Innovation, Creativity, and Entrepreneurship in Academia: A Review

Abstract

This overview complements our two previous reviews on the future of Arab universities and on quality assurance and relevance in academia published in this Springer book series. It encompasses the concepts of universities and their societal roles, and considers the definitions of innovation, creativity, and entrepreneurship. It argues that innovation and entrepreneurship can be taught in the right circumstances. The personal qualities needed to be an entrepreneur are described. An account is given of intellectual property (IP), especially patents and copyright works, together with its regulation in different jurisdictions, registration, defence, and exploitation. Governments have a pivotal role in facilitating start-up companies and the ease of conducting business. Also important is their interaction with international bodies such as the World Trade Organization and Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Organisation for Economic Co-operation and Development, World Intellectual Property Organization etc., and international indices such as the World Competitiveness Index. Governments can assist this crucial phase of university development, but should not interfere with universities, by a combination of adequate education and research funding together with setting up national technology foresight and related exercises, participating in regional initiatives to establish large-scale research and development facilities, and promoting competition. The combination of quality assurance, societally relevant teaching and research, accreditation, university-based and university-associated business and technology parks, business incubators and similar structures, alongside business schools, represent the main routes to successful delivery of university-derived IP. Even so, much depends on the quality, energy, experience, attitudes, and contact network of those leading these structures, and those of the associated academic staff. The roles of banks, venture capitalists, business angels, IP lawyers, and accountants in establishing a business are described, and the role and design of business plans outlined. Worrisome aspects of IP theft are described although there is little prospect of preventing it at this juncture in international relationships. Opportunities arising from the raft of transformative technologies under development are described, along with opportunities arising from international trends in convenience, fashion, design, entertainment, and diet. Climate change and the problems of water, energy, and food security offer huge opportunities for university-based innovations in STEMM subjects (science, technology, engineering, mathematics, medicine). Challenges come from (a) the level of competition; (b) dominating position of the US and Chinese tech giants absorbing talent and finance; (c) venture capital based mainly in the US and Europe; (d) US Supreme Court ruling on the patentability of software; and (e) problems of doing business in the Arab world and its attitudes to R&D and innovation. The overview ends with guidelines on establishing a business or company, and special features to consider when doing so in the Arab world. An appendix details advice for IP guidance for staff and students, plus supplements to institution-supplied laboratory and other notebooks with instructions for (a) record keeping required for accreditation and IP litigation; (b) code of institutional practice; (c) institutional quality plan; (d) standard operating procedures; and (e) equipment logbooks.

Appendix: Advice to Higher-Education Institutions on Research and Work Records with Regard to Quality Assurance and Intellectual Property

This advice is for institutions yet to embark on QA and accreditation processes, and wishing to promote innovation that can lead to the generation of IP. It is more applicable to STEMM subjects but aspects could be usefully adopted in other areas of academic practice, especially when considering copyright. We thank colleagues at the James Hutton Institute (formerly Scottish Crop Research Institute and its commercial arm Mylnefield Research Services Ltd.), Dundee, UK, for development of this advice.

In order to implement the following QA and IP measures, the institution has to be able to:

• Accept the guidance of the World Intellectual Property Organization [15]

• Establish an Intellectual Property Policy [e.g. 16b]

• Produce a Code of Practice for conducting research

• Produce a Health and Safety Policy

• Develop a Quality Plan, appoint a Quality Manager, and Quality Representatives in each work area

• Start to engage with international accreditation organisations

• Prepare Confidentiality Agreements for dealing with third parties

• Supply new official Notebooks and securely store used Notebooks

• Include in the Notebooks instructions and guidance notes for making and maintaining research records, Standard Operating Procedures, and equipment logbooks

• Maintain a record in the asset registers of institutional IP (mainly patents and copyright) and valuable uncommon skills and know-how. These details will be invaluable in future QA and relevance assessments

Example of Guidance on Intellectual Property for Employees and Students

We thank the University of Leicester, UK, for this example [16].

The University owns all intellectual property (IP) or other materials developed by its employees, unless explicitly stated otherwise. In exchange, the University provides generous revenue sharing schemes for employees and their departments, should the IP be commercialised. The University does, however, waive copyright of academic outputs such as theses, journal articles, books, or book chapters.

