Audit Report. 1.Audit Summary. 2. Results. 3.Company Details. Global Standard for Food Safety Issue 6: July 2011.

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1 Audit Report Global Standard for Food Safety Issue 6: July Audit Summary Company name Valley Processing BRC Site Code Site name Scope of audit Exclusions from scope Valley Processing The receiving of fresh fruit and processing it through washing, grinding, filtration and pasteurization for single strength juice also taking and evaporating to make concentrates of grape, apple, pear which are shipped out in insulated tankers or drums. Nothing Audit Finish Date Results Audit result Certificated Audit grade B Audit type Announced Audit frequency 12 months Re-audit due date Previous audit grade B Previous audit date Number of Non-Conformities Fundamental 0 Critical 0 Major 0 Minor 15 3.Company Details Address Valley Processing 108 East Blaine Ave Sunnyside, WA Country United States Telephone ext 12 Commercial representative Name Mary Ann Bliesner maryann@valleyprocessing.com Page 1 of 60

2 3.Company Details Technical representative Name Penny Babalya 4.Company Profile Plant size (meters square) No. of employees 70 No. of HACCP plans 5 Subcontracted processes No Other certificates held Kosher Regions exported to North America Asia Major changes since last BRC audit Flooring in Tank Room 1 was replaced, rebuilt gutters and drains, Company Description Valley Processing is located in a semi-industrial area. It was built in 1950 and has two production lines. It has four building of which two are production, one is packing, and one is a freezer. The Facility is 125,000 square feet. It is privately owned. It processes raw fruit into juice, juice concentrate, purees and essences. The fruits are apple, grapes, pears, cranberries, cherries, and raspberries, 5.Product Characteristics Product categories 07 - Dairy, liquid egg Finished product safety rationale The finished product has been pasteurized High care No High risk No Allergens handled on site None Product claims made e.g. IP, organic Kosher and Organic Product recalls in last 12 Months No Products in production at the time of the audit Grape juice and apple juice Page 2 of 60

3 6.Audit Duration Details On-site duration 24 man hours Duration of production facility inspection 10 man hours Reasons for deviation from typical or expected audit duration Next audit type selected none Announced Audit Duration per day Audit Days Audit Dates Audit Start Time Audit Finish Time :00 15: :00 15: :00 15:00 7.Key Personnel Auditor Number Auditor Names and roles Richard LaCalamito Present at audit Note: the most senior operations manager on site should be listed first and be present at both opening & closing meetings (ref: clause 1.1.9) Name / Job Title Mary Ann Bliesner- Owner and President Charlie Meyers- Plant Manager Penny Babalya- Quality Systems Manager (QSM) Opening Meeting Site Inspection Procedure Review x x x Closing Meeting x x x x x Page 3 of 60

4 Non-Conformity Summary Sheet Critical or Major Non Conformities Against Fundamental Requirements No. Requirement ref. Details of non-conformity Critical or Major? Anticipated re-audit date Critical No. Requirement ref. Details of non-conformity Anticipated re-audit date Major No. Requirement Root cause analysis and proposed Details of non-conformity Corrective action taken ref. action plan Evidence provided document, photograph, visit/other Date reviewed Reviewed by Page 4 of 60

5 Minor No. 1 Requirement Root cause analysis and proposed Details of non-conformity Corrective action taken ref. action plan Need to have more details on methods to prevent contamination of organic product written into the HACCP program. Expanded HACCP System to include a new section on Organic Program and a new section on Preventative Maintenance section. Reissued document per REV#11. Had organic mentioned in our HACCP System but considered organic managed as a separate programs certified and audited for compliance by the WA. State Dept of Ag. not specifically by the FDA.. Evidence provided document, photograph, visit/other The facility amended HACCP System REV#11 which was revised on Oct. 19, 2012 Date reviewed November 12, 2012 Reviewed by Richard LaCalamito The monthly audits need to have the corrective action, time frame and who has the responsibility written into the internal audits. When the Food Safety/ HACCP Committee reviews the October 2012 plant audits, they will assign the responsibility and timeline for all corrective actions. These responsibility and time assignments will be published in the subsequent plant audit report. Always listed completed corrective actions but refrained from projecting a fix date/individual because I wanted to know when it was done not projected to be done. Will add a projected date from now on. The facility amended Internal Audit Policy DOC# REV#6 which as revised on November 12, 2012 Richard LaCalamito Page 5 of 60

6 Minor The wall NE corner of filter room needs patched. Plant #1:Filter Room The wall surface was damaged and is now Repaired. Damage was noted in Plant #1 monthly audit but repair had not been done yet. There is photo evidence of this repair. November 12, 2012 Richard LaCalamito The floor needs patched in the cold room near the one support column Plant #1 barrel room/coldroom floor has been repaired. Damaged area was missed during monthly plant audit and will be repaired now. There is photo evidence of this repair. November 12, 2012 Richard LaCalamito There is no designated walk way in some sections of building number 1. Walkways have been repainted along the main hallway, filter room,decanter room and west end of Plant #1 Plant #1 first floor had extensive gutter and drain repairs so floors were torn out which destroyed the walkway designations. There is photo evidence of this repair. There are painted walkways in each room. November 12, 2012 Richard LaCalamito There are some sections of the ceiling in the cooler of building 1 which need to be repaired. Plant #1 barrel room/coldroom ceiling has been repaired. Barrelroom/coldroom ceiling repair was missed previously but is now fixed. There is photo evidence of this repair.. November 12, 2012 Richard LaCalamito Page 6 of 60

