B.V BZ ZAANDAM

Transcription

1 . QA BROCHURE Buteressence B.V. Rechte Tocht BZ ZAANDAM The Netherlands Phone: +31(0) info@buteressence.com Internet:

2 TABLE OF CONTENTS PAGE Table of contents 2 Welcome 3 Quality policy: 1. Contract control 4 2. Development control 4 3. Quality registration, document and data management 4 4. Purchase and supplier assessment 4 5. Product identification and traceability 4 6. Process control 4 7. Sales and complaint procedure 5 8. Testing and release 5 9. Control of testing and measurement resources Control of deviations, corrective and preventive actions Storage and delivery Audits Training and qualification Verification, evaluation and management assessment Cleaning and maintenance Pest control Controlling absence of foreign bodies Safety Flavourings, colourings, food- and feed safety Other frequently asked questions 8-9 Version: '18 Page 2 of 9

3 Welcome Buteressence is a company that focuses on the development, production and sales of flavourings and colourings for the food and feed industry. For these operations, Buteressence has a state-ofthe-art laboratory, a production department, a commercial department and an independent quality service. Buteressence strives to respond to specific customer needs and contributes in the design and development stage in order to deliver/offer the right flavouring and/or colouring solution at the end. The independent quality service department verifies that the quality system is in compliance with: a. the activities as they are effectively implemented (a.o. internal audits) b. the requirements of ISO 9001, FSSC and GMP+ c. the requirements of Halal, Risk Plaza and RSPO at the product level d. the Health and Safety Act and safe labour conditions e. ethical act with respect to stakeholders and environment Current certificates can be downloaded from our website. We are pleased to present you this brochure on the Buteressence Quality Management System and we hope that it will answer the most important questions you might have. Should you need any further information, we kindly ask you to contact us. Buteressence Version: '18 Page 3 of 9

4 Quality policy: Our organisation s quality policy is based on process control and food safety, commitment within the organisation, predictability, service and flexibility. Following points have been highlighted to inform you on our working procedures: 1. Contract control All contracts that influence quality in terms of sales and/or purchase are registered according to the agreed requirements and authorised by qualified people. Contracts need internal control before they are officially accepted. The order department enters orders into the system. 2. Development control All phases and evaluations are registered; quality references, testing protocols, technical information and formulations of a flavour under development are drawn up and checked. Preparations of relevant analytical and safety information, as well as the allocation of a packaging type, are part of the final phase of a development. All new developments are compared to existing product groups and/or processes. If it is not possible to categorise the new development in these groups/processes, a new safety analysis will be set up for this development. When using a new raw material, we also carry out a hazard analysis and register the results. 3. Quality registration, document and data management The management of Buteressence documents and data is recorded in a set procedure. Documents and data mean: quality registrations, procedures, instructions, forms, legislation and staff qualifications. The management of the documents as part of the quality handbook is the responsibility of the quality assurance department. 4. Purchase and supplier assessment The specifications of raw materials are established by the laboratory. Purchase is permitted when combination of supplier & raw materials is approved. Supplier assessment takes place approximately twice a year according to pre-defined standards and procedures. The tools used for the assessment are a supplier questionnaire and the registered deviations. The non-approved suppliers are registered on a separate list. 5. Product identification and traceability After release, all raw materials, semi-finished products and finished products are identified on the label. The product name, article number and the batch number form a unique code that guarantees the ability to track the raw materials supplier (one step back) and the customer (one step forward) so when needed, a recall procedure can be carried out in time. The recall procedure is tested on an annual basis. 6. Process control The laboratory determines the method of preparation and process conditions. This information is entered into an automated system (see also development control). Products are prepared based on the method of preparation. The method of preparation also states the relevant process data, including safety instructions. Instructions are included in the quality manual. Version: '18 Page 4 of 9

