
communication, although
still comprehensible.
Communication seriously
impaired by multitude of
spelling/grammatical
errors.
Multitude of major and
minor errors make
answer
incomprehensible.

End of the document

IIN311-B - Case study and reading control form

This PPT is licensed as Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), according to creative commons. See further information regarding licensing on the following link
https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en