ACP Fish II - Welcome - Final Technical Reportacpfish2-eu.org/uploads/projects/id670/Technical Report... · 2014. 1. 30. · Page 4 of 80 Executive summary In 2010 ACP Fish II in

"Strengthening Fisheries Management in

ACP Countries"

Project Funded by the European Union.

“This publication has been produced with the assistance of the European Union. The contents of this publication are the sole responsibility of ”name of the author” and can in no way be taken to reflect the views of the European Union.”

“The content of this document does not necessarily reflect the views of the concerned governments.”

Final Technical Report

Workshops on International Trade Issues and Standards for Solomon Islands

Project ref. N° PAC-4.1-B18b

Region: Pacific Country: Solomon Islands

Date: September 2013

A project implemented by: Richard Chivers

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Table of contents

ABBREVIATIONS AND ACRONYMS ........................................................................................... 3

EXECUTIVE SUMMARY ............................................................................................................... 4

1. BACKGROUND ....................................................................................................................... 5

2. APPROACH TO THE ASSIGNMENT ................................................................................... 6

3. COMMENTS ON TERMS OF REFERENCES ...................................................................... 6

4. ORGANISATION AND METHODOLOGY ........................................................................... 7

5. CONCLUSIONS AND RECOMMENDATIONS .................................................................. 11

ANNEX 1 – INCEPTION REPORT............................................................................................... 14

ANNEX 2 – TRAINING MATERIALS ......................................................................................... 15

ANNEX 3 – AUDIT PPT PRESENTATION.................................................................................. 56

ANNEX 4 – REG 882 2004 ............................................................................................................. 72

ANNEX 5 – DOCUMENTS CONSULTED.................................................................................... 74

ANNEX 6 – WORKSHOPS ............................................................................................................ 76

ANNEX 7 – ITINERARY, INSTITUTIONS AND INDIVIDUALS CONSULTED ...................... 79

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Abbreviations and Acronyms CA Competent Authority

FFA Forum Fisheries Agency

FVO Food and Veterinary Office (of DG SANCO)

HACCP Hazard analysis critical control point

NCP National Control Plan

NFD National Fisheries Development

MFMR Ministry of Fisheries and Marine Resources

PHAMA Pacific Horticultural and Agricultural Market Access

PHV Pilchard Herpesvirus

SPC Secretariat of the Pacific Community

SSI Southern Seas Investments Ltd

ToR Terms of Reference

TT Technical Team

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Executive summary In 2010 ACP Fish II in consultation with the Solomon Islands Government and regional fisheries representative bodies drew up plans for a project that would adapt the Solomon Islands fishery products legislation to the regional markets and that of the EU. As it was not possible to launch the project that year some of the work described in the original Terms of Reference (ToR) was completed by another donor. It was necessary for the specialist to consult with the stakeholders in Honiara to establish their current needs. Adapted ToR were devised by a Technical Team (TT) and subsequently approved by the Co-ordination Unit and DEVCO. These alterations developed and complemented the work carried out by the other donor organisation. The needs were identified as:

a) Training in hazard analysis and critical control point (HACCP) for industry, b) Training in auditing and EU legislation for the Competent Authority (CA), c) Organising a meeting between the Competent Authority (CA) and the Ministry of

Fisheries and Marine Resources (MFMR) at which the respective inspectors would share their experience of official controls in the fishing industry

d) Carrying out a risk assessment on the hazard to biodiversity by the import of baitfish Training for industry was carried out in three events. The first was in Honiara where up to 12 personnel from Southern Seas Investment received training for two days in HACCP. The second and third were held in the Western Province at Noro, where the Soltuna canning factory and its supply arm National Fisheries Development (NFD) was based. The training was well received and all participants remarked on the usefulness of the program. Approximately 40 people in total were trained in the three events. Training in auditing skills for the CA was carried out over two days in Honiara and one day in Noro (five staff total). The CA already had a degree of training, given seven years previously, so refresher training was provided. Internal audit was regarded as an important aspect of the CA’s function, especially as the DG SANCO’s Food and Veterinary Office (FVO) were due to visit in 2014. Training was focussed on developing auditable procedures and an audit schedule. Further work with the CA involved practical sessions to develop a knowledge of the Eur-Lex website and the process for updating computer copies of the EU legislation. The CA’s fish processing and vessel certification function may move to the MFMR to combine the fisheries and food safety/export aspect of the Government’s official controls in one department. The two departments considered that it would be beneficial to meet and discuss their respective roles. A meeting was organised but had to be called off on the morning it was due to take place due to an internal emergency at the MFMR. The Forum Fisheries Agency (FFA) understood that there may be a hazard to the health of the Solomon Islands stocks of small pelagic fish if disease were introduced to the region by baitfish imported for the longline industry. They requested that the specialist researched the subject and carried out a brief risk assessment of the hazards posed.

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The research concluded that there was a hazard of low significance for baitfish used on the high seas and potentially a greater risk to both small pelagics and the environment in inshore waters. Recommendations for protocols to control the risks were made.

1. Background The Solomon Islands lie in the Western Central Pacific where it enjoys access to large tuna stocks. The state has a Fishery Partnership Agreement with the EU and also licenses fishing rights to Chinese and Thai purse seiners. The country has one of the lowest per capita incomes in the Pacific and its population’s well-being has improved little since independence in 1978. Fishing either artisanal or subsistence (primarily in the distant islands) and farming are carried out by 75% of the population. The state is heavily dependent on donor aid, principally from Australia, New Zealand, the EU, Japan and China. Private Industry The Trimarine owned Soltuna Ltd cannery at Noro was the country’s largest single employer and sourced raw material from longline, pole and line and purse seine vessels that were contracted to the sister company National Fisheries Development Ltd (NFD). Between them they represented the main national tuna interests. Most of its canned product was sold to local and regional markets but it exports frozen cooked loins to the EU (Italy). Recently (early 2013) Southern Seas Investments (SSI) opened a small factory that airfreighted chilled tuna to Japan, the USA and Australia. The industry representatives on the TT (Primo Ugulu and Nollen Lennie – refer to Annex 7) considered that a knowledge of HACCP would benefit the industry and accordingly arrangements were made for training to be provided in both Honiara (SSI) and Noro (Soltuna and NFD). CA The CA, which forms a section within the Department of Environmental Health, had responsibility for all food operations in the islands; fish processing and inspection of vessels formed only part of the work they carried out. The staff was already proficient in HACCP from training received in 2006-7 and so did not feel it was necessary for them to have further inputs. They also had some audit training but considered that they would benefit from top-up training, especially as the FVO are due to visit in 2014 and the previous visit, although successfully negotiated highlighted certain areas (e.g. laboratory functions, export certification standards) where improvement was needed. It was felt that a full internal audit program would be most beneficial in preparation for the FVO inspection.

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CA/MFMR Inspectors’ Meeting There are plans for the CA function to move to the MFMR, though nothing was in hand at the time. Bearing this in mind the two departments felt that they would benefit from a meeting at which both sets of inspection staff could explain how their jobs worked. Accordingly the consultant was asked to facilitate the meeting. Biodiversity hazard The Forum Fisheries Agency representation on the TT voiced fears that the Solomon Island stocks of small pelagic fish could be damaged if disease spread through the population. Concerns were raised because there were suggestions that a mass fish kill had occurred in Australian waters and that the deaths had been attributed to the import of diseased sardines from South Africa destined for the offshore tuna farms. Little else was know about the issue and the consultant was asked to investigate, carry out a risk assessment and make recommendations for actions that could be taken to diminish the opportunity for disease to be introduced from imported baitfish used by longliners.

2. Approach to the assignment The assignment was carried out by one Key Expert who liaised with the TT and the CA and industry representatives to ensure that all parties had been heard and that their interests would be satisfied at the end of the project. The bulk of the work was preparing and delivering three training events for industry and two for the CA. The approach taken by the consultant was as practical as possible, avoiding unnecessary theory and ‘classroom’ learning, preferring instead to be guided by the principles ‘I hear, I forget’, ‘I see, I remember’, ‘I do I understand’. The emphasis throughout the training events was on doing, and although PowerPoint was used for illustration and to put a point across in a pictorial manner, most of the work was done by teams or individuals with pen and paper or computer as suited the type of training being carried out. Research of biodiversity hazards was by internet. How this was carried out is explained in greater detail in the body of the report. A courtesy call was made on the EU Delegation in Honiara to explain the background to the intervention.

3. Comments on Terms of References Given that the original terms of reference had largely been undertaken by the time this mission was launched, a meeting was held as soon as the specialist arrived in Honiara. The attendees at the meeting represented industry, the government and the advisory bodies Pacific Horticultural and Agricultural Market Access (PHAMA) and the Forum Fisheries Agency (FFA). With the stakeholders well represented these people became the TT.

