sgf-gmp self assessment questionnaire en

SGF-GMP- Self assessment questionnaire(for increased food safety, in particular in the fruit juice industry)

Introduction In the last decade, manufacturers in the food chain (including the fruit juice chain) have been required, by their customers, to complete an ever increasing number of self assessment questionnaires They are often used to provide an initial evaluation but their use can also be a 3rd party stipulation e.g. a requirement of a certification body. Questionnaires used to be relatively simple and short but the last couple of years have seen them becoming more and more detailed, sometimes a couple of hundred pages long. They normally cover all relevant aspects of a food business operation, Quality Management, Good Manufacturing Practice, HACCP, Traceability, etc. - the same items are addressed in most questionnaires. Where they differ is in the details and in the phrasing of the questions. This makes their completion a very time consuming job. SGF International e.V. has been asked by their members to produce a standard Self Assessment Questionnaire and to seek acceptance within the fruit juice chain for its use. This SGF-GMP Self Assessment Questionnaire is a result of the Working Group “Mutual recognition of audits and certification systems“. The Working Group compared a number of frequently used self assessment questionnaires, the IFS and BRC standards and supplier’s own audit checklists to make a compilation of most of the relevant questions contained within these documents. We believe strongly that this standard self assessment questionnaire covers at least 90-95% of all questions found in the questionnaires we used as benchmarks. If your customers accept this standard questionnaire and do not request the completion of any own questionnaires, you need to fill in only one questionnaire. This saves a lot of time for you. On the other hand you can send it to your suppliers and you will be able to evaluate their replies much easier due to the standardized format. Additional questions, those not found in the standard questionnaire, can always be asked as a separate exercise but these should be few in number and therefore rapid in response. In the future the SGF-GMP Self Assessment Questionnaire will be subject to periodic revision and amendment to include any additional, commonly asked questions. All operators in the fruit juice chain (from raw material processors to retailers) are asked to use and accept this SGF-GMP Self Assessment Questionnaire as a basic document.

1. Version;.August 08, 2008

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1 :

1.1 :

Telephone No. :

Fax No :

E-mail :

Website :

Please note - EACH PRODUCTION SITE REQUIRES ITS OWN QUESTIONNAIRE TO BE COMPLETED :

Registration No. Site :

Telephone No. :

Fax No :

E-mail :

Website :

1.2 :Name

: :: :: :: :

(for increased food safety, in particular in the fruit juice industry)

Phone, Fax, e-mail

Company Name

Address office - Corporate Office / Head Office / Administrative Office

Address office - Production Site

ManagementSGF Contact Person

Responsibilities

SalesProduction / Technical Department

SGF-GMP- Self assessment questionnaire

1. Version; August 08, 2008 2/22



: :

: :

Emergency contact person :

1.3

Product Range Harvesting Period

: : :

: : :

: : :

: : :

: : :

1.4

Number of Employees :

Permanent :

Temporary :

Contract :

Number of employees

Estimated Quantities

Product range / Harvesting period / Estimated Quantities

Quality Management / Assurance

Logistics




1.5 YES NO

DOC Flow chart existing - made available to customers. Please provide copyExtraction systems

Evaporation systems

Tank capacities

Ambient temperature tanks

Sterile tanks

Cooling tanks

Deep frozen storage

1.6 YES NO

National associations - please list

International associations - please list

1.7 YES NO

Existing - please provide details

1.8 Social (ethical) standards YES NO

DOC Is there a social accountability statement and policy in place? Please provide a copy of the written document.

REMARK

Technical Information's Remark

REMARK

REMARKCurrent membership in organisations

Company brochure + website


YES NO REMARKS

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2.1.1 Is there a quality management system in place?2.1.2 DOC

Is it certified by a recognised 3rd party? Please provide a copy of the latest certificates.

