Further Guidance for UK Officially Recognised Efficacy Testing Facilities
Chemical control procedures
All chemicals should be uniquely identified (with a number and/or code), including unique identities for multiples of the same batch number.
The unique identification should be recorded on the booking in/out records, and on the chemical measuring records. This is to ensure that it is possible to tell which container was used in a particular trial or test.
Chemical expiry dates should be based on the expiry date as on the container or the date of manufacture (+ 2 years) where known (the supplier could be consulted for advice on an appropriate expiry date where none is given on the bottle). Nominal expiry dates based on the date of receipt (for example two years from receipt) should only be used in the absence of this information but must be clearly recorded this is the case.
Stocktaking procedures should be sufficient to ensure that where expired materials are held in the store they can be easily identified for removal or disposal and clearly marked as such, (for example with a permanent marker red cross) and preferably segregated from the main trials stock.
The Standard Operating Procedure (SOP) should specify the options for the disposal of chemical stock, and the criteria for choosing a particular disposal route should be briefly explained (such as return to sponsor/disposal via a licensed contractor/overspray on farm). We recommend including any proformas used to facilitate these systems in an appendix to the SOP on chemical control.
According to Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain, trials must be conducted and reported in accordance with European and Mediterranean Plant Protection Organization (EPPO) standard PP 1/181 and the design and analysis of trials must be in accordance with EPPO standard PP 1/152, and trials must be carried out in accordance with relevant specific EPPO standards, where available. Where details in the protocol, or SOP, are below the minimum specified in the relevant EPPO standard, these should be scientifically justified in the protocol or the relevant SOP (this might be a simple justification, or may require reference to specific scientific evidence).
It is important that all deviations below EPPO are scientifically justified and these deviations and justifications must be included in the final trials report. Compliance with guidelines and standards are some of the factors to be considered when reviewing SOPs and generating trials protocols. Note also that up to date copies of relevant EPPO standards should be available to all relevant staff.
The EPPO database on PP1 Standards provides further information.
If phases of efficacy testing are to be sub-contracted to a non-officially recognised organisation there must be written guidance for this (in the form of an SOP). This guidance needs to describe systems that will ensure that any efficacy related work is carried out to the minimum requirements of Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain. Where work is carried out under supervision and to an existing SOP, it would be sufficient to include a statement that all the equipment used was properly maintained/calibrated, and that appropriate records are kept and that the supervising facility has evidence that the relevant checks were conducted prior to the commencement of the trial. Where unsupervised work is to be carried out by a contractor, the guidance must fully describe the information required to demonstrate that the work is carried out to a written procedure by suitably qualified staff, and using appropriately maintained and calibrated equipment.
Training records must demonstrate that individual members of staff are suitably trained and experienced to carry out their designated functions. They should consist of three main components; a CV, records of formal internal and external training (plus copies of relevant certificates) and a record of on-the-job training.
The CV should reflect appropriate general training and experience, while the records of formal and on-the job training should reflect competence in more specific areas (such as disease assessments, and familiarity with relevant administrative procedures, eg chemical booking). The record of on-the-job training could be SOP or task based, and should consist of:
- a record of the date supervision in a particular task began
- the date that the member of staff was considered competent
- the identity of the supervisor
For experienced staff, competence in relevant tasks or SOPs could be based on 'assumed prior competencies', and can be recorded as such but there must be available appropriate evidence to support the use of this statement.
Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain requires that staff work to written operating procedures and protocols. It is therefore crucial that all assessment methodologies used in efficacy tests are fully described either in an SOP or in the trial protocol. The scope and detail of assessment methodologies must be sufficient to carry out the work, when used by suitably trained and experienced personnel.
In addition, Commission Regulation (EC) No 284/2013 as it applies in Northern Ireland and Great Britain states that crop phytotoxicity assessments are an essential component in all efficacy trials – including effectiveness and crop safety trials.
Protocol content and management
There must be a basic protocol for all efficacy trials and tests, in advance of the work being carried out. As a basic minimum, a trials/test protocol should contain:
- a descriptive title, the year and possibly a code number for the trial
- the objective of the trial/test
- a treatment list, including an untreated control, and the dose to be applied
- the target (for both pest and crop – if appropriate)
- details of trial replication, plot size, randomisation and application timing(s)
- details of the application volume and diluent (if appropriate)
- details of what information needs to be collected prior to, or at application
- an assessment schedule, including brief details of assessments to be made
- brief details of any data transformations and analyses to be undertaken
- brief details of any whole-trial maintenance treatments to be made
- a reference to all relevant general and specific EPPO standards used
- possibly, any justifications for deviations from EPPO standards
- the protocol needs to be signed-off as "finalised", prior to the commencement of any work
- a version number for the trial/test protocol could be included, so that subsequent changes to the protocol can be tracked
Protocol amendments need to be recorded on or with the protocol (with a brief justification for the amendment) signed and dated.
Adding an extra treatment to the treatment list after it has been finalised and issued, but prior to work commencing (this may have been suggested by the marketing department of the organisation). This amendment can be recorded in one of two ways;
- by writing a comment directly onto the existing protocol
- by generating a new protocol with the additional treatment
Either way, the procedure would need to be authorised (signed and dated) by an appropriate member of staff.
