Sample Answers Answer 2: Applying Information types · Sample Answers Answer 2: ... escalate the situations with myself if you ... ‘We ask for your continued commitment to ensure

Training handbook

Client NZBS Project No. 171022_NZBS

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 TRG_TMP650_05_r04

Sample Answers

Answer 2: Applying Information types

Item Description Information type Suggested

document type

1 The overall process for management of

inwards goods. Process Procedure

2 Step by step instruction on how to

complete a transaction in SAP. Instruction Work instruction

3 Site access rules for swipe cards. Rule

Policy and/or

procedure

4 Diagram of a filling machine. Structure

Procedure and/or

work instruction

5 Instruction of equipment set-up. Instruction Work instruction

6 Over view of the inwards good process. Process Procedure

8 Description of the validated layout of

equipment in an autoclave. Fact

Procedure and/or

work instruction

9 A list of equipment settings. Fact

Procedure and/or

work instruction

10 GMP. Concept

Procedure and/or

work instruction

and/or policy





Answer 9: Apply the 7+2 rule

No Sub-heading suggestion

1 Prepare for assembly (Steps 1-3)

2 Set-up the wheels (Steps 4-7)

3 Set-up the brakes (Steps 8-12)

4 Attach the pedals (Step 13-17)

5 Pump up the tyres (Step 18-20)

6 Set-up seat and handle bar heights (Step 21-25)

7 Prepare for assembly (Steps 1-3)

Answer 10. Keep it simple

From: ‘Your continued efforts and commitment to meeting these challenges ensuring we deliver on the revised dates are sought by management. If you encounter any issues that are inhibiting you from achieving your individual tasks then please raise these with your team leader promptly and, if need be, escalate the situations with myself if you believe they are of such significance or causing you significant frustration.’ To: ‘We ask for your continued commitment to ensure that the revised dates are met. If you have any problems, please contact your team leader, or raise significant issues with me.’





Answer 11: Writing in the active voice

1. In the event that the VeryClever analysis program is unavailable, manual analysis tables

are available in the kit inserts supplied.

Your answer:

Use the manual analysis tables in the kit inserts if the VeryClever analysis program is unavailable.

2. Clicking on specific positions within the gel image allows those bands that are

recognised by this reference standard to be made visible.

Your answer:

Click on specific positions within the gel image for the bands within this reference standard to become visible.

3. The number of tolerances may be adjusted using the ‘tolerance window”. Clicking on the

“FIND” will highlight the allele specificities of the SSP with the conflicting result. You

must write the result on the donor record.

Your answer:

Adjust the tolerances using the ‘tolerance window’:

• Click on Find to highlight the allele specificities of the SSP with the conflicting result

• Write the result on the donor record.

4. Each row of the scanned gel should be labelled with the reference or batch number, and

the date.

Your answer:

Label each row of the scanned gel with the reference or batch number and date.





Answer 12: Using tables, bullets and numbers

Stage Description

1 Apply the following guidelines when writing an SOP:

• Include a clear Scope on the first page.

• Write the process in sequence.

• Ensure you update the Change History on the last page.

2 Forward completed documents for final approval by the:

1.Preparer.

2.Verifier.

3.QA Approver.

3 The Quality Systems Documentation Coordinator will:

1.Upload the approved document.

2.Organize hard copy distribution.

3.Recall the superseded version.





Answer 16: Document Review

Information type: Process

Suggested document type: Procedure

Why: It is a series of stages performed over time, by different people.

Process map: See Procedure overview section below. This provides a general break-down of the steps in this process.

Note: In this activity, the goal was to provide a high-level process map, and to write the first few steps of the procedure. I have included the purpose, scope, out of scope, roles and responsibilities for information. You would probably need more information about the process to complete this procedure/activity properly.

Purpose

The purpose of this SOP is to describe the requirements for conducting maintenance on packaging machines/equipment.

Scope

The scope of this SOP includes:

packaging machines/equipment performance, breakdown and reliability issues.

Out of scope

The following are out of scope for this SOP:

dispensing machines/equipment (refer to XXXX)

filling machines/equipment (refer to XXXX)

etc.

Roles and responsibilities

Role Responsibility

Packaging operator Notifies Team Leader (or delegate) of any performance, breakdown and

reliability issues.

Team Leader (or

delegate)

Assesses impact of maintenance issues, and determines the appropriate

actions to be taken.

Notifies maintenance of maintenance issues.

Raises work orders.

Maintenance Conducts maintenance activities.





Procedure overview

**Note that this could be broken down further if there was more information available for each step but I have kept it very simple.

Section Description

1 Report maintenance issue

2 Complete maintenance activities

1. Report maintenance issue

Packaging operators notify a Team Leader/delegate of equipment/machine performance, breakdown and/or reliability issues.

The Team Leader (or delegate):

assesses the potential impact of the issues and determines the appropriate action

notifies the maintenance fitter or maintenance supervisor of the issue

raises a work request as per SOP-3719.

2. Complete maintenance activities

Maintenance personnel:

complete maintenance activities (as per work order)

document all maintenance activities and corrective actions in accordance with SOP-11039 or SOP-11147.

The Team Leader/delegate provides guidance to maintenance personnel (where required) to ensure that product quality is not impacted.

At the completion of maintenance activities, maintenance personnel reconcile all tools used.





Examples

1. SOP process overview table





2. Referencing

Good example of referencing associated and directly referenced documents.





3. Using if/then

An example of using if/then tables to show complex actions.





4. Details in a change history table

An example of detail in a change history table





5. Details in a roles and responsibilities

An example of detail in the roles and responsibilities table. Note this information should not duplicate process information later tin the SOP.





6. Bilingual examples

Blended form

Good example of blended form.





7. Example of poor biligual formatting

Process flow broken, confusing for end user to read which impacts training and retention.





8. Example of parallel formatting for a bilingual process

Parallel formatting allows each user to read the process without interruption. This formatting style improves useability and therefore assist with training and retention.

DOCUMENT END

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Sample Answers Answer 2: Applying Information types · Sample Answers Answer 2: ... escalate the situations with myself if you ... ‘We ask for your continued commitment to ensure