5 7. Sales and complaint procedure The actual sale of products depends on an agreement between Buteressence and the customer on price, quality, planning and terms of delivery. The complaints procedure is coordinated by the Director of sales. Following a first inventory, the customer is informed within 1 working day on the continuation of the process. The objective is to help the customer in the most optimal way. All complaints are registered; they are evaluated periodically by the quality assurance- and sales department. 8. Testing and release Before release (with a specification of the shelf life), each product and each raw material is checked according to a defined testing method. Of each raw material and order we keep a reference which is available for at least 1 year. In addition to an administrative, organoleptic, analytical, microbiological and hygienic check could be carried out. The laboratory has calibrated equipment to carry out these tests, such as GC-FID and GC-MS, as well as a spectrophotometer, ph meters, density meters etc. 9. Control of measurement resources All measurement resources used for quality measurements are subject to the quality system s calibration regime. The quality service department commissions calibration by authorised suppliers. By interim internal and/or external controls we keep the reliability of the measurement at the required level. 10. Control of deviations and corrective actions From any deviation, not only raw material or product-related, a record is kept. Products and raw materials that deviate from the quality requirements are immediately blocked and no longer made available for production. In the case of deviations a structural solution will be implemented. If necessary, an improvement chain is installed where the manager of the relevant department will monitor the progress of the improvement. Corrective measures that lead to modifications in the quality system are the responsibility of the quality service department and according to the applicable procedures. 11. Storage and delivery Storage of raw materials and products takes places according to environment and quality requirements. The products are transported following the ADR and defined transport conditions. Depending on the quality requirements and shelf life of the product, the laboratory determines the storage and transport conditions. The transporters are periodically audited by the quality service department. 12. Audits The entire quality system is annually checked by the quality services according to an established procedure; in addition, our system is also audited each year by external authorities. Irregularities are solved using the corrective action procedure. 13. Training and qualification Each staff member is trained based on a work introduction plan. The employee can only operate independently when they have been qualified by the head of the department. Each year, management will define a training plan. Version: '18 Page 5 of 9

6 14. Verification, evaluation and management assessment Each year, there is an extensive management assessment. The evaluation of the complete quality system is part of the general management review with extensive attention to the food-/feed safety performance over the previous year. Verification of new procedures and work instructions take place before intermediate implementation and is carried out by the management and the head of QA. The verification of measurement resources is carried out before they are put to use. The results of the verification will be processed by the quality service department. 15. Cleaning and maintenance All production and storage areas are cleaned by production staff according to defined instructions which are set up under supervision of the HACCP team, laboratory and the quality service department. Production equipment is cleaned after each production run. Every cleaning is registered. The Buteressence laboratory carries out hygiene checks (a.o. swabs and Petrifilm) and the quality service department carries out the visual hygiene checks on a monthly basis. The Buteressence freestanding building was build in 1997 and is surrounded by a fence. The building has two floors and can only be entered with permission. On the ground floor the office, canteen, dressing rooms, and production with in- and outgoing expeditions are situated. On the first floor the laboratory and the packaging/storage space are situated. The interior is according to the GMP requirements for the food and feed industry and the environments requirements and health and safety legislation. For the maintenance of the building, both inside and outside, of the office equipment, production and laboratory, we use maintenance lists. Performed maintenance and repairs are recorded in the logbooks of the respective equipment. 16. Pest control SGS Sanitec carries out stringent pest control (monthly) and the results are registered. In addition, internal checks are carried out. Any vermin signalled leads to calling in our external pest controller. 17. Controlling absence of foreign bodies Various measures are in place to ensure the absence of foreign bodies on the work floor, including: work instructions, rules for visitors, cleaning procedures and packaging instructions. Raw materials level: Only raw materials that meet the defined requirements are released. Buteressence uses several control measures depending on the risk assessment, including specifications, analyses and reports of internal or external analyses. Furthermore, all raw materials need to comply with the General Food Law (Regulation (EC) 178/2002). All raw materials are inspected in batches, according to a specific inspection protocol, which has been developed partly on the basis of the above-mentioned risk assessment. See also section 4 and section 19. Version: '18 Page 6 of 9