Students are not employees of the University and therefore legally own any IP arising from their research as long as all of the creative intellectual input has been that of the student. When students have simply followed a supervisor’s instructions, the intellectual input resides with the supervisor. Where the research results are clearly the output of intellectual input from both the student and supervisor then, depending on the particular circumstances, the intellectual input is jointly owned by the student and the University or each owns any IP that results from their respective creative inputs, subject to the individual circumstances of each research activity.

When a researcher is both a student and an employee (e.g. a graduate teaching assistant, an undergraduate doing hourly paid work, or a member of staff taking a part-time undergraduate, postgraduate taught or postgraduate research degree), ownership of IP will normally be determined by whether the IP was created during the researcher’s duties as a member of staff or a student.

The University will decide, on a case-by-case basis, whether students should assign their IP to the University. Supervisors are responsible for ensuring that the appropriate documentation for executing such an assignment is signed in conjunction with Administration. On assigning their IP to the University, students will benefit from the University’s exploitation policy on the same terms as employees.

Where funding (cash or in-kind) is received from an external body, there may be agreement that the sponsoring body has rights to ownership of IP arising from the project. The supervisor of such research is responsible for ensuring that the appropriate assignments of ownership are in place between any student and the University.

The University’s IP Policy sets out the procedures to be followed should an invention or discovery be made in the course of a research project carried out as part of normal University activities. It is essential that the Administration be contacted at an early stage to obtain advice and guidance. Staff and students must be aware of the need to maintain confidentiality regarding the results of research, pending legal protection, in accordance with any instructions or advice from Administration.

There is a range of ways in which confidentiality can be compromised by disclosure of information including a discovery or invention. Disclosures may occur as a result of posters, presentations, emails, informal conversations, etc., in addition to published papers. Breaches of confidentiality may result in actions for recovery of losses from a research funder or external collaborator against the University and the individual concerned, together with a loss of income. Even if a research funder is not involved, breaking confidentiality will result in an inability to protect the IP at any time in the future. It is possible to have confidential conversations without compromising IP under the protection of a confidentiality agreement; such agreements can be prepared by Administration.

On leaving the University, any IP developed during employment that is owned by the University, or by any research funder to whom such IP has been assigned in accordance with a relevant contract or licence, remains the property of the University or funder. It should not be divulged to third parties without the permission of its owner, unless it is already in the public domain.

Where research involves collaborative working with individuals and organisations outside the University, any protectable IP developed by collaborators will be handled as agreed in the research contract. If the research contract contains a confidentiality clause, it may be possible to disclose the details of the IP to all of the collaborators; otherwise it will be necessary to keep the details to those deemed ‘inventors’.

Researchers must ensure that they do not divulge information received from a third party under terms of confidentiality without written permission, as to do so may render them liable to claims by the owner of the information. Such restrictions are very likely to persist beyond the end of a research project.

General Comments for the Institution

At first, some staff can find the quality processes excessively bureaucratic, and they are undoubtedly difficult for lone individuals lacking knowledgeable colleagues in an organisation. We found that, with practice, most staff soon adapt to the quality environment. Sponsors, grant-awarding bodies, and contracting organisations welcomed the new measures. Staff became more conscious of the processes needed to generate IP. Special arrangements have to be made for isolated colleagues.

Institutional Notebooks needed for Intellectual Property Protection

• The institution should issue official record-keeping books, especially laboratory notebooks, recording on the first page the name of the institution, the notebook number, and to whom and when it was assigned. The institution should keep details of the notebook number, the assignee, and the date

• When completed, the notebooks should be returned to the institution at an appropriate time for safe keeping

• The notebooks should have numbered pages so that removal of pages can be detected

• Printed instructions for making and maintaining records should follow the first page and terminate with a statement that the instructions have been read and understood for signing and dating by the assignee

• The instructions should be followed by a table of contents

• Thereafter, every page should have a long slender heading comprising the name of the institution, a small box for entering the name of the project (or study), and another box “continuing from page” for linking discontinuous projects. At the base of each of these pages, there should be long slender box titled “Read and understood by” with two “signed” and accompanying “date” boxes (for independent witness countersigning) and another box for entering “continued on page”

• At the end of the book should be four appendices. These comprise an institutional Code of Practice, the institutional Quality Plan, Standard Operating Procedures, and Equipment Logbooks