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New aims for the mission were agreed and over the first week of the mission considerable discussion took place to agree new ToR, which sued the original ToR as a platform from which to launch the desired training events. Refer to Annex 1, Revised Inception Report and Revised Terms of Reference

4. Organisation and Methodology 4a) Delivery of Terms of Reference (table as below)

Terms of reference Delivery 1 Briefing by the ACP Fish II

programme and Solomon Islands Government Departments

A meeting took place on the first day on site (19/08/2013) at the Fisheries Department HQ, attended by the ACP Fish II, CA, the MFMR, FFA and industry representatives.

2 Establishment of a Technical Team

Done at the meeting mentioned above

3 Work closely with the TT and stakeholders

The TT and stakeholders were consulted throughout the planning and review of the training processes

4 Work with the TT and stakeholders to adapt materials as necessary

The stakeholders were consulted on their existing training and the materials used by the specialist were adapted to the appropriate level

5 Provide training in auditing skills to CA

The CA’s existing training was reviewed and used as the benchmark for further training, which was redirected towards developing an internal audit program

6 Provide training for approximately 40 industry staff on HACCP

Three training events were held at which more than 40 people in total were trained in HACCP at levels from introductory to intermediate

7 Provide the CA with training in the use of the Eur-lex website and EU regulations

Training was provided for the CA in the use of the web site, with examples and work plans. Additionally legislation was updated.

8 Facilitate a meeting between the CA and the MFMR

The meeting to be held on 10/09/2013 was prepared for during the previous days but in the event could not take place, as the MFMR staff was called away by an emergency on the morning of the meeting.

9 Carry out a risk assessment of the microbiological hazards of imported baitfish

The assessment was undertaken, though the time needed was much more than the projected 2 days. 4-5 days were taken spread over a period of about 1 month.

10 Hold a final meeting with the TT to collate views

The meeting was held, though the numbers were reduced by absences due to holidays and the impending tuna conference

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4b) Conduct and details of the assignment including visibility activities.

A press release was arranged and presented to the ACP Regional Manager during the first week of the mission. Methodology Industry HACCP Training Three events were arranged by the consultant, each of two days duration. At each one a PowerPoint presentation (Annex 2) was used, although most of the learning was carried out as a practical workshop with the participants working in pairs or groups of up to four individuals. The groups were asked to go through the whole process of carrying out a hazard analysis study using work sheets that each one had to fill in (Annex 2). By the end of the two days, all delegates had completed a hazard analysis, had been provided with the PowerPoint in hand-out form and had received a copy of the reusable work book devised by the consultant ‘Do this, Tick it!’ The book was 24 pages long (see Annex 2) and was aimed at the more advanced HACCP staff and those who would eventually be responsible for their company’s HACCP system. A copy of ‘Do this Tick it!’ was also left with the CA. All participants were issued with ACP Certificates of Attendance. Soltuna and NFD, which had the most comprehensive HACCP systems, requested that the consultant reviews the content of the documents. This was carried out at separate meetings with the QC Manager and the Chilled and Frozen Manager of NFD. No changes were needed in Soltuna’s case other than the removal of the CCP labelling ‘Contains fish’ on frozen cooked tuna loins bound for the canning market in Europe. As a non-customer facing product it was not necessary to warn of the allergens at this stage of production. NFD the local fishing arm of Trimarine and a sister company to Soltuna, ran a full HACCP system. They were informed that for EU purposes this was not a legal requirement unless there was a processing step on board the vessel and definitions and proofs of Article 5 of Regulation 852/2004 were provided to avoid confusion. The point was made however that the EU did expect that good fishing practice would be observed and that included the food safety elements of histamine control.

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CA Training Two days were spent with the CA in Honiara (three members of staff) and 1 day in Noro (two staff). The processes involved in auditing were reviewed as refresher training using a PowerPoint presentation. Then followed the need for the CA to fulfil its own mandate - that it would undertake internal audits. To achieve this it was first necessary to review the two main documents that dictated the CA’s activities in the fishing industry, the National Control Plan (NCP) and the Industry Standards and start the long process of converting the aims and strategies they contained into auditable, documented procedures that described the day-to-day activities needed to complete the processes. One of the elements of the NCP was used as an example and the staff were asked to present it as a procedure. The consultant also left them with a copy of a completed procedure that they could use as a template – a procedure for Internal Audit (Annex 3). Other documents that were both used and left in blank and completed form were the Audit Summary Sheet, the Audit Questionnaire and the Corrective Actions Record (the latter two were contained within the Audit Procedure – Annex 3) Training in the use of the Eur-Lex website was undertaken in practical fashion, using the staff’s own computers to and giving examples of relevant regulations that the staff had to locate and download. A worksheet was used in Honiara for the staff to practice with and the leader of the CA was provided with a list culled from EU Regulation 882/2004 (Annex 4) of all the subjects for training recommended for bodies carrying out official controls. The latter was suggested as a reference document that the leader could use for targeting future training. Biodiversity Hazards Research was all internet based, suing Google, Google Scholar, the consultant’s own knowledge and experience and the consultant’s own contacts. Annex 5 relates These definitions were observed: Hazard: A biological condition with the potential to cause an adverse effect Risk: The likelihood that a hazard will occur. Significance of the hazard: Assessment of severity of the hazard should it occur and its likelihood of occurrence. Some difficulty was experienced at first in locating the correct sources, as there was scant information available to the FFA. The only information they had was that there had been at one time a fish kill involving small pelagic fish in Australian waters, and that the deaths

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had been attributed to the importation of South African sardines to be used as fish feed in the bluefin tuna fish farming industry. Numerous lines of enquiry were followed including marine invasive species, the potential for disease and parasite survival in frozen product and international fisheries research bodies until at last a private contact identified the issue that had troubled Australia. In short, there were in 1995 and 1998 two massive fish mortalities in the pilchard stocks of south and west Australia, certainly the largest ever recorded in the world; 70% of the biomass was lost in the second epizootic. Although never proven imported sardines/pilchards from the USA, Chile or China used as baitfish in the tuna offshore farms, were held to blame for introducing the pilchard herpesvirus (PHV). One of the researchers in 2002 (Gaughan) pointed out that Denmark had unilaterally amongst EU members banned the use of untreated (i.e. not processed into pelleted feed) fish for feed in aquaculture. He went on to point out that there were considerable dangers, not only of bringing disease to target fish e.g. the pilchard industry but also to the ecosystem, which may become unbalanced as fish were lost but not noticed until other species felt the impact. In the event the Australian pilchard stocks recovered in a period of less than 10 years and are now immune to the disease. The danger for the Solomons Islands was regarded as a hazard of low significance to the oceanic stocks of small pelagics as baitfish used in the longline industry presented a much lower concentration of diseased animals compared with the tuna growing industry. However a danger did exist for the stocks of juvenile pelagics caught by pole and line fishermen for live bait and also for their importance in the ecosystem balance. The hazard was the dumping of waste baitfish or of washing out baitfish containers in inshore or harbour waters, where the virus could spread amongst susceptible populations. The waters could be protected by ensuring that washing and dumping were carried out in the open ocean. Wrap-up Meeting with the TT The consultant organised a meeting of the TT to report the activities carried out and to collate the team’s views on the successes or otherwise of the project (Annex 6). Only two members of the team were available, Judith Reynolds and Dale Hamilton. Each was satisfied with the progress made. Dale Hamilton suggested further food safety and HACCP training, to follow a nationally recognized standard would benefit the stakeholders. He also felt that there would be a good argument for research into the potential for PHV to affect stocks of pilchards and other species of valuable small pelagics in Solomon Islands waters, perhaps carried out by the Secretariat of the Pacific Communities (SPC).

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5. Conclusions and recommendations

Private Industry Conclusions

1. HACCP training was a legal essential for each of the factories (Soltuna and SSI) under the terms of the Pure Foods (Fishery Products) Regulations 2005, for companies involved in export. A proactive approach had been taken by each company, which aimed at ensuring that their staff had a basic understanding to the purpose of AHCCP and the terminology. By doing so they strengthened their staff as a team with common understanding and recognition of the importance of each other’s work.

2. As a fishing company, NDF did not need to carry out a full HACCP study to satisfy EU requirements, only to carry out good industry practise. However, they chose to put their staff on two days training in the same manner that Soltuna did and achieved a unity amongst them by gaining an awareness of the main terms of HACCP and their importance to the company policies and ethos. And in doing so, they satisfied the EU demand for good fishing practise - knowledge of fish products’ safety is an essential element of safe handling practice.

Private Industry Recommendations

1. The industry would benefit from a series of structured training events in HACCP at one of three recognised levels of performance. In the UK these would be at National Curriculum Levels 2 (Introductory), 3 (Intermediate) and 4 (Advanced).