There must be a formalised procedure (SOP) for issuing protocol amendments.
Protocol deviations need to be recorded in the raw data (again with a brief explanation for the deviation) signed and dated.
The disease target is present at levels that require treatment at growth stage BBCH 31 (earlier than the planned application timing). A decision is made to apply the treatments immediately, to enable the trial to remain within the criteria that it should be sprayed at the first signs of disease. This deviation must be recorded in the raw data, along with the explanation, signed and dated by the person who carried out the deviation.
There must be a formalised procedure (SOP) for undertaking and recording protocol deviations.
Standard Operating Procedure (SOP) content and control
A standard operating procedure should (when used in conjunction with the trial/test protocol or other referenced information) contain all the information necessary to perform that task. SOPs should cover the full scope of the work carried out by the facility or organisation. This should include any procedure regularly carried out relating to the generation or retention of efficacy data or associated records. The level of detail in an SOP should reflect the level of training and competence of the staff using that SOP.
Example of required SOPs (for standard type efficacy trials work)
- writing, reviewing, updating, distributing and controlling SOPs
- trial/test protocol content and management (including procedures for recording amendments & deviations)
- collection, handling and storage/archiving of raw test data (including procedures for collecting raw data and identification of the assessor, responsibility for the archive, the location of data, procedures for booking in and temporary removal of data from the archive and possibly a definition of raw data - ie data, calibration records, maintenance records, chemical store records, SOPs)
- preparation of test substances/materials for application/treatment purposes
- use, maintenance and calibration of test equipment (eg application equipment, balances, seed drills, combine harvesters). It is advisable to write separate SOPs for each type of equipment
- selection criteria for choosing trial/test sites, including trial layout and site identification
- collection of environmental and site specific data, relating to the trial/test site
- trial/test assessment methodologies, plus procedures for recording deviations from those methods and any additional operations to be observed. These should include reference to any specific EPPO standards to be followed and/or any other expert keys/guidelines to be used
- chemical control procedures (including unique identification of test substances & standards, booking in/out procedures, stock-taking and disposal procedures)
- the taking and archiving of digital photographs used to support efficacy trials
There must be a nominated individual responsible for the control and distribution of all SOPs including version control. There must also be a nominated individual responsible for retaining and archiving the 'master copy' of all SOPs, including all current, superseded and retired SOPs. There needs to be a formalised distribution system for SOPs, along with a procedure for ensuring that superseded and retired SOPs are taken out of the system. SOPs must be reviewed regularly by appropriate staff. There should be a formalised system for amending SOPs between reviews. There must also be a system for 'activating' SOPs by means of an 'authorised signatory' and 'activation date' on each SOP.
Example (where re-issuing the SOP under a new version number is unnecessary until scheduled review):
A typographical error has been spotted in SOP 04 'Assessment of Green Leaf Area'. This is not serious, so an e-mail is sent to all holders of SOP 04 to amend the SOP by hand, with the correct wording. This is then initialled & dated by the SOP holder, plus a note 'as required by e-mail of 02/07/12 from TF'.
Guidance on writing Standard Operating Procedures (SOPs)
All SOPs should be written in a clear and concise manner. The procedure should be described in simple, easy to understand and unambiguous text. The use of flow-charts may assist in highlighting the sequence in which actions take place. Each SOP should address the following topics for the defined activity;
- WHAT activity is described
- WHO will conduct the activity
- HOW the activity is conducted
- WHERE the activity is conducted
- WHY the activity is conducted
- WHEN the activity is conducted
Not all of these categories may be applicable to all SOP"s. However, it is essential that every SOP addresses WHAT, WHO and HOW.
SOPs should contain
- a title
- the objective
- a unique SOP number
- a version number
- page numbers on every page (eg page 3 of 6)
- any appendices/attachments relating to the SOP
- a copy number
- an effective date
- a 'signed-off' date plus signature(s)
- a distribution list
- a review date
- if required, a list of references to other documentation/related procedures
Each SOP should contain the following sections
- the purpose
- the scope
- an outline of the procedures
- any references cited
- the specific procedure
SOPs should be written in a style that, though providing a clear unambiguous description of the activity, still allows (where necessary), a degree of flexibility. This will be most relevant for SOPs describing the use of equipment. Where possible, SOPs should describe the operation of a generic equipment type, and not be restricted to a description of how to operate a specific model or make of such equipment.
Where the procedure indicates options for the conduct of a particular activity, the author must provide clear unambiguous guidance on the selection criteria the operator should use in making a decision.
SOPs should act as management control tools, to ensure all activities are conducted in a consistent manner which is acceptable with the aims of that facility/organisation and any compliance programmes they may relate to. It is management responsibility to 'sign-off' SOPs.
SOPs should be prepared, where possible, by a person who will conduct the activity, or who is familiar with it. Regular review of SOPs should be carried out by the management of the facility or organisation, to ensure that documented procedures continue to reflect current operational practice. Revision of SOPs should be structured, although revisions may be identified through a number of routes; management review, audit, or operational activities (eg changes to practice). The responsibility for revisions to SOPs rests with the management of the facility/organisation.