Printed Sections in the Notebook

• A. Instructions for Making and Maintaining Research Records

• B. Code of Practice

• C. Quality Plan

• D. Standard Operating Procedures

• E. Equipment Logbooks

1.1 A. Instructions for Making and Maintaining Research Records

1.1.1 Introduction

When completed, this notebook should provide a sufficiently complete record of your laboratory (or other work) to be understood and repeated by yourself and others. The following procedures for record creation have been designed to meet the requirements of the institution’s Intellectual Property (IP) Policy, and laboratory accreditation to international standards (e.g. ISO 900, the OECD principles of Good Laboratory Practice). The design of the notebook affords maximum protection of your IP. To fulfil the requirements of accreditation and to give the notebook value as a legal document in possible IP litigation, the following practices must be followed.

1.1.2 General Requirements for Record Creation

1.1.2.1 Entry of Records into the Notebook

Written records must be indelible, so all records must be made with permanent ink, not pencil or washable ink. The date should be noted on every completed page.

1.1.2.2 Alterations

Alterations to written records are made firstly by crossing out with a straight line through the existing incorrect words, phrases, sentences, or paragraphs. Do not erase or obliterate incorrect entries. Do not use correction fluid or remove pages. The correct entry should then be added alongside or as near as possible using a note giving the location of the correction. In both instances, the correction should be initialled and dated. An explanation of the correction should be added if relevant.

1.1.3 Content of Records

1.1.3.1 Adequacy of Information

Sufficient information about materials, procedures, reagents, apparatus, diagrams, conditions, references etc. should be recorded. Entries should be made as the work is done using the past tense. Where such details are contained in existing documented methods, such as Standard Operating Procedures (SOPs) etc., then make reference to them. Scans, spectra, films, photographic series etc. should be signed and dated, and if they cannot be permanently attached to the notebook, their location should be recorded in the notebook,

1.1.3.2 Entries

Entries in the notebook should state clearly the purpose and importance of the work in addition to any results, observations, and conclusions. An apparently trivial observation may prove to be of critical importance at a later date. Entries should be sufficiently clear and complete so that another person with the necessary expertise can read and understand what has been done. Sweeping negative statements (e.g. “This procedure is of no use.”) should be avoided because they could later limit the scope of your claims. If a page of the notebook (remembering to use both sides of the pages) is not filled in completely or left blank, then a diagonal line should be drawn across the blank section.

1.1.3.3 Abbreviations and Technical Terms

All non-standard abbreviations and terms should be defined. A table should be made in the notebook for this purpose. If another person does some of the work, the data obtained by that person should be recorded in the notebook as soon as the data are received and the person must be identified. When not in use, the notebook should be kept in a secure location.

1.1.4 Specific Requirements for Patent Protection

1.1.4.1 USA Is Different

For patent purposes, there are various requirements for an invention

• (a) In the UK and most other countries except the USA, priority of invention is determined by the “first to file” system. There are four prerequisites for a patent: (i) novelty (i.e. first to file a patent application); (ii) inventive step; (iii) industrial applicability; and (iv) not a statutorily excluded subject.

• (b) In the USA, priority of invention is determined by the “first to invent” system. There are two requirements for an invention: (i) date of the invention; and (ii) demonstration that the invention works, i.e. “reduced to practice”.

1.1.4.2 Witness

The requirements above must be corroborated by a witness; the unwitnessed records or notebooks of the inventor(s) are insufficient. Dates and witnesses can help establish priority of invention and is of particular importance in the USA. Every notebook page should be read, witnessed, and dated – regularly – by somebody who understands the work, but does not claim to be a co-inventor. Completed graphs, figures, and tables should be signed and dated by the witness, Tables should have lines drawn through any blank spaces prior to witnessing. Changes made after a page has been witnessed should be initialled and dated by the inventor and the witness.

1.1.5 Intellectual Property Rights

1.1.5.1 Security

The notebook and its contents are highly confidential and can be of great value when seeking IP protection. The loss or theft of a notebook should be reported to the line manager or supervisor immediately.

1.1.5.2 Role of the Institution

The notebook and its contents are the property of the named institution. Under normal circumstances, it is forbidden to copy, transmit, or disclose the contents of the notebook to any third party without the express permission of the line manager, supervisor, or their nominated representatives.