2.1.3 If there is no certified system in place, is one planned? Which standard? When will it be fully implemented?

2/22.2.1 Does a quality manual exist?2.2.2 Is it available to all staff & customers?2.2.3 Does the quality manual contain reference to HACCP

analysis?2.2.4 At what frequency is the HACCP system audited to ensure

its continued effectiveness?2.2.5 DOC

Has the management documented and communicated a clear quality policy that includes the idea of continual improvement in effectiveness? Please provide a copy of the current quality policy

2.2.6 Does the quality policy include responsibility to the environment, hygiene and ethical aspects?

2.2.7 How is this policy communicated to the employees?2.2.8 Is there an effective document control procedure in place?

2/32.3.1 Who does the quality manager report to?2.3.2 DOC

Is there a document that details the management structure? Please provide a copy.

SGF-GMP - Self assessment questionnaire(for increased food safety, in particular in the fruit juice industry)

Quality Management SystemInformation about the Quality Management

Quality Manual

Quality Management Representative

1. Version; August 2008 5/22

YES NO REMARKSSGF-GMP - Self assessment questionnaire(for increased food safety, in particular in the fruit juice industry)

2/42.4.1 Is your quality system fully documented?2.4.2 Are specifications available for all raw materials?2.4.3 Are specifications available for packaging materials suitable

for foodstuff?2.4.4 Are there cleaning schedules available?2.4.5 Is there a documented procedure for the release of your

finished product?2.4.6 Who is responsible for final product release?

2/52.5.1

2.5.1.1 Does the HACCP system cover all aspects of the manufacturing process?

2.5.1.2 Has it been certified?2.5.1.3 DOC

If yes, please state the name of the certification body. Please provide a copy of the latest certificate(s).

2.5.1.4 Has the HACCP hazard analysis taken into consideration microbiological, chemical & physical hazards?

2.5.1.5 Have critical limits been set for all the Critical Control Points (CCPs)?

2.5.1.6 Are procedures in place to monitor these critical limits?2.5.1.7 Are records available of this monitoring activity?2.5.1.8 Has it been verified that the control measures are effective?

2.5.1.9 If monitoring indicates that a critical limit for an identified CCP has been exceeded, have corrective procedures been established?

Documentation of Quality, Hygiene, Relevant Processes & Work Flows

HACCP SystemHACCP



2.5.22.5.2.1 Is there a complete HACCP Team existing with defined

responsibilities & authorities?2.5.3

2.5.3.1 DOC

Do you have a process flow diagram that indicates the location and nature of all the CCP's? Please provide a copy.

2.5.3.2 Has the intended use of the product by an end user / customer been taken into account?

2.5.3.3 How is the HACCP plan reviewed to allow for changes to the process?

2.5.3.4 How does the management ensure that the HACCP analysis is based on sound scientific / technical data relevant to the products and processes used?

2.5.3.5 Does the current flow diagram accurately reflects the current manufacturing process?

2.62.6.1 Are training programs in place for all employees?2.6.2 For how long are training records kept?2.6.3 Are workers trained and skilled on the job?2.6.4 Are all employees trained in personal hygiene ?2.6.5 If yes, are training procedures and training records

available?2.6.6 Is there a review of the effectiveness of training and

refresher training courses given on a periodic basis (training records)?

2.6.7 Are temporary & external contract persons employed on the basis of appropriate education, training, skills and experience?

HACCP Team

HACCP Analysis

Training Programs



2/72.7.1 DOC

Are schedules for internal audits avalable? Please provide copy.

2.7.2 Does the personnel perform any work that affects product safety, legality and quality have the required competence by education, work experience and/or training?

2.7.3 Are records available of the scheduled internal audits, the associated corrective actions and the subsequent verification activities?

2.7.4 How long are records of internal audits retained?2/8

2.8.1 Are all purchased raw materials, ingredients, additives and packaging materials in compliance with local regulation and the legislation in the country of destination?