2. Industry leaders could propose staff for training, breaking their needs down according to their work requirement.

CA Conclusions

1. The CA were well trained in third party auditing but at the time did not carry out audit practise in the factories, rather they carried out a series of repetitive inspections that kept returning the same non-compliances.

2. They also did not have a program of internal audit for their own functions. The consultant deemed it essential that they should do so to ensure that their own systems were effective and to have evidence to demonstrate their capacity to undertake official controls to the FVO inspectors.

3. Achieving this is more difficult when CA activities are encapsulated as targets in the NCP and Industry Standards. It would be easier if they were translated into auditable procedures that assigned, purpose, scope, process and documentation to the aims. At this stage it may be too late to achieve a full internal audit before the FVO inspection but starting it will reveal many short-comings, as would be expected in a new system.

4. The CA held records of EU legislation in hard copy only. These became cumbersome and out-dated very quickly. After training in the use of the Eur-lex website the CA would be able to check frequently for changes to the legislation and update their computer records, without the need to take hard copies.

5. There are a number of areas for training outlined in EU Regulation 882/2004 all of which were fully covered for each member of staff. The leader of the CA needed to be aware of limitations in these areas and make preparation for training whenever possible.

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CA Recommendations

1. The consultant recommended that the CA focus on those activities crucial to food safety when auditing the factories and pursue a series of audits, rather than inspections, that would reveal the root cause of any non-compliances against the NCP or Industry Standards.

2. The consultant recommended that the CA pursued a rigorous agenda of internal audits based on an annual schedule. The process should start with immediate effect to gain most benefit prior to the FVO visit and encompass all their fish products and vessel certification activities.

3. To achieve 2, above, the CA would need to interpret the NCP and the application of controls over the Industry Standards as documented procedures. It is recommended that the CA leader delegates each member of staff with the task of drawing up procedures based on the template provided by the consultant, then holds a team meeting to compare the results, shake them down and pursue the same activity but with an improved and common standard.

4. That the CA leader assigns a member of staff to the task of checking all relevant legislation twice per year. A schedule would help to ensure completion of the full record.

5. Using the list provided (see Annex …) the leader of the CA to review each member of staff’s training record (including her own) and create a matrix for training needs (including refresher training). These are to be presented as an agenda item to support requests for future donor inputs.

CA/MFMR meeting Conclusions

1. As it turned out the timing was not right to hold this meeting, the MFMR inspectors were unexpectedly called away to make inspections of vessels and visit Fiji; in addition there was a regional tuna conference to prepare for. The CA leader had prepared an excellent presentation on her department’s activities that could be used at another time.

CA/MFMR meeting Recommendations

1. That the meeting be re-arranged for a quieter time of the year.

Biodiversity Hazard Assessment Conclusions 1. After the mission was completed but before the Final Report was written one crucial

contact (one of the lead scientific investigators from Australia) emailed the consultant with this view ‘there are theories on where the virus in Australian pilchards originated from, but it was never proven due to a lack of availability of suitable samples’. The source of the pilchard herpesvirus was not further pursued but the evidence from the research that was reviewed by the consultant pointed towards the importation of an introduced pathogen.

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2. If, as is suspected the virus was brought in by imported pilchards from the USA, Chile or China, the risk assessment indicates that there would be less chance of an epidemic occurring in Solomon Islands open ocean waters due to the small quantities of baitfish spread over a wide area when used as longline bait. Inshore, where live bait are caught there may be a greater risk to juvenile pilchard stocks from waste disposal from longline vessels.

Biodiversity Hazard Assessment Recommendations

1. That for the safety of the inshore juvenile pilchard stock used for live bait (and anchovies in case the disease can affect them) protocols should be put in place that would minimise the likelihood of infection for example, no dumping of waste pilchard material or washing out of bait containers in harbour.

2. That research be commissioned to establish if PHV can infect other species. SPC were suggested as the body with the capacity to organise such research.

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Annex 1 – Inception Report Inception Report including Revised Terms of Reference (see separate file)

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Annex 2 – Training Materials Industry Training Materials:

1. PowerPoint Presentations on Auditing and Internal Auditing 2. Do This Tick It! Work Book for HACCP Development 3. HACCP Work Sheets

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The DO THIS, TICK IT! Checklist for building HACCP Systems

Richard Chivers www.fishonline.co.uk

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References This guidebook was constructed from material found in Campden BRI Guideline 42, HACCP: A practical guide With additional information from: CIEH: An Introduction to HACCP for Food Manufacturing by Alan Brereton ILSI: A Simple Guide to Understanding and Applying the HACCP Concept How to use this guide The guide is formulated to provide a simple and clear step-by-step approach to preparing a full HACCP plan. All you need to do is check the Stage and go one at a time, then the ‘Do This’ column, when you have the documentation to prove you have ‘Done This’ you can photocopy the page and tick the box. The table headed ‘Details’ includes various forms of expanded information that I think helps to develop the understanding of the ‘Do This’ column. Sometimes it includes examples, sometimes definitions. Each page is self-explanatory however, the need to read around the subject cannot be overstated and the user is advised to refer to the references above for a more complete understanding of HACCP. Good Luck and enjoy your PIGS (sourced at Campden) and CAN-DOs! (source Richard Chivers) If you need further explanation, please contact me on [email protected] or through my web site www.fishonline.co.uk

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Campden BRI 14 Stages to HACCP

Stage 1 Obtain senior management commitment

Stage 2 Define the terms of reference/scope of the study

Stage 3 Select the team

Stage 4 Describe the product and process

Stage 5 Identify the intended use of the product

Stage 6 Construct a process flow diagram

Stage 7 On-site confirmation of the flow diagram

Stage 8 List all potential hazards associated with each process step, conduct a hazard analysis and determine the measures to control the identified hazards

Stage 9 Determine the CCPs

Stage 10 Establish critical limits for the control measures at each CCP

Stage 11 Establish a monitoring system for each CCP

Stage 12 Establish a corrective action plan for each CCP

Stage 13 Perform validation, verification and review activities

Stage 14 Establish documentation and record keeping

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STAGE 01

Do this Done it?

Tick it! Detail

MANAGEMENT COMMITMENT

Create a Policy Statement stating upper management commitment to support HACCP

Benefits of Management commitment: Bring management skills to the team Authorise changes Management can prioritise actions Control the timetable Authorise purchase equipment Authorise time needed to implement HACCP plan Authorise training to support HACCP

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STAGE 02

Do this Done it?

Tick it! Detail

SCOPE AND TERMS OF

REFERENCE

Scope: Define the start and end of a process or of ownership of product

1. Four categories of hazard are: i. Microbiological ii. Physical/foreign body iii. Chemical iv. Allergenic

2. References will contain e.g. a. Standards applied b. Legislation c. Science

Terms of Reference: State categories of hazard considered

List the PRPs

List references used

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STAGE 03

Do this Done it?

Tick it! Detail

FORM TEAM

Select team leader

1. Team Leader must have knowledge of HACCP and experience with product.

2. Good characteristics of team members: a. Knowledge of the process (e.g. supervisors) b. Positive attitude c. Problem solving

3. Have a secretary or other minute taker – all meetings must be minuted

Define roles in the team

Minute taker

Example of a HACCP Team List

Role Name Function Experience/Qualification Leader Frank Osbourne Head QA 11yrs canning industry

BSc Microbiology Production Specialist Julian Du Supervisor 5yrs production canned products Product Specialist Maggie Consort Sales Manager 20yrs international canned fish sales

Certificate in Business Management

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STAGE 04

Do this Done it?

Tick it! Detail

DESCRIBE PRODUCT

Prepare a tabulated product description

‘Know’ your product – what makes it safe? Understand the factors that could make it unsafe Fill in descriptions of characteristics. Here are some suggestions:

1. Title: the end product 2. Raw Material 3. Storage conditions for raw material 4. Product composition: Recipe/Raw materials 5. Processing: Heat treatment regime/Other

preservation techniques 6. Packaging 7. Storage conditions 8. Shelf life: Use By or Best Before 9. Consumer Instructions 10. Micro biological data: Micro flora maxima

specified 11. Physical/Chemical Parameters: Aw; Ph 12. Distribution

Example of Product Description (part) Product type Tuna in 100g cans with vegetable oil Ingredients Tuna (78%), Sunflower oil (19%), Salt (3%) Raw Material Tuna: (list Latin names of species used)

Sunflower oil Vacuum dried sea salt

Processing Low risk: butchering tuna carcasses etc. Cooking: retort (to standard processing time)

Packaging Bottles, vacuum packs, cans (supply specification as appropriate

Shelf life Best before 3 years from production date Consumer Instructions

Keep refrigerated after opening and eat within 3 days

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STAGE 05

Do this Done it?