1.1.5.3 IP Ownership

The contracts of employment and staff codes, and the stated relationship between the institution, supervisor, employee, and student should details the rights and responsibilities of the parties with specific reference to information, all forms of IP, discoveries, and creations.

1.1.5.4 Record-Keeping Practices

Research and other similar records must be kept in accordance with the practices detailed above if they are used to gain IP protection. Even if the work contained in the notebook does not result in IP applications, observance of these practices will provide a clear record for reports, publication or future reference.

1.1.6 Confirmation by Assignee

The signature and date of the assignee is required to confirm that the above instructions have been read and understood.

1.2 B. Code of Practice

1.2.1 Introduction

The institution has a global reputation for conducting research of the highest quality. It adopted the following Quality Policy.

• It is dedicated to achieving and maintaining the highest possible standards of quality in order to meet the needs and requirements of external accreditation bodies, its sponsors, staff, and students

• All staff and students must understand and be committed to their individual and collective responsibilities for quality

• To achieve these objectives, senior management will appraise the suitability of working practices and the training needs for existing and new employees. Through a process of continuous improvement in quality, the institution will endeavour to create an environment of mutual benefit for the staff, student, sponsors, and itself

To assist staff and students in implementing the Quality Policy, a set of guiding principles has been adopted and set out in the institution’s Quality Plan. Many governments, funding bodies, and other sponsors insist on formal quality requirements before contracts and grants are awarded.

This notebook provides extra guidance as to how the key elements of the institution’s Quality Plan can be implemented in practice and covers the following main themes.

• 1. Responsibilities

• 2. Health and safety

• 3. Training

• 4. Work practices (research work records, organisation of records, primary records in laboratory and other notebooks, secondary records, security and archiving, writing protocols – Standard Operating Procedures, handling of samples and materials)

• 5. Facilities and equipment (maintenance, correct use, logbooks)

• 6. Quality control (production of documents and records, quality control and performance checks, monitoring)

• 7. Further information

1.2.2 1. Responsibilities

In order to maintain a high standard of work, a team effort is required involving staff and students. All staff members have individual and collective responsibilities. They are responsible for the quality of their work and for personally following the guidelines of the Quality Plan. Senior staff members have overall responsibility for ensuring compliance with the Quality Plan within their area of activity. Some objectives of the Quality Plan will be more easily achieved if the efforts of individuals are coordinated (e.g. production of written protocols, instrument logbooks etc.). Ideally, selected individuals (Quality Representatives) within each area should be given this responsibility, with the full help and cooperation of their colleagues. These individuals will also be able to assess how effectively the principles of the Quality Plan are being met.

The institution has a Quality Manager who provides advice and assistance on quality-related matters but does not have direct responsibility for implementation of the Quality Plan other than areas of work covered by official laboratory accreditation according to ISO 9000.

1.2.3 2. Health and Safety

The institution has a formal Health and Safety Policy. The use of correct health and safety measures is a legal requirement and evidence of good working practice.. High standards of laboratory and workplace tidiness and cleanliness are essential. Before starting work, staff and students should ensure that the relevant health and safety information (e.g. risk assessments, safety data sheets etc.) and equipment (e.g. protective clothing, eye baths, medical kits etc.) are readily available and understood. For radioactive sources and substances, the correct official radiological protection measures should be followed. Dangerous organisms should only be handled according to official and legal conditions in accredited contained facilities. All individuals have a duty of care towards their colleagues.

1.2.4 3. Staff Training

All staff must have the appropriate qualifications, knowledge, and training for the type of work they undertake. Supervisors of students must ensure specific training is given to their students. Staff members are advised to keep their biodata up to date and include attendance at training sessions. Staff members have contracts of employment that should define their responsibilities, authority, and conditions of employment. A skill and technique-based Training Record for all staff should be retained centrally in order to comply with independent accreditation requirements.

1.2.5 4. Work Practices

Quality Assurance can be built into any work activity no matter how complex by sub-dividing the activity into manageable portions and by ensuring that at each stage the correct work practices are used at all times. In the context of research, this usually includes some or all of the following aspects.

