quality - gmp · quality - gmp contractor handbook self paced learner’s resource version 001

Quality - GMP

Contractor Handbook

Self Paced Learner’s Resource

Version 001

Quality – GMP Contractor Handbook Self Paced Learners Resource

Version 001 © Copyright Blood Service

Publisher

Australian Red Cross Blood Service

Level 3

417 St Kilda Road

Melbourne, Victoria 3004

Acknowledgements

Instructional Designer: Val Conduit

Subject Matter Expert: Rosalie Evans

Additional Contributors: Fiona Gamble

© Australian Red Cross Blood Service, December 2012

All rights reserved. Except under the conditions described in the Copyright Act 1968 of Australia and

subsequent amendments, no part of this publication may be reproduced, stored in a retrieval system or

transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without

the prior permission of the copyright owner.

This resource was produced by the Australian Red Cross Blood Service to be used as resource material.

Disclaimer

Every effort has been made to ensure that this booklet is free from error or omissions. However, you should

conduct your own enquiries and seek professional advice before relying on any fact, statement or matter

contained in this book. The Australian Red Cross Blood Service is not responsible for any injury, loss or

damage as a result of material included or omitted from this course.

Information in this resource is current at the time of publication.

Version Control

Version Number Date Obsolete Date Effective Change Summary

001 Not Applicable

24th December 2012 New document


© Copyright Blood Service Version 001

Table of Contents

Table of Contents...................................................................................................................3

Introduction............................................................................................................................4

Purpose of this workbook ....................................................................................................................................4

Learning Map.......................................................................................................................................................5

Learning Outcomes .............................................................................................................................................5

Duration ...............................................................................................................................................................5

Reference ............................................................................................................................................................6

Definitions ............................................................................................................................................................6

Good Manufacturing Practice (GMP) as a Contractor at the Blood Service.....................7

Introduction ..........................................................................................................................................................7

Training ................................................................................................................................................................7

Contractor Rights and Responsibilities...............................................................................8

Rights...................................................................................................................................................................8

Responsibilities....................................................................................................................................................8

Confidentiality ......................................................................................................................................................8

Blood Service Security..........................................................................................................8

Records and Documentation ................................................................................................9

Signature Register ...............................................................................................................................................9

Completion of Records ........................................................................................................................................9

Examples .............................................................................................................................................................9

Equipment Maintenance......................................................................................................10

Pest Control .........................................................................................................................10

Control of Materiel ...............................................................................................................11

Cleaning................................................................................................................................11

Spills ..................................................................................................................................................................12

Hygiene.................................................................................................................................12

Personal Hygiene ..............................................................................................................................................12

Summary ..............................................................................................................................13

What’s Next? .....................................................................................................................................................13

Evaluation.............................................................................................................................14



Introduction

Purpose of this workbook

This workbook includes all the materials and activities needed for you to complete the Quality GMP Contractor

module.

How to use this workbook

Self Paced Learning

This module is self-paced which means that you will be able to complete the module unaided. The workbook contains

a series of topics. Each topic contains a mixture of reading, activities and learning checks which are explained below.

Activities

The module contains several activities that will enable to you to interact with what you are learning. Applying the

knowledge you obtain in and through the activities will assist you well in retaining what you have learned.

For optimal conditions while you are learning, make sure you have a comfortable, quiet place to learn

How to get help

Sometimes its tricky learning on your own, so if you need assistance please contact your SCA on site. Your SCA will

provide you with their location and contact details if you should require assistance. Please record it in the space below

for handy reference.

Blood Service Contact Name

Blood Service Contact Location

Blood Service Contact Phone



Learning Map

This module is an integral part of your program. The diagram below is a map to show you where you are in your

program.

You are here Module 2: Quality – GMP Contractor Handbook Self Paced Learners Resource

Module 1: Contractor Handbook

Learning Outcomes

Upon completion of this module you should be able to:

•••• Describe your responsibilities when working at a Blood Service site in regard to GMP.

•••• Describe the way you work and what you do on a Blood Service site and how it affects the quality of Blood

Service blood products

•••• Explain how contractors take care to ensure that appropriate cleanliness is achieved so that the blood, blood

products and staff are protected from contamination by the environment

Duration

This module will take 30 minutes to complete.