Tick it! Detail

IDENTIFY INTENDED USE

Understand your consumer: a) their wants, b) the way they will use the

product and c) the way in which THEY may

abuse the product

Ask yourself: 1. How may the product become unsafe 2. How may it become unsafe if used by vulnerable

groups 3. Does it require allergen labelling

Identify vulnerable groups e.g. infants, infirm/ill, elderly

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STAGE 06

Do this Done it?

Tick it! Detail

FLOW DIAGRAM

Prepare flow diagram

Key elements: 1. Know your process 2. Identify all relevant steps including addition of

services e.g. water 3. Update when process changes 4. Gather supporting information on all steps

Supporting information collected

Select supporting information as needed: 1. Specifications

a. Ingredients b. Additives c. Packaging d. Finished Product

2. Floor plans a. Layout b. Ancillary areas c. Water/Steam

3. Time/Temperature History a. + potential delays

4. Flow conditions for liquids and solids

5. Equipment materials

6. Building construction 7. Equipment design incl. voids 8. Cleaning and disinfection Personnel

routes 9. Potential for x-contamination

a. Raw/RTE 10. Route taken by waste 11. Segregation of high and low risk

areas 12. Personal hygiene practices 13. Storage and distribution 14. Consumer instructions

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STAGE 07

Do this Done it?

Tick it! Detail

CONFIRM FLOW DIAGRAM

Walked the line?

Ensure the plan is kept up to date

Team Leader signed and dated verified flow diagram

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STAGE 08a Principle 1

Do this Done it?

Tick it! Detail

HAZARD

ANALYSIS: LIST RELEVANT

HAZARDS

Do the hazard analysis records contain reference to the use of the Terms of Reference

List only those hazards that you may REASONABLY expect to be associated with the food e.g. present on raw material or introduced at a processing step

Do the hazard analysis records contain reference to the use of the flow diagram

Do the hazard analysis records contain reference to the four categories of hazard

Do the hazard analysis records contain reference to the consideration of:

a. Delays b. Temporary storage c. Customer abuse

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STAGE 08b PRINCIPLE 1

Do this Done it?

Tick it! Detail

HAZARD

ANALYSIS: ANALYSE THE HAZARDS AND

CONTROLS

1. Define likelihood of hazard occurring – see matrix

Let your PIGS loose at this Stage! And consider hazards in their terms:

Presence

Introduction (Contamination)

Growth

Survival You can use a matrix to help assess the SIGNIFICANCE of the hazard:

Like

lihoo

d 3 3 6 9 2 2 4 6 1 1 2 3 1 2 3

Severity

Scores of 3 and above are significant hazards that require specific controls. Below 3 are controlled by PRPs, where failure will not cause an immediate food safety hazard.

2. Define the severity of the hazard – see matrix

3. Define the numbers exposed

4. Define vulnerable groups likely to be exposed

5. Assess survival of the hazard in the product and growth if microbiological

6. Assess toxin production and survival

7. Assess opportunities for contamination (introduction)

8. State sources of hazard

9. Did you consider all categories of hazard?

Depends on experience and judgement. Do

you have these in the Team

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STAGE 08c Principle 1

Do this Done it?

Tick it! Detail

HAZARD

ANALYSIS: CONTROL

MEASURES

Controls for all hazards and causes listed

1. In the controls column include the specific control for the hazard (does not have to be at that step e.g. At butchering step: microbiological contamination in raw fish destroyed at cooking step).

2. Also include the PRPs relevant at this point.

Procedures for each control exist

Specifications for each control exist e.g. time temperature regime

Here is an example:

Process Step No.

Process Step Hazard/Cause Controls

11 Sterilization/Cooking Survival of spores of C. botulinum due to under processing

Consistent application of scheduled thermal process based on ‘Brimful’ or guaranteed head space with a minimum product initial temperature. PRPs:

1. SOP Cooker/cooler 2. Trained staff 3. Calibration of

instruments, recorder and alarm

4. Planned maintenance

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STAGE 09 Principle 2

Do this Done it?

Tick it! Detail

DETERMINE CCPs

CCPs agreed by Team

See examples of Decision Trees in Annex 1

PRP support agreed by Team

Decision tree used, copy kept in HACCP Plan

Decision tree not used. System for decision making is recorded

Record kept justifying each decision

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Do this Done it?

Tick it! Detail

ESTABLISH CRITICAL

LIMITS FOR EACH CCP

Critical Limits (CL) established and values VALIDATED with documentary evidence

Record how the CL was determined e.g. set by law, recognised industry standard of GMP, own validated research. If an action is an observation, guidance must be provided on its judgment e.g. documented description, photograph. * Action limits are points that indicate a parameter is moving towards the CL. Action at this point prevents the risk that the CL is exceeded

CL is measurable or observable

CL applies to the CONTROL NOT THE HAZARD

Target, action limits* and tolerances documented where appropriate

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Do this Done it?

Tick it! Detail

ESTABLISH MONITORING

FOR CCPs

1. Monitoring record (MR) indicates WHO is to act

1. Definition: A planned sequence of observations or measurements of control measures.

2. Must be capable of detecting loss of control 3. Should be RAPID enough to take corrective action

in the short term 4. On-line measurements e.g. time and temperature are

better than off-line e.g. can testing or micro tests i. Micro tests are not suitable as they take too long

but are excellent for verification purposes ii. Rapid assessment can give an indication that

something is going out of control 5. Monitoring may be continuous e.g. temperature or

discontinuous e.g. sample collection and analysis i. The latter requires validated sampling techniques

6. Staff must be trained in monitoring i. Need written procedures or work instructions

7. Monitoring records are to be reviewed 8. Monitoring frequency to be sufficient to prevent

unsafe food reaching the consumer

2. MR indicates WHAT to measure and HOW it is done

3. MR indicates WHEN to measure

4. Records are signed by person who carries out the monitoring AND by the person responsible for overseeing the actions

HACCP plan indicates all of 1-4 above

Are PRPs monitored

There is a record of PRPs verification

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Do this Done it?

Tick it! Detail

CORRECTIVE ACTIONS

For CCPs

If monitoring indicates a DEVIATION (failure to meet a critical limit):

i. Stop process ii. Quarantine all product since the last good test iii. Rework if possible iv. Destroy if not possible (unless safe market can

be found)

Immediate actions to regain control are specified.

Root cause investigation procedures are in place

Procedure includes a statement of what happens to product produced since the last good test

Responsibilities are clearly assigned

There is a system for RECORDING the corrective action

Decision makers are specified in procedure

For PRPs

Checks are in place to ensure regular verification

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STAGE 13a Principle 6

Do this Done it?

Tick it! Detail

VERIFICATION: VALIDATION

Validation is undertaken prior to the start of the HACCP plan

CAN-DO! Validation and verification The mnemonic is alphabetic in both pairs of words and means: Can it achieve its objective i.e. has it the capability (whether a piece of machinery or a procedure) = validation Does it achieve it achieve its objective (determined by testing and measurement procedures) = verification

Hazards have been validated

CLs have been validated Monitoring has been validated

Corrective actions validated The plan has been signed off by Team Leader

An approach to verifying the HACCP Plan:

Application of HACCP Principles (7)

Prepare HACCP Plan Validation of plan above

Verify Plan

Implementation of plan

Review activities

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STAGE 13b Principle 6

Do this Done it?

Tick it! Detail

VERIFICATION: VERIFICATION PROCEDURES

Checks are in place to demonstrate compliance with the validated plan

Checks include: 1. Internal audit of CCPs 2. External audit of suppliers 3. Microbiological examinations 4. Results of external audit by customers 5. Complaints analysis 6. Product buy back (purchasing own goods from

retailer to check standards in real-life situation 7. Shelf life tests 8. Deviations and Corrective Actions 9. Analysis of monitoring trends

Verification Checks are in place for every stage of the HACCP

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STAGE 13c Principle 6

Do this Done it?

Tick it! Detail

VERIFICATION: REVIEWS

A procedure for review of the system exists

Reviews are carried out at least annually Plus when changes occur e.g. Internal Raw material changes Raw material supplier changes Process changes Recipe formulation changes External Emergent pathogens Legislation New science/technology Unexpected use by consumers Climate change

Records are kept of validation, verification and reviews

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Do this Done it?

Tick it! Detail

DOCUMENTATION AND RECORDS

HACCP plan, documenting 14 stages

1. Procedures and Work Instructions must be

documented i. Evidence for audit ii. Used for consistent training

2. Records must be: i. Kept for one year longer than the shelf life of the

product and at least 3 years ii. Legible preferably in a language external

auditors can read iii. Retrievable at short notice in case a product

recall has to be affected

Details of hazard analysis

All supporting information/data

Procedures and Work Instructions

Records are retained

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Annex 1 Decision Trees Codex Decision Tree (adapted)

Q1 Is there a hazard at this

process step? No

Yes

Q2 Do control measures exist

No

Yes

Q3 Is this process step specifically designed to eliminate the hazard or reduce it to an acceptable

Yes

No

Not a CCP

Is control necessary for

No Not a CCP

Yes

Modify product or process

Yes Go to next step

Yes

Q5 Will a subsequent process step eliminate or reduce hazard to and

No CCP

Q4 Could contamination occur or increase to an unacceptable level

No Not a CCP

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Campden Simplified Codex Next page: This tree assumes that PRPs are in place

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Annex 2 Definitions Control (noun) The state wherein correct procedures are being followed and criteria

are being met.