2.8.2 Do you have a supplier selection procedure?2.8.3 On what is it based?2.8.4 Are any external processes in place which are done by 3rd

parties?2.8.5 Is there a special procedure in place to monitor any

outsourced production, ie production carried out at another locations?

2.8.6 Is there a procedure in place to control the use of rework / reprocessing to ensure safety, legality and quality, as determined in the specification of the finished product?

Purchasing

Audits



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3.1.1 Is the processing plant located in an area that poses no threat to the environment and to food safety?

3.1.2 Does the internal design and layout of the processing plant permit good food hygiene practices and protection against cross contamination of the product?

3.1.3 Does the company investigate to what extent the factory environment (e.g. ground, air) may have an adverse impact on product safety and product quality? What measures have been established to reduce the impact? Will the efficiency of the measures be periodically reviewed (examples: extremely dusty air, strong odor)? Please explain.

3/23.2.1 Does the design of the process flow, from intake to

dispatch, prevent the contamination of raw material, packaging, intermediate/semi-processed and finished products?

3.2.2 Is there a segregation between high and low risk operations to minimise the risk of product cross contamination?

3.2.3 Is the cleaning / washing facility for crates, utensils, trays etc completely segregated from other production activities?

Premises, Grounds, Location

Layout / Product flow

Good Manufacturing Practices



3/33.3.1

3.3.1.1 Where there is a risk of contamination, does production take place entirely within enclosed buildings?

3.3.23.3.2.1 Are walls designed, finished & maintained to prevent the

accumulation of dirt and the reduction of condensation and mould growth?

3.3.2.2 Are the junctions between the walls and the floor sloped to facilitate cleaning and avoid mould growth?

3.3.2.3 Are there openings in the walls/ceilings through which animals, insects and birds could enter the production area?

3.3.33.3.3.1 Are floors made of alkali and acid resistant material?3.3.3.2 Do the floors have sufficient slope to avoid water

stagnation?3.3.3.3 Are the floors cleaned and maintained regularly?

3.3.43.3.4.1 Are ceilings designed, constructed, finished and maintained

so as to prevent the accumulation of dirt, the reduction of condensation and mould growth and to facilitate easy cleaning?

3.3.53.3.5.1 Are drains adequately designed to handle the volume of

waste water etc?3.3.5.2 Are all drains fitted with screens and waste traps to prevent

pest entry into the processing areas. 3.3.5.3 Are the drains cleaned and maintained regularly?

FabricBuilding - Production Area

Ceiling

Drainage

Walls

Floors



3.3.63.3.6.1 Are fly screens in place on all openable windows ?3.3.6.2 Are all glass windows either shatter-proof or protected

against breakage in other ways?3.3.7 Doors

3.3.7.1 Are all access points into the production areas protected against birds and flying insects?

3.3.7.2 Are all doors in the production environment made of safe, hygienic, easy to clean materials (not of wood or glass)?

3.3.83.3.8.1 Is the lighting provided in all work areas adequate for the

activity taking place?3.3.8.2 Are all glass bulbs and strips lights that constitute a risk to

the product, including those on electric fly killer units, protected by shatter-proof plastic diffusers or sleeve covers? Note: For high temperature lights, where plastic covers are not viable, suitable material has to be used.

3.3.93.3.9.1 Does adequate natural and/or artificial ventilation exist in all

areas?3.3.9.2 Are ventilation systems installed so that filters and other

components which require cleaning or replacement are easy accessible?

Ventilation

Windows

Lighting



3.3.103.3.10.1 Is all water, coming into contact with the product, potable

(including steam, ice and condensate)?3.3.10.2 DOC

Are there flow diagrams available for all "process waters" used in the production process, where they are used and what treatments take place? Please provide copy. Note - process waters include the following: bore whole, municipal, softened, deionised and condensate.

