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Training handbook Client Vaxxas Project No. 180110_VAX Document number HBK001 Revision 01 © 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited. Page 1 of 14 [Document ID / Number]_r00 Course information Course title Quality by Design Course code PO1820 Trainer’s name Trevor Schoerie and Maria Mylonas
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Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 1 of 14 [Document ID / Number]_r00

Course information

Course title Quality by Design

Course code PO1820

Trainer’s name Trevor Schoerie and Maria Mylonas

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 2 of 14 [Document ID / Number]_r00

How to use this handbook

The handbook is organized to focus on skills and revisions. These lessons allow you to learn and practice the skills used throughout the course. The following icons are used in this handbook:

Activity Revision exercise or written task

Important Important points to remember for the assessment

Quick Link or Tip A shortcut, tip, or favourite link

Discussion Group discussion activity

This intellectual property remains the property of PharmOut Pty Ltd. It is intended for training purposes and its format and contents are copy written by ©PharmOut 2018. For further information go to www.pharmout.net

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 3 of 14 [Document ID / Number]_r00

Contents How to use this handbook ....................................................................................................... 2

Contents ................................................................................................................................... 3

1. The Perfect Cappuccino – Inputs and Outputs (QTPP)................................................... 4

2. The Perfect Cappuccino – Risk Assessment 1 ................................................................. 5

3. The Perfect Cappuccino – Control Strategy .................................................................... 6

4. The Perfect Cappuccino – Risk Assessment 2 ................................................................. 7

5. Preliminary Hazard Analysis (PHA) – Train Travel ......................................................... 8

6. Determining risk controls – PIP breast implants .......................................................... 10

7. Quality Risk Management (QRM)-Bungee Jumping ..................................................... 11

8. Cleaning Process CQA’S and CPP’s ............................................................................... 14

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 4 of 14 [Document ID / Number]_r00

1. The Perfect Cappuccino – Inputs and Outputs (QTPP)

In order to make the perfect cappuccino there are various inputs and outputs. The outputs can also be termed the Quality Target Product Profile (QTPP). In the space provided, list the inputs and outputs for a cappuccino.

INPUTS OUTPUTS / QTPP

Raw Materials

Equipment

Personnel

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited. Page 5 of 14

[Document ID / Number]_r00

2. The Perfect Cappuccino – Risk Assessment 1

Complete a risk assessment for making a cappuccino using the table provided. Risk rate each process stage against the inputs as Low (L), Medium (M) or High (H)

Processing stage Milk

Suga

r

Wat

er

Choc

olat

e

Coff

ee

bean

s

Cup,

Sau

cer,

Sp

oon

Gri

nder

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 6 of 14 [Document ID / Number]_r00

3. The Perfect Cappuccino – Control Strategy

What controls would you put in place in order to reduce the risk?

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited. Page 7 of 14

[Document ID / Number]_r00

4. The Perfect Cappuccino – Risk Assessment 2

Repeat the risk assessment for making a cappuccino assuming the control strategy is in place. Risk rate each process stage against the inputs as Low (L), Medium (M) or High (H)

Processing stage Milk

Suga

r

Wat

er

Choc

olat

e

Coff

ee

bean

s

Cup,

Sau

cer,

Sp

oon

Gri

nder

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 8 of 14 [Document ID / Number]_r00

5. Preliminary Hazard Analysis (PHA) – Train Travel

For this activity we will examine the hazards associated with getting on a train. Let’s just focus on hazards associated with the use of the train doors.

In relation to the train doors, what are the hazards associated with getting on a train? Use the table on the following page to record your answers:

• In the first column, list the hazard (potential source of harm) • In the second column, list the harm (the potential damage caused by the hazard) • In the third column list the control strategy

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 9 of 14 [Document ID / Number]_r00

Hazard Harm Control Strategy / Mitigation

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 10 of 14 [Document ID / Number]_r00

6. Determining risk controls – PIP breast implants

In 2013, the PIP breast implant scandal hit the news. Did the manufacturer determine their design controls properly? As the company executives were jailed for fraud, unfortunately risk control was probably not part of the product life-cycle. Read the following news excerpts and complete the table fields. The man who sparked a global health scare by selling breast implants containing industrial silicone was jailed for four years yesterday by a court in Marseille. Jean-Claude Mas, founder of Poly Implant Prothèse (PIP), was convicted of aggravated fraud. Four other defendants, former PIP executives or managers, were also found guilty and given jail sentences. The firm caused an international health scare when it was found that the faulty implants had been made with substandard and non-authorised material not fit for humans. At one time PIP was the third biggest global supplier of breast implants, used in an estimated 300,000 women in 65 countries. Some of the women were given the faulty implants during breast reconstruction operations after undergoing mastectomies as part of their cancer treatment. At their month-long trial in May the accused had admitted fraudulently using unapproved gel in the implants, at an annual profit of €1m, but Mas had denied it was harmful, while three of his co-accused said they were unaware of the possible dangers. http://www.theguardian.com/world/2013/dec/10/french-breast-implant-pip-jean-claude-mas-jailed

Complete the following table by proposing possible protective measures for equivalent implants manufactured by a responsible company.

Hazard Inherent safe design Protective measure

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 11 of 14 [Document ID / Number]_r00

7. Quality Risk Management (QRM)-Bungee Jumping

Perform a risk assessment on Bungee Jumping. • Complete the FMEA Table • Work in groups

Risk Priority Number (RPN) RPN = S x O x D

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited. Page 12 of 14

[Document ID / Number]_r00

Process Step (A)

Potential Failure Mode (B)

Potential Failure Effects

(C)

Sev (D)

Potential Causes (E)

Occ (F)

Current Controls (G)

Det (H)

RPN

What is the stage or step(s)?

In what ways can the process step or input fail?

What is the impact on the key output variable once it fails?

What causes the key input to go wrong?

What are the existing controls and procedures that prevent the cause or the failure mode?

E.g Cord Cord is too long Serious injury or death 3 Incorrect calculation by operator

1 Second check of calculation by another operator

2 6

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited. Page 13 of 14

[Document ID / Number]_r00

Process Step (A)

Potential Failure Mode (B)

Potential Failure Effects

(C)

Sev (D)

Potential Causes (E)

Occ (F)

Current Controls (G)

Det (H)

RPN

What is the stage or step(s)?

In what ways can the process step or input fail?

What is the impact on the key output variable once it fails?

What causes the key input to go wrong?

What are the existing controls and procedures that prevent the cause or the failure mode?

Training handbook

Client Vaxxas Project No. 180110_VAX

Document number HBK001 Revision 01

© 2018 PharmOut. This document is uncontrolled when printed. This document has been prepared solely for the use of PharmOut and its clients and copying is prohibited.

Page 14 of 14 [Document ID / Number]_r00

8. Cleaning Process CQA’S and CPP’s

CQA’s

CPP’s

DOCUMENT END


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