Control (verb) To take all necessary action to ensure and maintain compliance with

criteria established in the HACCP plan.

Control Measure Any action to be taken when the results of monitoring, at the CCP,

indicates a loss of control or trend towards loss of control.

Critical Control Point

(CCP)

A process step at which control can be applied and is essential to

prevent or eliminate a food safety hazard or reduce it to an

acceptable level.

Critical Limit A value that separates safe product from potentially unsafe product

(compare with Critical Limit Codex Alimentarius Commission

(2009).

CCP Decision tree A sequence of questions which can be applied to each process step

with an identified hazard to identify which process steps are CCPs.

Deviation A failure to meet a critical limit.

Flow diagram A systematic representation of the sequence of steps or operations

used in the production or manufacture of a particular food item.

Food Operation A company that carries out the preparation, processing,

manufacturing, packing, handling, storage or sale of food products.

HACCP A system which identifies, evaluates and controls hazards which are

significant of food safety.

HACCP Plan A document prepared in accordance with the principles of HACCP

to ensure control of hazards that are significant for food safety in the

segment of the food chain under consideration.

HACCP Team A group of suitably qualified and experienced personnel appointed

by senior management of a food operation to develop and maintain a

HACCP system.

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Hazard A biological, chemical or physical agent in, or condition of, food

with the potential to cause an adverse health effect.

Hazard analysis The process of collecting and evaluating information on hazards and

conditions leading to their presence to decide which are significant

for food safety and therefore should be addressed in the HACCP

plan.

Monitoring A planned sequence of observations or measurements of CCP

control measures. The records of monitoring provide evidence for

future use in verification that the CCP is under control.

Prerequisite

programmes

The measures that provide the basic environmental and operating

conditions in a food operation that are necessary for the production

of safe and wholesome food.

Process step A step is a point, operation or stage in the food chain, including

purchase and receipt of raw materials, from primary production to

final consumption.

Review Scheduled and initiated examination of the HACCP pan to ensure

that it is kept up to date.

Target level A predetermined operational value for the control measure which

has been shown to eliminate or control a hazard at a CCP (see

tolerance below).

Tolerance The value between the target level and the critical limit.

Validation Obtaining evidence that the elements of the HACCP plan (e.g.

controls and critical limits) are capable of being effective in giving

safe product i.e. the HACCP plan is scientifically and technically

sound.

Verification Obtaining evidence that there is compliance with the HACCP plan

and that the implemented HACCP system is resulting in safe

product. (compare with Verification Codex Alimentarius

Commission (2009))

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HACCP Work Sheet 1 Hazard Analysis, Controls and CCP Determination: Codex Decision Tree Step No.

Step description Hazards Control measures CCP Determination Y/N CCP Y/N

Q1 Q2 Q3 Q4 Q5

1 Microbiological

Physical/Foreign Body

Chemical

2 Microbiological

3 Microbiological

4 Microbiological

Note: all three categories of hazard are to be considered as in Step 1 but for our purpose, only consider micro

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HACCP Work Sheet 2 Hazards Controls and CCPs: Risk Based

Step no

Step Hazards Control measures Likely -hood

Severity Total CCP or PRE-REQ?

Record?

1

2

3

4

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Description of the Product Fill in a description of your product and the start and end point of your ownership i.e. the time that you are responsible for its safe-keeping Name of product

Raw material

Ingredients

Storage conditions

Shelf life

Distribution

Start of ownership

End of ownership

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Critical Control Points and Day to Day Control CCP No

Hazard Control Measures

Critical Limit Monitoring/Tests Corrective Action

Verification

Who Frequency What equipment

How equipment used

1

2

3

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HACCP Presentation

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Annex 3 – Audit PPT Presentation Audit PowerPoint Presentation with Work Sheets

Auditing

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Auditing for the Food Industry

Seafood Audit International: www.fishonline.co.uk 1

Richard Chivers

Seafood Audit International

Introduction

Seafood Audit International: www.fishonline.co.uk 2

Aim: By the end of the course the delegates will be competent in:

Preparing an audit

Preparing to be audited

Audit scheduling

Carrying out an audit

Seafood Audit International: www.fishonline.co.uk

3

IntroductionReporting an audit

Audit follow-up and close out


4

IntroductionThe course objectives will start with:

What is an audit?

What do we audit?

Why do we carry out audits?

How do we audit?


5

IntroductionWhen do we audit?

Who do we audit?


6

Introduction

Introduction to auditing

Characteristics of a good auditor

Preparing and carrying out an audit


7

Introduction

Auditing Hazard Analysis systems

Introduction to quality management systems

Auditing quality management systems


8

IntroductionPractical audit of HACCP

Validation of a system

Verification of a system

Writing an audit report

Preparing for an FVO audit

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9

What is an audit?An investigation, a process of collecting data.

Definition: A systematic and independent examination to determine whether activities and results comply with the documented procedures; also whether these procedures are implemented effectively and are suitable to achieve the objectives (Mortimer and Wallace)


10

What is an audit?What do we mean by ‘SYSTEMATIC’?

We mean organized, defined, time-tabled

What do we mean by ‘INDEPENDENT’

We mean free from any influence within the activity being audited


11

What is an audit?Determine whether activities and results comply with documented procedures’

How do you know what an activity comprises?

You need a description of the process limits (beginning and end) and job descriptions of the people carrying it out


12

What is an audit?What results are you to seek?

You must determine what is going to be covered by your audit, then establish the limits or target of the activity you are auditing


13

What is an audit?The second part of the definition refers to procedures and the effectiveness of their implementation

Assess how complete (degree of effectiveness) is the implementation

Assess whether the means used actually allow for a successful outcome


14

What do we audit?Compliance with the national and international law

Compliance with national and international food safety standards

Compliance with good manufacturing practice

Compliance with company intentions

Compliance with quality management systems


15

What do we audit?We audit food safety according to risk

We determine where in food production food safety is most at risk and audit those activities most frequently


16

When do we audit?Audits are either scheduled or unscheduled

Scheduled = timed and booked in with the auditee

In what circumstances would you run an unscheduled audit?

When there is a need for urgency. For example:

A food safety complaint

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17

Who do we audit? Strictly speaking we do not audit people; we audit their functions. However, to obtain information about these functions it is always necessary for us to talk to people, usually those involved with the activity.

What information should you therefore have regarding a person’s activities?

Job description, including responsibilities and line management reporting structure


18

Unscheduled auditsCustomer complaint

FVO adverse inspection

Product turned back at a border inspection post


19

The auditorWhat are the essential characteristics of a good auditor?

1. Trained

2. Has integrity: honesty, sound judgement, open minded

3. Good communication skills: diplomatic, tactful, good judge of significance of issues, identifies priorities

4. Is objective: reports facts not opinions or bias


20

The auditor5. Experienced and/or knowledgeable in the

product category

6. Independent of the activity being audited –auditor must not audit his own function

7. Determined and focussed – people will try to distract you

8. Well mannered


21

The auditor9. Not short-tempered or easy to make angry.

Auditees frequently feel threatened

10. Asks open questions


22

Open questionsWhat is meant by ‘Open questions’

Those that start with the words:

What

Where

Who

How

When


23

Open questionsHere are some examples of open questions:

How do you perform that task?

When would that product temperature be unsafe?

Where would you record the results


24

Open questionsYou can create empathy with questions such as:

How important is it for you to be advised of this type of procedure …?

And clarify points with:

What do you think about that aspect of the process

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25

Open questionsClarify their understanding with hypothetical questions such as:

What if the temperatures were outside the tolerances?


26

Closed questionsThese are questions that allow ‘Yes’ or ‘No’ answers

We do not often use these except when you wish to obtain commitment:

So if this action were taken would complaints/failures fall?

Or when we want to stop someone talking - they do digress when they are nervous !


27

RecapIn this section we have discussed the the reasons why we audit, what the purpose of auditing is and in general terms how we audit.

Any questions?


28

Carrying out an auditIn this section we will cover:

Preparing an audit

Audit scheduling

Carrying out an audit

Reporting and audit

Audit follow-up and close out


29

Auditing – team

How many people do you need to audit a factory?

One or at most two is sufficient


30

Preparing to auditHow do we know when to audit a factory

By the audit schedule

How frequently should we carry out an audit

Frequency is determined by risk

For example?