3.3.10.3 Provide details of the frequency and nature of all tests performed on the process waters.

3/43.4.1 Is the equipment positioned for ease of cleaning and

maintenance?3.4.2 How has the equipment been validated to ensure constant

production of safe and legal product?3.4.3 In case of equipment failure or process deviation, is there a

procedure in place to decide if the product is still safe to release?

3/53.5.1 Does the plant identify the measurements critical to

food safety and the measuring and monitoring devices required to assure product safety?

3.5.2 Are all the measuring and manufacturing devices that have a significant role in product safety and quality calibrated (records, calibration certificates / stamps)?

Water supply

Equipment & Maintenance

Calibration, Control of Measurement and monitoring Devices



3/63.6.1 Are appropriate waste disposal facilities available? 3.6.2 Are waste containers for inside and outside purposes

clearly identified, cleaned and disinfected?3.6.3 Does the waste disposal system meet legal requirement?

3/73.7.1 Are there designated areas where smoking, eating and

drinking are allowed? 3.7.2 Are changing rooms provided for workers, staff, visitors or

contractors for changing into working clothes before production area ?

3.7.3 Are there toilets and suitable washing facilities, including sanitary agents, disposable towels and hand dryers provided?

3.7.4 Is there direct access to production rooms from these facilities?

3.7.5 Are there visible "Wash Hands" instructions available before entering the production areas?

3.7.6 Are there visible rules to prohibit smoking, eating & drinking in the production area ?

Waste / Waste Disposal

Sanitary Facilities



3/83.8.1 Are there instructions on how to be suitably dressed to enter

the production areas (aprons, head coverings gloves etc)?

3.8.2 a) Are working clothes available?b) If yes, are they removed after visiting high risk area?

3.8.3 Is there a specially designated changing room before entering the high risk area?

3.8.4 Is protective clothing laundered effectively on a regular basis?

3.8.5 Is suitable footwear worn within the factory environment and waterproof footwear in high risk production area?

3.8.6 Are aprons, head coverings, gloves being used and stored in separate area after use?

3.8.7 Are there instructions to remove loose items when entering the production areas eg jewellery, rings, watches, pens etc?

3.8.8 Are there any regulations on the behaviour of employees in case of illness?

3.8.9 Must all skin defects eg cuts, boils, grazes be covered by moisture-proof plasters before entering the production areas?

3.8.10 Are blue plasters with a metalized strip used for easier detection in the product?

3.8.11 How are people suffering from infectious diseases (jaundice, diarrhoea, vomiting, fever, sore throat, discharges from ears, nose and eyes) controlled and excluded from the processing areas?

3.8.12 Do workers handling produce have short, clean fingernails, no varnish, lacquer or false nails?

Personnel Hygiene



3/93.9.1 Is there a pest control system implemented?3.9.2 How are pest control and pest prevention measures

implemented and their effectiveness monitored?3.9.3 Are there records available about pest control AND pest

prevention? 3.9.4 DOC

Are traps for rodents, insects and all other relevant pests in place? Please provide a map indicating the location of all traps and insecticutors.

3.9.5 Are the incoming raw materials, where applicable, checked on arrival for the absence of pest infestations?

3.9.6 Do traps / bait stations inside the production area contain any poison that can leave the container?

3.9.7 Is vegetation allowed to grow near the production areas that could provide cover for pests?

4

4/14.1.1 Do you have cleaning schedules, procedures and

records for the following: Exterior surroundingsBuilding (External)Building (Internal)Equipment

4.1.2 How do you evaluate the effectiveness of cleaning and disinfection agents eg against Alicyclobacillus spores?

4.1.3 Are specifications for all cleaning agents used available?4.1.4 Is there secure & separate storage for chemicals and

detergents? 4.1.5 Are all cleaning chemicals used according to the

manufacturer's instructions?