1.2.5.1 Research and Work Records

Record keeping is the key to ensuring quality of work. Good record keeping gives confidence whereas poor records lead to chaos. The principles of data collection are (a) incomplete data leads to suspect results; (b) scientific conclusions must be supported by the data; (c) well-organised and cross-referenced data help accurate reporting of data; (d) incorrectly stored data may be lost or unreadable and are therefore worthless. “You cannot write up what you didn’t write down”.

For organisation of records, the records must be well cross-referenced so that all records relating to the work can be readily located. Therefore, records must be uniquely identified by means of a title, code or number, file name, date, named person etc. or a combination of these identifiers. Elements of these should be repeated in other related records so that the link between them is clear. The identity and location of work records should be noted, usually in a laboratory or equivalent notebook or entries in other logbooks, proformas, computer files, derived hardcopy etc.

Laboratory and other notebooks are the property of the institution and not the holder. Staff and students leaving the institution permanently must return their notebooks before departure. Such staff and students may be allowed to make copies for their personal use with the approval of their line managers or a senior member of the management. The notebooks serve as the primary record of research and other activities, detailing materials, methods, reagents, diagrams, conditions, references etc. Reference should also be made to other secondary records (photographs, traces, printouts etc.). It is bad practice to record experimental and observational information on unattached loose sheets, “post-its”, and loosely in files. Entries should be made in the notebook as the work is done, and dated and signed as appropriate. A third party should witness records if they are to be submitted for IP protection.

Secondary records include those on pre-printed proformas etc. and those created by computer and imaging systems. Where such items require approval, authentication, authorisation, checking etc., they should be signed and dated as necessary. Computer-based records fall into two general categories. The first are records created automatically by the data-capture device (e.g. GC, GC-MS. HPLC etc.) that are saved on raw data files or as direct output, and generally cannot be modified by the user. The second are user-generated records (e.g. word-processor files, data generated from raw data by subsequent manipulation) that can be modified. These may be retained electronically or as hard copy. Wherever possible, electronic records should indicate the date of creation or last modification, and the identity of the creator. Data-capture systems usually have this as a built-in feature. Hard copies should be signed and dated either electronically or by hand.

With regard to security and archival arrangements, experimental and observational data usually represent a great deal of hard work, time, and money, and should therefore be protected. Also, the data and other information may be confidential. It is therefore essential that work records are complete and stored securely. Accidents do occur in laboratories, instrument rooms, and workshops. Electronic records should be backed up regularly and duplicate copies made on appropriate storage media. Computers should be password protected with installed virus and malware scanning. Work records should be stored in lockable filing cabinets, cupboards, or desk drawers, with selected important hard and electronic copies stored away from laboratories, reagent storerooms, and workrooms. The identity of the records should be listed.

1.2.5.2 Written Protocols (Standard Operating Procedures)

In most laboratories and workrooms, there will be procedures that are carried out frequently, and it can be convenient to optimise the procedures and prepare a written outline or protocol. Reference can then be made to these written protocols or Standard Operating procedures (SOPs) in the notebooks without having to repeat full details every time. Written protocols are particularly useful in staff and student training. SOPs should always be prepared where possible, especially for routine activities of low variability. They can also be generalised, perhaps listing a number of alternative actions for different situations allowing for wider applicability. SOPs should be of a form that cannot be changed easily by unauthorised persons. A general outline of a suggested format for SOPs is outlined in section 19.4.2. For areas of work covered by formal accreditation, SOPs must be written to a standardised format, similar to the suggested format. Details of experimental procedures used for more variable, indeterminate, and exploratory activities should be clearly written in the notebook (primary research record) with appropriate reference to original literature, relevant SOPs, and all the experimental data. New SOPs can then be written when new experimental procedures have been tested and are in routine use.

1.2.5.3 Handling of Samples and Materials

Most work activities involve the handling and processing of samples, reagents, and other materials. It is important to ensure the integrity of such samples etc. and to avoid accidents, contamination, and loss. Therefore, all samples and experimental materials handled within the workplace should be clearly identified and labelled, and should be stored and handled correctly in the most appropriate storage conditions (freezers, containers, growth rooms, controlled atmosphere and temperature conditions etc.) Identification information should be firmly attached, and may have relevant work records attached. It is usually advantageous to keep a chronological or other record of reception and analysis/processing of samples etc. within the workplace. This is a specific requirement of formal quality systems such as ISO 9000. A logbook of sample reception can be created giving details of sample type and identity code, date received, process(es) to be carried out and date completed, and identity of the responsible person. Periodic checks should be carried out on the equipment used to confirm it operates properly (e.g. freezers, refrigerators, controlled environment rooms, fume cupboards, laminar air flow cabinets, centrifuges, scintillation counters etc.). Graphical records of the performance of refrigerators, freezers, growth rooms, glasshouses etc. will be needed for formal accreditation purposes.