31

Preparing to audit

High risk activities such as, cleaning/sanitary

procedures and points in the process that are critical to

food safety


32

How long does an audit takeA full audit of a factory’s systems will take 5-10 days but this has to be over a period of months, taking a small part at a time

Normally one or at the most two consecutive days are spent on the job.

However, the audit takes as long as it takes!

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33

What do you arrange with the factory management

What standard they are working to e.g. the law, HACCP, a quality management system?

Who you will meet?

Time table this and ring the week before to ensure everyone is available. If not re-arrange for a few days later


34

Preparing to auditHere are the elements for starting an audit that we have so far:

The team

Timing

The standard to audit to

The names of the company counterparts


35

The audit scheduleWith this information we can create an audit schedule

What is an audit schedule?

A list if timed and structured audits

Put together the elements needed for creating an audit schedule


36

Options for contents of an audit schedule

Date and time

Activity being audited

Standard being worked to

Availability of personnel from the factory

Frequency of audit


37

Examples of audit schedules

First style

Each procedure is allocated a risk assessment against the criteria of safety, legality and quality. In this example the number 2 indicates the activity carries a high risk if it does not comply with the company aims; number 1 a low risk. High risk activities are in this case to have 2 audits per year; low risk, 1 audit per year.


38


Procedure Risk Qtr Qtr Qtr QtrBagging-up and Sealing Procedure 1 x

Cleaning (General) Procedure 2 x x

Complaints Procedure 2 x x

Chilled Storage Procedure 2 x x

Glass and Hard Plastics Procedure 2 x x

Waste Disposal Procedure 1 x


38


Procedure Risk Qtr Qtr Qtr QtrBagging-up and Sealing Procedure 1 x

Cleaning (General) Procedure 2 x x

Complaints Procedure 2 x x

Chilled Storage Procedure 2 x x

Glass and Hard Plastics Procedure 2 x x

Waste Disposal Procedure 1 x


40

Sourcing information Before going into the audit you must have sufficient information. What type and where from?

This will depend on the purpose of the audit but usually:

The standard the company is working to,

Its working procedures and work instructions,

Its hazard analysis

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41

The checklistFrom this information we must build up a checklist of questions to ask and data to collect.

What are the benefits of using a prepared checklist?

Prepares your knowledge of the process

Identifies areas you know too little about

Leaves less chance of missing issues


42

The checklistExamples of what to look for in procedure

Purpose and scope of the procedure

Is it the current issue

What is the purpose of each point

Who is delegated a task

Where the records are kept


43

The checklistUsing the example of a procedure build up a checklist

You may have as many or as few questions as you like

Remember to seek an answer that has a record (or should have a record)


44

The opening meetingThe audit starts with an opening meeting

Those present:

Representatives of management

The person who will co-ordinate the day for you such as the Quality Assurance Manager


46

The audit processUsually the audit takes two parts:

A ‘desk audit’ of paperwork such as procedures and records

A visit to the factory floor where the claims made in the paperwork are tested against the practice


47

The audit processWhat are the essential elements of an audit?

Follow the audit trail: seek proof in the form of records

Do not be side tracked by superfluous information

Use your checklist to remain on track

Take written notes – YOU WILL FORGET ANSWERS!


48

Reporting and agreeing corrective actions

You must have time alone to sum up your findings and write a brief description of the non-compliances in the Corrective Actions Request form

Present these findings, with evidence, to the company representative and agree the actions needed to correct them and prevent them happening again.

Agree a time scale, determined by risk assessment

Leave a copy with the auditee


49

Reporting and agreeing preventative actions

Sometimes it is too late to correct a failure but it may be possible to implement actions to prevent recurrence

A typical example would be the need for re-training

Re-training is something that will affect future performance but can not be an immediate remedy

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50

Follow up and close outFollow up is the process of returning to the audit to ensure the actions agreed have been undertaken satisfactorily

It is not always necessary to physically return to the factory.

What means may we use to verify that the corrective actions have been completed?


51

Follow up and close outFor structural alterations and repairs photographs will suffice.

For repairs to equipment invoices from a qualifiedspecialist will be satisfactory.


52

Follow up and close outWhat about training?

More difficult as proof of compliance may only be possible by speaking to the staff themselves

We can surmount the problem of long distance travel by leaving the final closure until the next audit is due


53

Follow up and close outVerification – the process of testing that compliance is satisfactory

Verification is essential to the closure of a non-compliance. As auditors it is our job to ensure that the solution was the right one to solve the problem


54

Completion of the auditHaving agreed the corrective actions we must summarize the audit progress on the front sheet.


55

Completion of the auditPost audit meeting with: At: (time of day)

Corrective action requests (CAR) closed out

CAR Number Date for completion

Date closed out AuditorSignature on close out

001

002003

Insert date

Insert dateInsert date

Insert date on which you are satisfied that the non-compliance is correctedInsert dateInsert date

Sign

SignSign

Actions completed

YES/NO Auditor signs when all corrective actions are satisfied. The audit is then complete


56

Completion of the auditWhat happens if all actions are not completed by the next audit?

Audit is still open

Reasons are sought and management asked when they expect the problem to be resolved

Significance of the risk involved is considered before a recommendation on extending the deadline is made


57

Audit SummaryA summary of the corrective actions and your general observations is not an essential element of the audit; however, you may find it useful to write your views down to provide a picture of the audit which will remind you and inform later auditors of your opinions in less objective terms than the formal style of audit reporting.

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58

The Finished DocumentYour audit report will comprise:

The audit progress front sheet

The completed checklist with any supporting documentary evidence

Corrective actions signed by both parties

Audit summary report


59

Practical notes How long does an audit take?

As long as it takes!!

Typical timings for 3 procedures would be:1. Reading the procedures 30 minutes

2. Preparing the checklists 1 ½ hours

3. Interviews/factory inspection 1 ½ hours

4. Preparation of reports 1 hour

5. Closing meeting 30 minutes


60

Practical notesIn total 5 hours or at least half a day

A company will often have 20 procedures or more, however, preparation time is shorter for repeat audits as the checklists are already done and you are familiar with the company, its buildings and staff.


61

Practical notesHow long will it take you to audit one business?

Allowing for time for the company to carry out corrective actions, 6 –12 months for a complete assessment of all activities and buildings


62

Practical notesHow accurate do you expect to be in finding the failings in a system?

Experience indicates that in any one audit of a procedure you will find 50% of the non-compliances

So over a series of audits the failings will fall like this:


63

Practical notes= Not found

= Found

Audit 1 Audit 2 Audit 3 Audit 4


64

Cheats and Distractions!You too will be audited. How would you try to put off the auditor so he does not find the weaknesses in your system?

Your client company will try tricks It is part of the fun of an audit! Here are some, with a few responses

1. They turn up late for the opening meeting. The audit takes as long as it takes!

2. They claim documents are not to be found. Ask for them to be faxed to you.


65

Cheats and Distractions!3. The writing in the records appears to be very consistent, suggesting recently written by one person. Check for wet ink.

4. You are given very large folders of records to deal with. Flick through them quickly, gaps in the records become evident almost immediately

5. Claims are made that everyone entering the food preparation area has signed in the visitors log. Ask for maintenance records then check if the engineer signed in on that day.

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66

Cheats and Distractions!6. Upper management assure you that their claims are valid. You may feel pressured but don’t take their word, seek a written record

7. The management take you out for a long expensive lunch! Don’t feel obliged to go easier on them and also carry through all questions on the checklist even if it means finishing late.

8. In the end we all get tired and irritable, take breaks and be generous to your hosts!


67

RecapWe have looked at the theory and described the practice of auditing

We have considered why, what, how, when and who we audit.

We have found that auditing is a non-aggressive helpful partnership between two parties seeking to improve a company’s performance.

An audit will work smoothly if it is properly prepared


68

Recap

A final thought, remember when auditing your own organization that one day the person you are auditing will be auditing you. Be fair, be generous!


69

Thank youRichard Chivers

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Hand-out 1

Understanding Audit: the Definition Given this definition of auditing: Auditing: A systematic and independent examination to determine whether activities and results comply with the documented procedures; also whether these procedures are implemented effectively and are suitable to achieve the objectives (Mortimer and Wallace) Systematic and Independent What do we mean by ‘SYSTEMATIC’? We mean organized, defined, time-tabled What do we mean by ‘INDEPENDENT’ We mean free from any influence within the activity being audited Activities and Results of Activities How to know when an activity has been successfully carried out: The auditor requires a description of the process limits (beginning and end) and job descriptions of the people carrying it out What results do you seek You must determine what is going to be covered by your audit, then establish the limits or target of the activity you are auditing Assess effectiveness of procedures Assess how complete (degree of effectiveness) is the implementation Are procedures suitable Assess whether the means used actually allow for a successful outcome

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Hand-out 2 The Auditor: When and Who Consider planning an audit then put down bullet points under these headings: When do we audit? (Hint: think of trigger points that would require an audit of a factory, a process within a factory or an event in your own department) Who do we audit? (Hint: do we audit people, their jobs or the organisation?) Hand-out 3 The Auditor: Characteristics What characteristics would you expect to find in a good auditor? (Hint: Try for 10) Hand-out 4 Step 1/9 The Audit: Pre-audit preparations What would you expect to read, to make clear to the auditee and carry with you prior to leaving the office?