Pest Control

Cleaning Schedules

Cleaning Schedule, Time & Temperature, Contamination Risk, Product Analysis



4/24.2.1 DOC

Do you have established time and temperature programmes that have been shown to produce a microbiologically stable product? With regards to: (please provide relevant documentation).a) Water activity & pH of the product?b) Likely initial levels and types of micro-organisms?c) Intended shelf life of product, method of packing and method of processing?

4.2.2 Does the programme cover hot and cold processes?4.2.3 DOC

Do you have any temperature & time tolerances? Please provide a copy of the method of evaluation.

4.2.4 Are there any automatic systems in place in the event of failure?

4/34.3.1 What is the calibration frequency for all equipment used for

quantity measurement (weights)?4.3.2 How is this calibration data recorded?

Process / Temperature / Time control

Quantity Control



4/44.4.1 Are there appropriate procedures & processes to control the

risk of physical & chemical contamination of product?4.4.2 Are filters and sieves inspected regularly and records

maintained?4.4.3 Is there a wood & glass elimination policy?4.4.4 Are there written procedures for handling wood, glass, hard

clear plastic, metal & knife breakages in the factory?

4.4.5 Where is the fruit for processing coming from (e.g. packing houses, orchards, etc.)?

4.4.6 Is there a metal / foreign body detector installed in-line for ferrous & non-ferrous metal with an alarm?

4.4.7 DOC

Is the sensitivity of the metal detector calibrated according to the products and recorded? Please provide records of the last calibrations.

4.4.8 What procedure is in place to ensure traceability of the incoming fruit?

4.4.9 Is there an inspection procedure for all incoming fruit deliveries?

4.4.10 Are fruits received according to legal requirements including pesticides & heavy materials?

4.4.11 Does the wash water contain any added chemicals (eg. Chlorine, tensides etc.)? If yes please provide details.

4.4.12 How is the level of added chemicals controlled?4.4.13 Is there a final, chemical free washing step (e.g. with

potable, evaporator water etc.) prior to further processing?

4.4.14 How is the quality of the final fruit cleaning water monitored?

Fruit Washing

Control of Product Contamination

Fruit Acceptance



4.4.15 Are there appropriate sorting processes / equipment to remove unsuitable fruit and foreign matter?

4.4.16 Are there instructions available regarding the removal of unsuitable fruit?

4.4.17 Are the following systems such as sieves / filters, mixing tanks, keg filling equipment etc. closed systems? Are they all protected against foreign matter contamination from the environment?

4.4.18 Are pipelines and hoses clearly marked according to the products to be conveyed?

4.4.19 Is there a system of planned maintenance in place covering all items of equipment which are critical to product safety, legality and quality?

4.4.20 Does this system identify who is responsible for performing the maintenance and who is responsible for making sure the work has been carried out?

4.4.20 Are all oils and lubricants, that could come into contact with the product, food-grade?

4.4.22 Does the maintenance of all items of process equipment coming into direct contact with the product ensure that there are no sources of product contamination eg metal shards, broken belts, lose nuts and bolts, old grease, blocked and overflowing drip trays etc.

Contamination - Maintenance

Fruit Sorting

Fruit Extraction

Pipelines / Hoses



4/54.5.1 Are appropriate microbiological, physical and chemical

analyses, which are critical to product safety, legality and quality, carried out and their results recorded?

4.5.2 Are the analyses relevant for food safety performed by a factory internal laboratory?

4.5.3 Is this an accredited laboratory (ISO 17025)?4.5.4 DOC

Provide a copy of the document that details exactly what analysis / testing is carried out and at what frequency?

4.5.5 DOC

How are the testing procedures validated with the external lab? Please attach a recent comparative report.

4.5.6 Are lab /QC / QA personnel suitably qualified and trained?

4.5.7 Does the factory have a final product release system ? Please describe.

4.5.8 Who is responsible for the positive release?

4.5.9 Does the factory have a system for the management of product complaints?

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5.1.1 Is the filling area segregated from other processing areas?

5.1.2 Does the filling area contain all the necessary facilities to ensure the hygiene standards, appropriate to a filling area, can be provided?