Reference

ARCBS-NLD-L3-225 Quality – GMP for Contractors – Assessment Resource

ARCBS-OHS-L3-018 Contractor Orientation Checklist

ARCBS-NAT-OHS-L3-019 Contractors Handbook

Definitions

Blood Service The shortened reference to the Australian Red Cross Blood Service.

Blood Service Site

Manager

The Blood Service Manager who monitors the contractor on site.

Compliance Work practices performed in accordance /compliant to the Code of GMP,

Blood Service procedures and policies

Contractor’s Agent An individual or agent performing contracted work on behalf of the external

contractor/service provider.

Contract Owner The contract owner is the manager of the department or site at which the

service is provided or the person responsible for the central administration of

a contract that applies to multiple sites.

Critical Materiel All Components, materials or supplies which could have a direct negative

impact on the quality of the end product.

External contractor/

Service Provider

An external contractor/service provider is any company or individual who

undertakes, under contract or agreement, to perform work on behalf of the

Blood Service.

GMP Is the short reference to Good Manufacturing Practice (GMP).

OH & S The short reference to Occupational Health and Safety.

SOP Refers to the Standard Operating Procedure used as an instruction to

complete a task or repair job.



Good Manufacturing Practice (GMP) as a Contractor at the

Blood Service

Introduction

Welcome to the Australian Red Cross Blood Service!

At the Blood Service we believe that our suppliers become our partners in providing quality blood and blood products for those who need them.

The blood we collect and process is done so according to Standard Operating Procedures, by trained staff and to a code of practice. This code is called the Australian Code of Good Manufacturing Practice – Human Blood and Tissues and is also known as the code of GMP (cGMP).

The code requires all staff, including those of contractors, to be trained in the principles of GMP.

We hope by the end of this GMP Contractors Handbook that you will have a better awareness of how the service you provide may affect the quality of our products and an understanding of your responsibility in regards to the cGMP.

Training

It is necessary for contractors and personnel working on a Blood Service site to be trained in accordance to the job and, to be competent in the entire task they are performing when on a Blood Service site.

An assessment, evaluation and authorisation form will be given to you with this handbook. The Blood Service requires you to complete the assessment form. Your supervisor is then required to send the assessment back to the Blood Service.

This assessment becomes part of the Blood Service training records and will ensure our compliance to the cGMP.

Where a contractor’s agent has not yet undertaken GMP for Contractors awareness training they must be supervised by the Blood Service personnel whilst on premises.

A record acknowledging completion of this GMP Awareness training will be retained by the site or department with whom the contractor has most contact.

Good Luck to you all and Welcome to the Australian Red Cross Blood Service.

AUSTRALIAN RED CROSS BLOOD SERVICE

QUALITY TEAM



Contractor Rights and Responsibilities

Rights

All contractors and staff have the right to work in safe environment, free from offensive, humiliating or intimidating behaviours. They have the right to be treated fairly and without prejudice or discrimination.

Responsibilities

The external contractor/service provider is responsible for ensuring that personnel performing contracted work have undertaken GMP for Contractors training and that records of the training are maintained. In order to ensure that a high level of professionalism is maintained, both staff and contractors must be aware of the responsibilities they have in their roles.

Confidentiality

All contracted/service provider staff are required to treat any information acquired or viewed, during the course of their work at the Blood Service as strictly confidential. All self-employed contractors, subcontractors and their staff are subject to the confidentiality and non-disclosure agreements.

Blood Service Security

All contractors visiting a Blood Service site are required to sign the visitors register book upon arrival and departure. All visitors MUST obtain a visitors label which must be worn at all times while on Blood Service premises. A contractor requiring after hours access must be GMP competent prior to receiving a security access pass. When accessing a Blood Service site after hours, the contractor must notify their Blood Service Site Manager of their arrival. In some instances, contractors will be given security passes or similar which will allow them access to restricted areas, as required.

External doors must never be left open and unattended. In addition, some internal doors are secured at all times and swipe card access controlled..