7 Product level: Physical hazard: Prior to delivery, flavours and colours are checked on the presence of a possible physical hazard. Products are sieved during the final packaging. When a physical contamination is found in the product, the product will be blocked. The Buteressence working procedures are according to the GMP regulations. Glass policy: Due to the advantages of the chemical properties of glass Buteressence uses glass in the production area. Before starting production, all glass bottles that will be used are checked on possible cracks and/or damages. When broken glass is detected the quality service and laboratory department are called in. No risk will be taken on the food and feed safety requirements. 18. Safety General and product-specific safety measures have been formulated and implemented for all staff; both aspects are integrated in our quality system. Relevant safety information is available to customers. All products are dispatched according to government requirements. 19. Flavourings, colourings, food- and feed safety Buteressence flavourings and colourings are especially developed for the food and feed industry. The flavourings and colourings comply with the current EU regulations. Buteressence products are delivered to the customer in sealed (outer) packaging. This seal guarantees that no contamination can take place during transport. As part of the offer procedure the product specification (including GMO), allergen list and safety data sheet are sent to the customer. The final consumer group is not known to Buteressence, the product information is delivered as business to business information. Customers are offered the opportunity to join our digital information, allowing them to have current information about their purchased products at all times. Chemical hazards: In the case of normal use according to the specified dosage, there will be no danger for public health. The dosage guidelines for flavourings are determined based on the intended effect in neutral consumer products. The flavourings have a self-limiting maximum dosage, which means if the dosage is too high, the product will no longer have a pleasant flavour/taste. Also a maximum dosage is possible from the legislation (a.o. Regulation (EC) No 1334/2008 and amendments). The maximum dosage of colourings is defined in Commission Regulation (EC) No 1129/2011 and amendments. Before delivery, flavourings and colourings are analysed. Organoleptic tests, Gas chromatic- Flame Ionisation detection (GC-FID) and Gas Chromatic Mass Spectrometer (GC-MS) are used. The product is released when it passes the analyses according to the specifications. Analyses are made by means of organoleptic checks, Gas Chromatograph Flame Ionization Detector (GC-FID), Gas Chromatograph Mass Spectrometer (GC-MS) and other calibrated equipment. Version: '18 Page 7 of 9

8 Allergens: The consumption of small quantities of allergens can cause allergic reactions to consumers sensitive to specific allergens. The risks of the presence of unwanted allergens have been assessed. The products of Buteressence B.V. are sold to industrial clients, who have access to all information on allergens. Allergen procedure: 1) Changes in regulation on allergens are carefully kept up-to-date; 2) (New) ingredients are labelled as allergen or non allergen. During the whole production process this information stays linked to the ingredient; 3) All products have an allergen list which is available to the customer; 4) Exclusion of allergens contamination in products is secured by the PRP (Pre Requisite Programme) which includes the cleaning procedure; 5) The finished product can be analysed by GC (see chemical hazards); Microbiological hazards: In general our product is not a good breeding ground for micro-organisms as substances with antimicrobial properties are often being used. The products are classified through the work instruction Microbiological testing according to the risk and randomly analyzed by an accredited laboratory. In case the internal standards are exceeded an pathogen research takes place. 20. Other frequently asked questions What is the country of origin? The country of origin is generally the Netherlands, as it is produced at our production site in Zaandam. The origin can be found on the certificate of conformity which is provided with each delivery. Information about the origin for used raw materials is considered an internal matter. Are certificates of analysis available? Buteressence provides certificates of conformity with each delivery, which state that the listed products meet the food-/feed safety requirements of our quality system. In addition Buteressence also declares in the conformity certificate that listed products have been inspected and meet the predefined quality requirements. Since the dosage of flavours / colours are very low and are generally specified in permillages, the effects on the final analysis of the consumer product are negligible. Is the used packaging material suitable for the application? Our products are supplied in packaging that is suitable and complies with the applicable regulations. We have relevant statements of our packaging suppliers for internal use. Our quality service governs the validity of these statements. Version: '18 Page 8 of 9

9 Why the choice for FSSC 22000? Buteressence works according to certified quality systems. Initially, ISO 9001 combined with HACCP. The choice for HACCP was based on the fact that this was the most widely introduced food safety system in the Netherlands. In 2007 Buteressence switched from HACCP to ISO This system is based on HACCP, but with a broader international recognition. However, we received more and more demands from our customers for a certification according to one recognized by the GFSI standard and in 2013 we made the choice for FSSC 22000, a standard building on the existing ISO system. With the FSSC certification we meet - as well as the many companies with a BRC or IFS certificate - the stringent requirements of the GFSI for a good food safety system. FSSC 22000, combined with an ISO 9001 certification for our quality management system, gives a complete overview of the quality assurance of both the product and the production process. This is representative for the way leading suppliers in the flavour industry are managing their food safety and quality issues. Statements; - BRC and IFS Food are food safety systems that have their origins in Great Britain and Germany respectively. BRC was developed by the trade association of retailers and IFS by the trade association of distributors of food products. - GFSI stands for Global Food Safety Initiative and its mission is to ensure continuous improvement of food safety systems, in order to ensure confidence in the delivery of safe food to consumers worldwide. It is a non-profit foundation managed by The Consumer Goods Forum ( CGF ), a global industry network from retailers, manufacturers, service providers and other parties concerned, and reflects the diversity of the industry in geography as well as size and product category. Version: '18 Page 9 of 9