1.2.6 5. Facilities and Equipment

The use of faulty equipment or its incorrect use can be dangerous as well as compromise the veracity of the work. All facilities and equipment should be suitable for the type of work and function correctly. Faulty equipment should be removed from the workplace, failing which it should be clearly labelled “Do Not Use”. Do not rely on word of mouth to inform colleagues. Equipment should be maintained depending on individual circumstances. Some items will be covered by service contracts with regular preventative maintenance. Other, often smaller, items may be used until they break down or fail to meet performance specifications. A written service and maintenance history should be created, detailing dates of serving and routine maintenance. See section on Equipment Logbooks.

Staff and students using equipment must be trained. Simplified instructions for use must be prepared in the form of a SOP. These are not intended to serve as a guide for untrained staff and students but to serve as an aide memoire for trained personnel and to assist in training. Generally, a checklist-type format is most useful.

Instrument logbooks must be used to provide a chronological record of use of typically larger items in a multi-user environment noting who, when, and for what duration the equipment was used. Equipment logbooks should be hardbound with numbered pages, usually hand-written but can consist of pre-printed pages bound in an appropriate manner; loose-leaf binders are not acceptable. Suggested content for an instrument logbook and details of how to produce custom-designed hardbound logbooks are given in the section Equipment Logbooks.

1.2.7 6. Quality Control

1.2.7.1 Production of Documentation and Records

All staff and students are responsible for making their own research and work records, and ensuring they are made in the correct way. Staff working in a specified area are responsible for preparation of any documentation used, including data-recording sheets, pre-printed forms, SOPs, Logbooks, checklists etc. Production and distribution of these documents should be controlled by the designated responsible person(s)m usually the author and/or Quality Representative(s). Other persons using the documentation can suggest alterations and amendments, but only the responsible persons can make changes and issue new copies. Manual alterations to documents are not allowed without prior approval to ensure several different copies of the same protocol are not in use at the same time. Superseded copies of documentation should be collected and disposed of.

Quality control and performance checks are essential. The performance of equipment should be routinely checked at regular intervals e.g. when used for measurement of physical properties (e.g. mass, temperature, radioactivity etc.) and when the accuracy of measurement is critical, or for separation, transformation, or identification of compounds and elements (e.g. GC, HPLC, GC-MS, NMR, EPR etc.). The appropriate standards, reference, or calibration materials should be used and limits for acceptable performance defined in SOPs. Records should be made of performance checks, including operator, date, and identity of the standards, reference, or calibration materials. Appropriate quality control measures should be taken during conduct of the work. For example (a) use of replication, sample blanks, standards etc.; (b) verification of correct content, format, and function of documentation and software; and (c) records of quality control measures should normally form part of the experimental results.

With respect to monitoring, if staff members follow the principles outlined herein, then their work should be of an acceptable high standard. In essence, reliance is placed on staff and their supervised students to judge how well their own work measures up to the principles. Nevertheless, some form of independent monitoring of conformance with the general principles of quality is beneficial, and is obligatory in accredited workplaces. An independent observer should carry out a brief assessment within each area, reporting back any problems, deficiencies in existing practices, possible improvements, and evidence of best practice. All findings should be followed up. From time to time, staff and students should get together to discuss quality-related matters, including the outcomes of monitoring. All the above can be done effectively on an informal basis. In areas covered by formal certification of accreditation, however, there is a formal programme of internal Quality Audits and Reviews. Audits, review meetings, production of reports, and identification of corrective and preventative actions occur at regular intervals. In addition, the certification body carries out an on-going programme of surveillance with regular on-site external audits (every 6 months for ISO 9000). Sponsors, grant-awarding bodies, and contracting bodies can also insist on their own quality audits.

1.2.8 7. Additional Information

Documentation (SOPs, Log pages etc.) used within areas covered by ISO 9000 certification is widely available as models. All of the matters covered here are described in the institution’s Quality Manual and available online from the institution’s website. The Quality Manual is based on the general requirements of international quality systems and simplified where appropriate.