These areas include:

• Laboratories and Processing areas

• Inventory and Distribution areas

• Information Services & Record Storage areas



Records and Documentation

External contractors and service providers are required to follow approved and current Blood Service documented procedures and complete Blood Service records. Contractors are not permitted to make changes to these procedures without the consent of the Blood Service. It is essential that contractors read and understand these documents prior to performing work for the Blood Service.

If there are procedural differences between a Blood Service procedure and a document the contractor normally follows, the Blood Service procedure takes priority.

Signature Register

Prior to performing work for the Blood Service you will be asked to add your name and signature to the Signature Register, which is a form used to identify signatures on contractor documentation. This register need only be completed once, with the following exception.

If you change your name you must notify the Blood Service and complete another signature register.

Completion of Records

When you visit a Blood Service site and provide a service (e.g. cleaning, pest control etc.) a record is required. When the form is completed details must show what has been done, when it was done and by whom. These forms are known as Records and provide proof that the service was provided to the agreed standard of quality.

It is important that these records are complete, legible and that these service records are provided to the Blood Service Site Manager or delegate for checking and verification prior to you leaving the Blood Service site. The integrity and clarity of records is essential in a GMP environment therefore there are a number of stipulations in how records are to be completed.

• Blue and black pen only are acceptable when completing Blood Service records.

• All sections on the record are to be completed, or recorded as ‘Not Applicable’. You may also rule a diagonal line across the not required section of a form.

• Where an amendment is to be made to information on a record, the original incorrect information must be legible and no entry on a record is to be covered up or obliterated in any way. The correct way to amend an incorrect entry is:

• draw a single line through the incorrect entry, never ‘overwrite’ or use ‘white out’,.

• Record the new entry as close as possible to the original

• initial and date the correction(s).

Examples

1. wooden

metal JS 01/10/11

2.



Equipment Maintenance

Rigorous selection criteria are applied to all equipment used by the Blood Service and any change to the equipment and its intended use, may impact on the quality of the Blood Service products and services.

All Blood Service equipment must be maintained and (where applicable) calibrated according to the manufacturers specifications. Where the equipment is owned by the contractor, any maintenance and repair is the responsibility of the contractor.

The Blood Service undertakes a preventative maintenance approach for our equipment (both general and specialised equipment) ensuring continuous operation of our equipment.

Where contractors are engaged to maintain or service Blood Service equipment,

there are specific record keeping requirements to be observed. These records are located at each

Blood Service site.

Servicing and repairs must be completed by a suitably qualified person, for example a registered refrigeration electrician attending to servicing Blood Service freezer equipment and; serviced, repaired and maintained in accordance with the manufactures recommendation or Blood Service requirements. A record of all testing, maintenance, servicing and repairs must be completed and a service report provided to the Blood Service as soon as possible. This service report is required as it is a record of the maintenance or service performed.

Pest Control

Regular pest control keeps the site free of vermin and other pests, which could render the blood and blood product unsafe. Furthermore, regular pest control helps to ensure that critical paper records, etc. are kept safe.

For all Blood Service staff and contractors it is essential that you DO NOT allow rubbish to accumulate. Rubbish must be appropriately bagged before being removed from a Blood Service site. Removal of rubbish will assist with the maintenance and control of pest.

For Principle Sites, Inspection \ Treatment may occur on a regular basis. Inspection \ Treatment is also carried out in accordance with pest control standards and schedule (or if evidence of infestation exists). The areas, type of treatment required and the inspection frequencies are listed in the local specifications. A copy of the local specification will be kept on-site and another copy will be issued to



the pest control contractor(s). It will be the responsibility of the contractor to make available these documents to all their staff as and when required for the effective conduct of their duties.

Control of Materiel

Due to the highly sensitive nature of blood components and the manner in which they are used, the Blood Service seeks to ensure that chemicals which may contaminate our products are excluded from the work environment or handled in a safe manner. Any chemical to be used by contractors in a manufacturing area at the Blood Service must be approved by the Blood Service before use. This is to ensure that the material used in the collection, preparation, testing and storage of blood and blood components are of an appropriate nature to guarantee a high-

quality end product. Your materiels may have an unexpected affect on our products and process

Remember it is important to only use chemicals in a manufacturing area that have

been approved by the Blood Service

Sometimes chemicals used by contractors need to be decanted (from a larger bottle to a smaller bottle),

or diluted. Where this is necessary, the bottles must be labelled appropriately. A label must be placed on

the bottle which shows the date of preparation, the date of expiry, and must be signed by the person

preparing the solution.

