Operational Qualification document (OQ)

Documentation template & evaluation instrument

Document ID: IIN311-N Effective Date: 1-JUL-2020 Rev : 2
Page: 1 of 8

Operational Qualification (OQ)

Pre-approval document

Operational Qualification (OQ) of the VACMASTER VP540 packaging

Project Name machine.

VP number VP-05-OCT-2020

Protocol number OQ-05-OCT-2020

1. Approval block:

Pre-approved by: Date

Konisbell Alcántara 01-OCT-2020

Yovanny Hernández 01-OCT-2020

Rubén Maríñez 01-OCT-2020

IIN311-N - Operational Qualification document
(OQ)

Samuel Ramírez 01-OCT-2020

Lauren Vásquez 01-OCT-2020

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 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 2 of 8

1.0 Purpose

This Operational Qualification (OQ) procedure will determine and challenge process parameters to ensure the output
of the equipment VACMASTER VP540 (ID-1008) packaging machine meets all defined requirements throughout the
anticipated operating ranges.

2.0 Scope

This Operational Qualification (OQ) is being performed because the ID-1008 is a new acquisition, so it falls under the
category of new tool qualification. Hence, it must be thoroughly studied and analyzed before including it in the
production line. Furthermore, the OQ will run a series of tests which ensure that equipment and its sub-systems will
operate within their specified limits consistently and dependably.

3.0 Equipment Description

The machine ID-1008 is designed as a commercial grade vacuum packaging system and can be used for a wide
variety of products. It allows the extension of food life, maintain food quality, reduce freezer burn and reduce food
waste and costs. The machine ID-1008 is a chamber vacuum system, which offers two distinct advantages over non-
chamber, external bag type units. First, a much higher level of vacuum can be achieved which means a longer shelf
life for foods packaged. Secondly, liquids and liquid-rich foods can be effectively vacuum packaged. Food products
like fresh meats, fish, soups, stews, etc. are no longer a problem to vacuum package. Marinated vegetables and
meats are packaged quickly with ease, and no mess.

3.1 Process Equipment Instruments

The following table lists the calibrated instruments installed in the equipment and their calibration ranges. The
purpose is to demonstrate that the equipment is properly calibrated according to the operating limits required by the
process.

Instrument Cal. ID & Parameter Process Calibration

Calibration Range
Description Controlled Range Date
Chronometer Vacuum Time 30 <-- sec --> 50 37 <-- sec --> 43 01-OCT-2020
Chronometer Cooling Time 1 <-- sec --> 5 1.8 <-- sec --> 3.2 01-OCT-2020

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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 3 of 8

4.0 Products within scope

The following list of products will be covered by this qualification:

Part Number / Specification

Description
Sub-assembly / dated
SN-5667 Black thread, USP size 4-0, length of thread 45 cm, needle type P-12. 01-OCT-2020

SN-5698G Black thread, USP size 5-0, length of thread 45 cm, needle type P-13. 01-OCT-2020

SN-5669 Black thread, USP size 3-0, length of thread 75 cm, needle type P-12. 01-OCT-2020

SN-5663 Black thread, USP size 3-0, length of thread 45 cm, needle type P-14. 01-OCT-2020

SN-5667G Black thread, USP size 4-0, length of thread 45 cm, needle type P-12. 01-OCT-2020

5.0 Materials
The following is a list of materials used in this protocol to manufacture product VACMASTER VP540:

Part Number Description Lot No.

75-0001 TELEFLEX - Nylon Monofilament Suture DR250825

75-0002 SRAG-WIESSNER- Needle DR260926

10-0001 PAKFACTORY – Display box DR271027

10-0002 LSO-INC – Pouch DR281128

10-0003 LSO-INC – Die cut backer cards DR291229

10-0004 Printronix Direct Thermal Media 205, 4x6 inches, Fan Fold DR301330

6.0 Product Critical Quality Attributes (CQA)

Document Document Title Document dated CQA to Evaluate

Tears other damages on the
123456 Damages on the suture 3-OCT-2020 suture that should
not be present.
Pouches must be sealed.
Seal Width
234567 Seal Width 3-OCT-2020 must be 0.38 inches.
Minimum 0.125
inches.