5.1.3 How are packaging materials inspected and stored to ensure they remain undamaged, clean and uncontaminated?

5.1.4 Is there a system of positive pressure in the filling area?5.1.5 DOC

After filling are all containers individually labelled in accordance with appropriate industry and legal requirements? Please provide copy of typical label.

Product Packing, Storage & TransportationProduct Packing

Product Analysis



5/25.2.1 Do the storage conditions of raw materials, semi-processed

and finished products as well as packaging in each case correspond to product requirements (eg refrigeration, protective covers) and are they not detrimental to other products?

5.2.2 Are temperatures of storage rooms recorded when appropriate?

5.2.3 How is it ensured that only "foodstuffs only" vehicles are used for bulk transportation?

5.2.4 How is it ensured that the loading temperature is in accordance with the product specification?

5.2.5 Where appropriate, are temperatures of products maintained & monitored during transportation?

5.2.6 DOC Please provide details of all checks carried out on delivery

vehicles prior to loading.5.2.7 Are copies of cleaning certificates accepted?5.2.8 How are temperature conditions determined and ensured

during transportation?5.2.9 What measures are taken to guard against malicious

contamination during storage and transportation (sabotage)?

5.2.10 Will the products be packed and supplied as prescribed (specification), eg heat-treated pallets?

5.2.11 Is each item in storage clearly identified and is the First In/First Out and/or First Expired/First Out principle applied?

Storage & Transport



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6.1.1 Is there a system to check and verify traceability from the sources of raw materials and packaging through the production process to the shipment of the finished product?

6.1.2 Does this traceability system also work in the other direction, ie from "finished product with the customer" back to "raw material sources"?

6.1.3 Is the traceability ensured when rework of the product is performed or part of the product is produced at another location?

6.1.4 DOC Is the traceability system being documented? Please

provide a flow diagram.6.1.5 How long are the traceability records maintained?

6/26.2.1 Does the company have in place a system and procedure to

allow the identification of common food allergens including additives, processing aids and other sensitive substance presenting and allergen risk? Please attach a copy of the plan.

6.2.2 Are systems & procedures in place to allow the identification of products consisting of GMO's or produced from GMO's including food ingredients but also additives and flavours? Please attach a copy of the plan.

77/1

7.1.1 Does the plant have a procedure for product recall?7.1.2 How often is this recall procedure tested to ensure its

effective operation? On what date was it last tested?7.1.3 DOC

Is there a crisis management team in place to handle any crises that may occur? Please provide a copy of the contact details.

7/27.2.1 How are non-conforming products identified, handled,

disposed and documented?

Control of Non-confirming Products

Control of Non Confirming Products

General Traceability

Allergen Risk & GMO Traceability

General Traceability, Allergen Risk

Product Recall


Reference Document Provided ?1.5 Flow chart1.8 Social accountability statement and policy

2.1.2 Current QM certificates

2.2.5 Current quality policy statement

2.3.2 Management organisation diagram

2.5.1.3 Current HACCP certificate(s)

2.5.3.1 Process flow diagram including indication of all CCP's

2.7 Current internal audit schedule

3.3.10.2 Process water treatment flow diagram

3.9.4 Pest control map

4.2.1 Time temperature data for each product

4.2.3 Evaluation method

4.4.7 Latest calibration records - metal detector

4.5.4 Analysis/test schedule - internal laboratory

4.5.5 Comparative testing report - external laboratory

5.1.5 Copy of typical label

5.2.6 Preloading delivery vehicle check list

6.1.4 Traceability flow diagram

7.1.3 Contact details - crisis management team

1. Version; August 8, 2008

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sgf-gmp self assessment questionnaire en

Documents

self assessment questionnaire1

standard questionnaire

fruit juice chain

fruit juice industrysgfgmp

food chain

asked questions

fruit juice industryphone

relevant questions