1.3 C. Quality Plan

• The following lists a number of Quality Assurance measures that are applied in the laboratories and workplaces in the institution

• All staff and their supervised students are responsible for the quality of their own work activities. Senior staff, line managers, and supervisors are responsible for ensuring the overall quality of work in their own area of responsibility

• Quality representatives have the responsibility for coordinating the implementation of these measures

• All staff must be adequately trained for the work they do

• All staff and supervised must have an institutional notebook that should be used in the correct manner to record the conduct of their work

• Written protocols (Standard Operating Procedures; SOPs) for routine laboratory and workplace activities should be prepared. They should be in a form that cannot be easily changed by unauthorised persons

• All equipment must be functioning correctly when used, and should be used in the appropriate way

• Equipment must be appropriately maintained as determined by individual circumstances. Unserviceable or incorrectly functioning equipment must not be used

• Records of maintenance and servicing must be kept

• Staff and supervised students should be trained in the correct use of equipment

• Simplified instructions (SOPs) for operating the major items of equipment must be prepared

• Instrumentation logbooks must be used to record use of major items of equipment

• Equipment logbooks must be hardbound, have numbered pages, and can be entirely handwritten (legibly and indelibly) or they can consist of pre-printed pages bound in an appropriate manner

• Experimental and observational data etc. must be clearly recorded in the appropriate medium (e.g. official notebook, data-recording forms, and computerised data-recording systems)

• The data and information must be inter-related by use of appropriate means of identification

1.4 D. Standard Operating Procedures (SOPs)

1.4.1 Introduction

SOPs should be kept up to date and available where the procedure described is being applied. They should be as simple as possible. For long and complex work activity it may be best to sub-divide the work into a number of short SOPs. It is not normal practice to prepare SOPs for one-off or rarely used procedures. SOPs should be prepared by the individuals carrying out the procedure, using the language and style at the author’s discretion subject to the needs of the principle users and permission of the supervisor. Changes to SOPs must only be made by the responsible person. It is likely that similar documents will be prepared in several work areas in the institution so it should be possible to operate a standard format.

1.4.2 Suggested SOP Format

• Each SOP should have a tittle page with (a) a concise title and a SOP code (e.g. location of work area, subject identifier etc.). The Quality Representative in each area should maintain a master list of all SOPs and their codes. (b) A version number, indicating revisions. (c) Document file name. (d) Identifier of the author, approval of content by a knowledgeable colleague, and authorisation for use by the line manager or senior member of staff. The relevant person(s) should sign and date the title page. These functions can be combined if necessary. (e) Date of implementation subject to authorisation

• Section 1: Introduction. This covers purpose, scope, responsibilities, hazard warnings or safety precautions, and principle

• Section 2: Procedure. This covers inputs to process (reagents, materials, apparatus required); outputs from process (nature of results, products of process); control mechanism (quality-control measures); and procedure (list of actions performed). Some of these items may be omitted depending on the nature of the procedure

• Appendix if necessary

• It is recommended that each principle section should begin on a new page and section pages should be numbered as in the form e.g. Page 1.2 of 1 (i.e. page 2 of Section 1). This makes it easier to update parts of the SOP without reprinting the whole document. Each page should also indicate the current (most recent) version number, and the SOP title and code in order to prevent possible mix-up of pages from different SOPs

1.5 E. Equipment Logbooks

1.5.1 Primary Content of Logbooks

The type of information recorded will depend on the nature of the activity, but will typically include some or all of the following.

• Date of use and identity of user

• Identification (usually a numbered code) and details/description of any materials/samples processed

• Procedure employed, especially if there is multi-option capability

• Data files/directory (where the raw data are stored in computer files)

• Additional information for details not recorded elsewhere

1.5.2 Additional Information for Inclusion

• Instructions for the use of the logbook

• Location and identification of the equipment (manufacturer, type, model, serial number, date of manufacture)

• Service/maintenance arrangements and history

• Identities of the persons responsible for the equipment, and list of authorised users

• Project or contract numbers where relevant

The logbooks should be durable and hardbound. Channel-binding machines are suitable for hard-binding custom-designed pre-printed sheets with a provision for page numbering.