CA Responsibility: Director

Procedure: Internal audit Accountability:

Issue No: 1 Date: 06/09/2013 Controlled Copy No:

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1. Purpose

To describe the audit arrangements for ensuring that systems and procedures are in place, appropriate and are working accordingly.

2. Scope

Audits of those systems and procedures required for the Competent Authority to implement official controls over food businesses

3. References

None

4. Definitions

CAR – Corrective Action Request

5. Procedure

5.1 Audit Schedules are prepared. These schedules are approved by the (……. Director, perhaps, whoever you think best) to ensure that all the applicable elements of the management system (procedures, certificates and standards) are audited at an appropriate frequency which reflects the status and importance of each element.

5.2 The Auditor contacts the Manager to agree a mutually convenient date for

the audit.

5.3 An Audit Progress Form is raised for each audit.

5.4 Upon completion of the audit the objective evidence and apparent non-conformances are evaluated and their validity as audit findings confirmed.

5.5 Any Corrective Action Requests, (CARs), are prepared on the CAR Form.

The non-conformance, the root causes and the proposed date of completion of the Corrective/Preventive actions are discussed and agreed with the Auditee.

5.6 CARs are signed by the Auditee.

5.7 The dates for completion of CARs are entered on the Audit Progress Form.

CA Responsibility: Director

Procedure: Internal audit Accountability:

Issue No: 1 Date: 06/09/2013 Controlled Copy No:

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5.8 An Audit Report is prepared following completion of the audit using the Audit report form.

5.9 The status of the action required by the CAR is checked by follow-up on or after the agreed dates for completion.

5.10 If the action is determined to be completed and has been effective the CAR

Form is signed off and placed in the audit file. The CAR is then considered to be closed.

5.11 CAR Progress is noted on the Audit Progress form as CARs are closed.

5.12 If, on follow-up the action has not been done or is deemed to be ineffective

then the fact will be noted on the CAR and dated.

5.13 A report is prepared for Management Reviews on the performance of the Audit Corrective action system.

5.14 ‘Cross auditing’ if appropriate is arranged by the Directors.

6. Appendices 6.1 Sample copy of Audit progress form 6.2 Sample copy of CAR form

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AUDIT PROGRESS Audit Title :

QA Document :

Audit Team :

Type of Audit Scheduled/Unscheduled/Compliance/Improvement*

Post Audit Meeting with CAR’s Closed Out CAR No Date for

Completion Date Close Out

Signature on Close Out

Actions completed? YES/NO Signature

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CORRECTIVE ACTION REQUEST

Car No. : Issued to : Issued by : NON – CONFORMITY IDENTIFIED

ROOT CAUSES OF NON-CONFORMITY

SYSTEM IMPROVEMENTS AGREED BETWEEN AUDITOR AND AUDITEE Proposed Completion Date:

Auditee Signature: Date :

VERIFICATION OF SYSTEM IMPROVEMENTS:

Date Results

Auditor Signature : Date :

Copies to: Auditee File

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Annex 4 – Reg 882 2004

Reg 882 2004

ANNEX II COMPETENT AUTHORITIES

CHAPTER I: SUBJECT MATTER FOR THE TRAINING OF STAFF PERFORMING OFFICIAL CONTROLS

1. Different control techniques, such as auditing, sampling and inspection

2. Control procedures

3. Feed and food law

4. The different stages of production, processing and distribution, and the possible risks for human health, and where appropriate for the health of animals and plants and for the environment

5. Assessment of non-compliance with feed and food law

6. Hazards in animal feed and food production

7. The evaluation of the application of HACCP procedures

8. Management systems such as quality assurance programmes that feed and food businesses operate and their assessment in so far as these are relevant for feed or food law requirements

9. Official certification systems

10. Contingency arrangements for emergencies, including communication between Member States and the Commission

11. Legal proceedings and implications of official controls

12. Examination of written, documentary material and other records, including those related to proficiency testing, accreditation and risk assessment, which may be relevant to the assessment of compliance with feed or food law; this may include financial and commercial aspects

13. Any other area, including animal health and animal welfare, necessary to ensure that official controls are carried out in accordance with this Regulation.

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CHAPTER II: SUBJECT AREAS FOR CONTROL PROCEDURES

1. The organisation of the competent authority and the relationship between central competent authorities and authorities to which they have delegated tasks to carry out official controls

2. The relationship between competent authorities and control bodies to which they have delegated tasks related to official controls

3. A statement on the objectives to be achieved

4. Tasks, responsibilities and duties of staff

5. Sampling procedures, control methods and techniques, interpretation of results and consequent decisions

6. Monitoring and surveillance programmes

7. Mutual assistance in the event that official controls require more than one Member State to take action

8. Action to be taken following official controls

9. Cooperation with other services or departments that may have relevant responsibilities

10. Verification of the appropriateness of methods of sampling, methods of analysis and detection tests

11. Any other activity or information required for the effective functioning of the official controls.

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Annex 5 – Documents consulted Biodiversity Hazards – Documents reviewed, web sites visited and email contacts Documents Reviewed A Review of the South Pacific Tuna Baitfisheries- Small Pelagic. Dalzell, P. and Lewis, D. 1989 Aquatic animal health subprogram program 2006 herpesvirus. Jones, B.; Crockford, M. Whittington, R. Crane, M. Wilcox, G. October 2006 FRDC Project No. 2002/044 Aquatic_Animal_Health_RD_Plan_2010-2012. Crane, M. FRDC 2009 Ver 1.0 Australian Fisheries Statistics 2009 (no issue identified at this point) Australian Sardinops: Environmental & biological aspects of pilchard mass mortalities 1995. Fletcher, W.J., Jones, B., Pearce, A.F., Hosla, W. Oct 1997. Fisheries Dept. of Western Australia Baitfish of New York. www.dec.ny.gov Perspectives in Aquatic Exotic Species Management in Pacific Islands. Eldredge, L.G. Pacific Science Assoc. SPC 1994 IFRP7 Disease-translocation across geographic boundaries must be recognized as a risk even in the absence of disease identification: the case with Australian Sardinops. Gaughan, D. Reviews in Fish Biology and Fisheries 11: 113–123, 2002 EU fisheries_research_organisations. 2000 Gillett-Baitfish-Jan-22-2010. International Seafood Sustainability Foundation Gillett-PAc-purse-seine-to-pole-tuna-MarinePolicy-in press. Aug 2010 International Union for Conservation of Nature. IUCN Guidelines for the Prevention of Biodiversity Loss Caused by Alien Invasive Species. 2000 Main bacterial fish diseases in mariculture. Toranzo, A., Magarinos B., Romalde, L. Dec 2004 Movement patterns and stock structure of Australian sardine Sardinops sagax off South Australia and the East Coast implications for future stock assessment and management. Izzo, C., Gillanders, B., Ward, T. March 2012 FRDC Partial characterisation of PHV. Crockford, M. 2007 Pilchard Mortality Events in Australia and Related World Events. Gaut, A. FRDC 99/227

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Regrowth of (Sardinops sagax) stocks after mass mortalities 1998/99. Gaughan et al Fisheries Research Report 176, 2008 Review of the biology and fishery for Australian sardine (Sardinops sagax) in New South Wales 2010. Industry & Investment NSW- Fisheries Research Report Series 26 Risk on local fish populations and ecosystems posed by the use of imported feed fish by the tuna farming industry in the Mediterranean. WWF 2005 ‘Selling the untold wealth in the seas’ Gowers Richard, J. May 2008 Websites visited WWF worldwildlife.org/ Cefas. Centre for Environment, Fisheries and Aquaculture Science www.cefas.defra.gov.uk/ Cefas. Weymouth Laboratory. The Nothe, Barrack Road, Weymouth, Dorset DT4, 8UB Animal Health and Veterinary Laboratory Agency (Department of the Environment, Food and Rural Affairs, www.defra.gov.uk/ahvla-en/ American Ichthyology and Herpetology Society. www.asih.org/ FAO. www.fao.org/ Seafood Listserve. Members only EU: Fisheries Research organisations in Europe, Norway, Iceland and Israel Wageningen UR Corporate headquarters. www.wageningenur.nl/en/Contact-Wageningen-UR.htm Russian fisheries and aquaculture research organisations. http://fp7-bio.ru/en/tp/russian/fisheries.php International Union for Conservation of Nature http://www.iucn.org/contact/iucn_offices/ Russian fisheries and aquaculture research organisations American fisheries and aquaculture research organisations European fisheries and aquaculture research organisations Google questions asked were framed in this manner: Fish disease spread in the open ocean Risks to biodiversity from imported tuna bait Risks imported tuna baitfish Australia South African sardines Sardine mortality Australia (most productive) Tasmanian Salmonid Growers Assoc (Useful risk assessment system)