Cleaning

The Blood Service has a cleaning and sanitation program that is designed to reduce the risk of blood contamination by bacteria, viruses, fungi and other non-microbial contaminants.

As part of this program, the Blood Service requires that all contractors must take care to ensure that appropriate cleanliness is achieved so that the blood, blood products and staff are protected from contamination by the environment.

Cleaning staff, including casual or temporary personnel shall receive appropriate training and instructions in the cGMP as it applies to provision of cleaning services.

Premises cleaning is performed based on the activities described in the local site specification. A copy of the local specification will be kept on-site and another copy will be issued to the cleaning contractor. It is the responsibility of the contractor to make available these documents to all their cleaning staff.



Spills

Spills can occur in all work areas and may involve a variety of types of materials including blood, beverages, chemicals etc. They could affect your health and safety and product safety either directly (due to contact with bare skin or released fumes) or indirectly by leading to slips and trips.

IF YOU FIND A SPILL:

1. Immediately sign post the spill area and,

2. Contact your Blood Service Supervisor or Delegate

Hygiene

THE CODE OF GOOD MANUFACTURING PRACTICE REQUIRES THE BLOOD SERVICE TO

ENSURE THAT GOOD PERSONAL HYGIENE PROCEDURES/PRACTICES ARE

UNDERSTOOD BY ALL STAFF AND CONTRACTORS.

Personal Hygiene

• Maintain a high level of Personal Hygiene

• Notify your Blood Service Site Manager of any illness and the associated

possibility of blood contamination

• Wash your hands thoroughly after using or cleaning toilets.



Summary

Thank you for taking the time to thoroughly read this Handbook.

You should now be able to:

• Describe your responsibilities when working at a Blood Service site in regard to GMP.

• Describe the way you work and what you do on a Blood Service site and how it affects the quality

of Blood Service blood products

• Explain how contractors take care to ensure that appropriate cleanliness is achieved so that the

blood, blood products and staff are protected from contamination by the environment

If during your work at the Blood Service you have any immediate concerns please contact your Blood

Service Site Manager.

What’s Next?

When you have finished reading this document you will be given an assessment and authorisation form

to complete. Your supervisor will send it to back to the Australian Red Cross Blood Service where we will

mark the questions and file the assessment as part of Recordkeeping requirements. You will be notified of

the outcome of the assessment

Please ensure that you sign the Assessment documentation. Please record your signature as per the

signature register in the field marked – Candidates Signature.

The contractors’ signature indicates that you have read, understood and

completed all applicable documentation \ activities. It also indicates that you,

the contractor, accept that compliance with the rules contained in the GMP

Contractor Handbook as a precondition for permission to work on a Blood

Service site.

At the end of this document is an evaluation form about the GMP for Contractors Handbook. You are

not required to complete this form however if you would like to see changes to this documentation or

improvements to this training program, please complete the form and return to the address nominated

on the form.

THANK YOU!


Evaluation Sheet: Quality – GMP Contractor Handbook

Evaluation

The aim of this questionnaire is to collect your feedback on the module you have just completed. The data

gathered will be used to improve the course materials.

If you are willing for us to follow up with you, please complete your contact details below:

Name:

Contact Number:

Contractor role:

Date:

When this form is completed, please return to:

Australian Red Cross Blood Service

Learning and Development

Quality Design Consultant

Level 3, 417 St Kilda Rd,

Melbourne, Victoria, 3004

.Experience

Please complete the following questions regarding your experience.

1.) Are there any other topics you would like to have seen included in the course/module?

2.) Have you any further suggestions for improving the course/module?

3.) What did you like most about the training?

4.) Any other comments?

Thank you for your time – your feedback is very much appreciated.

quality - gmp · quality - gmp contractor handbook self paced learner’s resource version 001

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