7.0 Critical Process Parameters

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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 4 of 8

7.1 Identification of Key Input Variables

The key input variables that are affecting the product area:
 Vacuum time
 Cooling time

7.2 Determination of Process Parameters

The worst conditions in which the equipment could work and still manufacture acceptable product are:

Parameter Low High

Vacuum time 8 10

Cooling time 2 4

8.0 Operational Qualification

Prospective qualification will be conducted on the equipment to challenge the worst operating conditions defined in
section above. Any material used in this evaluation will be properly destroyed.

8.1 Run Conditions

a) The number of protocol runs: 1,794.

b) The target process parameter setting: 0.38 inches.
c) Run size: 299.
d) Special environmental conditions: Do not use the VP540 on wet or hot surfaces, or near a heat source.
e) There is not any condition between runs.

Runs will be conducted to challenge the process parameters. Each validation run will be randomly sampled and
inspected at 95% confidence level. Table below shows the validation matrix combinations to be performed and the
size of each run:

Run Size or
Operating Parameters
Time running
Run Condition
Colling time Vaccum time N/A

1 High + + N/A

2 High + + N/A

3 High + + N/A

...299 High + + N/A

1 Low - - N/A

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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 5 of 8

2 Low - - N/A

3 Low - - N/A

...299 Low - - N/A

8.2 Line Clearance Verification

3.0 Run / Condition

Checklist item 1 / High 2 / High 3 / High 1 / Low 2 / Low 3 / Low

Is the line free of
Yes: Yes: Yes: Yes: Yes: Yes:
materials that will not be
No: No: No: No: No: No:
used for this OQ run?
Yes: Yes: Yes: Yes: Yes: Yes:
Are work areas clean?
No: No: No: No: No: No:
Is the area free of
identifications of raw Yes: Yes: Yes: Yes: Yes: Yes:
material that will not be No: No: No: No: No: No:
uses for this OQ?
Were the parameters set
Yes: Yes: Yes: Yes: Yes: Yes:
up according the run that
No: No: No: No: No: No:
will be executed?
Rubén Rubén Rubén Rubén Rubén Rubén

Verify Sign/Date Maríñez Maríñez Maríñez Maríñez Maríñez Maríñez

10/1/2020 10/1/2020 10/1/2020 10/1/2020 10/1/2020 10/1/2020

.

8.3 Quality Evaluation

The following quality evaluation will be performed to each run in order to evaluate conformance to release
specifications.

8.3.1 CQAs which generate attribute data

Attribute Data Evaluation per Specification 75-0002 dated 01-OCT-2020

Amount of
defects to Defects per
Item Description Type of Test Sample Size
Accept / Run
Reject
Run 1: 0
Damages on the suture Visual 0 299 Run 2: 0
Run 3: 0

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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 6 of 8

CONCLUSION: ☒ Acceptable ☐ Not Acceptable

Comments: Yes ☐ No ☒

Performed by: ___________________________________

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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 7 of 8

8.3.2 CQAs which generate Continous data

Continuous Data Evaluation per Specification 10-0002 dated 01-OCT-2020

Acceptance criteria type
☐ Values within specs
☒ Tolerance intervals
Type of Sample Specs Minimum Maximum
Item Description
Test Size limits observed observed
value or value or
lower upper
tolerance tolerance
interval interval
Run 1:
0.136 Run 1: 0.42
LSL: 0.125 Run 2: Run 2:
Seal Width Dimensional 299 inches 0.136 0.419
Run 3: Run 3: 0.42
0.135

CONCLUSION: ☒ Acceptable ☐ Not Acceptable

Comments: Yes ☐ No ☒

Performed by: ___________________________________

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
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(OQ)
 IIN311-N Rev: 2 Operational Qualification document (OQ) Page: 8 of 8

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

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

End of the document

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
IIN311-N - Operational Qualification document https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en
(OQ)