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Annex 6 – Workshops Workshops on International Trade Issues and Standards for Solomon Islands Project ref. N° PAC-4.1-B18b Wrap-up meeting of Technical Team 13th September 2013 Training ToR 1. Work closely with the TT and following consultations with relevant stakeholders, build an understanding of the target group for each of the proposed trainings and devise a series of learning objectives to meet the target audience; 2. Work closely with the TT to adapt existing materials and references, or prepare new ones where necessary, in the light of the results of the previous activity, to ensure that the training materials and methods meet the needs and expectations of the target groups and will build on their existing capacity. 3. Provide training for staff from the fishing industry in an introduction to HACCP and auditing (indicatively for 40 people for 6 days (2 days Honiara, 4 days Noro)). 4. Provide audit training for CA officers and an introduction to the EU regulations and the Eur-lex website (5 staff 2 days Honiara, 1 day Noro). Private Industry Participating companies: Southern Seas Investments Ltd, Soltuna Ltd and NFD Ltd Learning objectives:

1. To introduce staff at each of the companies to the concepts of HACCP; 2. To prepare staff at SSI specifically for developing their own HACCP as the current version is

‘borrowed’ from their Vanuatu plant

a) At Soltuna to review the understanding of HACCP that QC staff b) To provide an introduction to HACCP terms and develop an overall picture of its purpose for

staff not directly involved with fish processing e.g. stevedores, security guards, fishermen. c) To review the company’s existing HACCP plan the Soltuna’s head of QC

1. With NFD Ltd to provide an introduction to HACCP terms and develop an overall picture of its

purpose for staff not directly involved with fish processing e.g. fishermen. 2. To review the HACCP plan with the NFD Fresh and Frozen Manager Cynthia Wickham

Methods

1. PowerPoint Presentation on HACCP development along with worked examples. Worked examples were the preferred method of putting this information across as it leads to a better understanding of the actual paperwork involved.

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2. In the case of SSI whose HACCP was in need of further development a 25 page booklet was produced to be an active checklist i.e. it is photocopyable and provides all the questions a business needs to create an HACCP plan.

Results 32 members of staff at Soltuna and NFD provided with training as requested. All reports on training were good, with very positive comments from the MD Adrian Wickham, General Manager Jim Alexander and Fresh and Frozen Manager Cynthia Wickham. CA Learning objectives: 1. At Honiara review the audit principles. 2. Prepare ground for scheduled internal audit of the CA official controls. 3. Carry out an introduction to EU legislation through the Eur-lex web site. Methods 1. PowerPoint Presentation on auditing skills and internal audit. 2. The National Control Plan (NCP) was used as the model for developing procedures that

describe the day-to-day work carried out by the department. Once these have been written it will be possible for audits of official controls over fish exports to be evaluated. An audit schedule is to be prepared once all the procedures have been completed.

3. Working on the internet with the Eur-lex web site. Practical application of skills including, bringing up and saving pieces of legislation and seeking the most recent ‘Consolidated’ versions of each document.

Results Training carried out with a high degree of interest shown by all CA officers. All participated in preparing procedures from the NCP. All were given instruction on how to access the Eur-lex website and download the most recent versions of the legislation. Meeting ToR Facilitate a meeting between members of the CA and MFMR inspection staff to review inspection procedures (2 days). Result Due to time constraints at the MFMR the meeting could not take place. However Judith Reynolds has prepared an excellent presentation on the work and skills of her department, which she is keen to use as a basis for the meeting when it is rearranged in the near future. The consultant used the time allocated to the meeting for further investigation of the biodiversity research Biodiversity Risk Analysis ToR Carry out a risk assessment review of microbiological hazards of imported baitfish and make recommendations (2 days).

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Method A risk assessment was carried out through internet research on the subject and through email to possible sources of information, including personal contacts. Results It was found that the source of concern were two epizootic events of mass mortalities in Australian sardines (Sardinops sagax) in 1995 and 1998 that were caused by the pilchard herpesvirus (PHV). The vector for the virus is unknown but the three most likely possibilities were:

a) Seabirds b) Water from vessels’ ballast tanks c) Frozen pilchards used for in the feed in the bluefin tuna farming industry

That the virus had lain dormant in the pilchard stock was also considered but thought to be unlikely. Though no final proof was found, the baitfish industry supplying bluefin farms did appear the most likely source of the virus. Pilchard stocks have returned to normal and the virus is now endemic in the pilchard population of south of Australia. With no further epidemics, it is believed that the fish have acquired immunity and there will not be any mass fatalities in the future. For the Solomon Islands, where frozen baitfish is used by the longlining industry, the significance for local fishing interests depends on the commercial and ecological importance of small pelagics in the region and how susceptible they are to this disease. There seems little doubt that PHV could be spread by the import of baitfish and that may be the only disease worth seeking solutions for at present, given that there may be many more pathogens both viral and bacterial in other parts of the world that could impact on the regional fish stocks. Certainly imports could be tested for PHV and this may be a route the Government would wish to take. On the other hand, if the events in Australia were caused by contaminated feed in the offshore bluefin farms, the quantities and concentration rate of viral particles in the ocean would be very different from the single pieces used on hooks in the longline industry. The research into PHV indicated that there might be a level of contamination with the virus that the individual pilchards can survive. Taking these points into consideration and analysing likelihood of occurrence against severity, suggests that use of contaminated pilchards for longlining in the open ocean would create a hazard of low to medium significance. Work is recommended on:

a) Research into the resistance of Solomon Islands pelagic species to PHV. b) The development of protocols aimed at quarantining baitfish from inshore waters e.g. not

allowing dumping of waste fish, washing baitfish containers at sea. c) Development of a testing regime for PHV in imported baitfish d) Require suppliers to present verifiable evidence that PHV is not present in their supplies.

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Annex 7 – Itinerary, institutions and individuals consulted

Day/date Activity People met M 19/8 Tech Team Meeting Hugh Walton FFA

Judith Reynolds Head of CA Jonathan Peacey MFMR Dale Hamilton PHAMA Edward Honiwala Deputy Director MFMR Primo Ugulu Secretary to Board of Tuna Industry Association Solomon Islands Nollen Lennie NFD

T 20/8 Redesigning ToR Meeting with EU Delegation

Members of TT Lorena Elvira Ayuso

W 21/8 Organising meeting MFMR/CA Members of TT Th 22/8 Meeting Simon Diffey, Team Leader Institutional

Development Advisor F 23/8 Meeting with Ministry of Trade

and Foreign Affairs Ken Rodwell (TT could not make the original meeting)

Sa 24/8 Preparation of training materials

Su 25/8 Visit to SSI factory and vessel unloading, Honiara

Jun Bolivar Factory Manager SSI Julian Dung Office Manager SSI

M 26/8 Training preparation T 27/8 Training SSI SSI Staff W 28/8 Training SSI SSI Staff Th 29/8 Training Auditing/Legislation CA Staff Honiara:

Judith Reynolds Manager CA Ethel Mopolu Chief Health Inspector Patricia Soqoilo Health Inspector

F 30/8 Training Auditing/Legislation CA Staff Honiara Sa 31/8 Preparation of materials for Noro

training events Meeting Soltuna representative

Frank Wickham, Manager Soltuna

Su 1/9 Fly Noro M 2/9 Training HACCP Adrian Wickham Managing Director Soltuna Ltd,

Jim Alexander, General Manager Soltuna Peter Soni Maria Jacob, QC Manager Soltuna Cynthia Wickham, Chilled and Frozen Manager NFD Ltd Soltuna Staff.

T 3/9 Training HACCP Soltuna Staff W 4/9 Training HACCP NFD Staff Th 5/9 Training HACCP NFD Staff F 6/9 Training Auditing/Legislation CA Inspectors Noro:

Christina Mamupio Mark Arimalanga

Sa 7/9 Collate training results/Fly Honiara

Su 8/9 M 9/9 Prepare meeting CA/MFMR and

final TT meeting

T 10/9 Biodiversity Research W 11/9 Biodiversity Research

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Day/date Activity People met Th 12/9 Biodiversity Research F 13/9 Wrap-up Meeting TT Judith Reynolds, Patricia Soqoilo, Dale Hamilton Sa 14/9 Collate information from

meetings, research etc.

Su Fly Australia/Hong Kong/UK