7 Minor The U-7 tank has duct tape closing a hole. The duct tape is also ripped through with a 1/4" gap. Plant #1 the top of tank U7 has been repaired so a permanent repair is now in place(no duct tape). Tank is not used that often so the temporary repair missed being upgraded to a permanent repair. The facility has a new Maintenance Repair log and the photo evidence of this repair. November 12, 2012 Richard LaCalamito The upper deck in the tank room needs swept The upper deck area has been cleaned. Depending on product run, this area can sit idle at times and was missed during last clean up. photo proof of clean-up. November 12, 2012 Richard LaCalamito The sink located in building 1 needs to be hands free upon entrance A new hands-free faucet has been installed in the Plant #1 grape lab. Faucet leaked but lacked a hands-free design. The faucet was leaking and needed replacement. It has been replaced with a hands-free faucet. photo evidence of the new handsfree faucet in the grape lab November 12, 2012 Richard LaCalamito The metal control program needs to have a sign out for lost and damaged knives. Have amended our Knife Handling Training Sheet to include instructions if knife is broken or lost, employee Did not previously document damaged or lost knives. Issue new sign off DOC# REV#0 The facility has put in the proper Use of Sharp Instruments/Knives November 12, 2012 Richard LaCalamito Page 7 of 60

8 Minor must report it to their supervisor. Supervisors now have a new sign off sheet that must be completed for any lost or broken knife published and now all shift supervisors have this sheet to document broken or lost utility knives on their shift. was amended DOC# A REV#5 to include a new sign off sheet for lost or broken knife DOC# REV#0 published on There were clamps on the ground and not hung up in building number 2. GMP noncompliance was addressed by amending GMP training sheet to specifically state no parts on floors and then employee was counseled Using GMP Training DOC#033104A REV#19 conducted Employee was lax and failed to obey proper GMP when handling food equipment parts so he has been counselled on by the Quality Systems Manager and has signed off on DOC#033104A REV#19 published on GMP Training/ added item #14 DOC#033104A REV#19. Retraining done with specific employee signed training sheet attached. November 12, 2012 Richard LaCalamito There was product stored next to the walls in finished product ware house. Product is being moved away from the walls to allow for visual inspection behind To maximize storage employees backed pallets too close to walls but are photo evidence of new perimeter in that cold room. November 12, 2012 Richard LaCalamito Page 8 of 60

9 Minor Product on pallets moving pallets out now The maintenance department needs a written procedure and check off list after work is completed. The Maintenance Dept. has published a Temporary Maintenance Repair Log to document when they are upgraded to permanent repairs. Had not established a formal checklist for documented the upgrade of temporary repairs to permanent repairs. See new Maintenance Log with the tank U7 repair work documented now. Document proof of both the new maintenance log and the repair itself November 12, 2012 Richard LaCalamito The ingredients used in processing need a FIFO Will attach copies of the receiving sheet for incoming processing & filtering aids and packaging and the new training sheet to facilitate current FIFO Program DOC#053007A REV# Have always maintained FIFO use of raw materials and JIT inventory program but will add copy of the dated receiving sheet at front of row to facilitate FIFO rotation. New vendor Program Doc#053007A and training sheets for 2 personnel who unload trucks DOC#053007A REV# November 12, 2012 Richard LaCalamito There was a knife on a ledge by a tank in building number 2 which had not been tethered. All knives are now tethered so they are protected from falling into product, tanks or equipment. Maintenance had missed adding tethers at some knife locations. I have added a tether statement to the Proper Use of Sharp Instruments/Utility Knives photo proof of knife tethered at Each tank and see amended Proper Use of November 12, 2012 Richard LaCalamito Page 9 of 60

10 Minor DOC#091010A REV#5 which was amended on Sharp Instruments Utility Knives DOC#091010A REV# Page 10 of 60

11 Detailed Audit Report 1. Senior Management Commitment 1.1 Senior management commitment and continual improvement The President of the company signed a Documented Quality Statement. This is located at the entrance to the facility for all to read. It was dated This mission statement states that the company will produce the highest quality and safest product. This statement is hung in the entrance to the plant. There are weekly meeting were the company targets are reviewed. The targets are customer complaints. For Customer complaints: the expected complaints level is zero for products produced the actual is 4 complaints year to date. The objectives are communicated to senior staff monthly. The plant manager was the highest operations person in attendance at both the opening and closing meeting. All the non-conformances from last year have been corrected these were as follows: The HACCP sheet has a mention on the master sheet of shipping inspection as a CCP. It is also mentioned in the HA sheet but is not listed as a CCP. There are records of it being inspected as a CCP. There were some papers regarding inspection of seals on drums, which were signed by the operator but were not verified by an authorized person. There was a large amount of conforming items on the internal audit mostly non-conforming on the internal audits. The non-food chemicals and food grade chemicals are stored in the same locked cabinet in Parts Room number 1. There are no signs up to inform persons to wash hands before returning to work after smoking. There were 14 holes in the wall going into the Far West Room. There was an opening under a garage door in plant #2. This was a different door from last year. The cleaning equipment (brooms, mops, etc.) were not hung up but were on the floor standing up. The lights for the forklift truck were not on the register. The pasteurizer operator knew what he was to do, but when asked about what a CCP was (which he conducted) and HACCP was not able to answer the question. The sight plan does not show the routes of travel for the employees. There are no designated walkways. There is no sign off sheet of employees taking plasters. Requirement No REQUIREMENT Conforms FUNDAMENTAL The company s senior management shall demonstrate they are fully committed to the implementation of the requirements of the Global Standard for Food Safety and to processes which facilitate continual improvement of food safety and quality management The company shall have a documented policy which states the company s intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be: signed by the person with overall responsibility for the site communicated to all staff The company s senior management shall ensure that clear objectives are Page 11 of 60

12 defined to maintain and improve the safety, legality and quality of products manufactured, in accordance with the quality policy and this Standard. These objectives shall be: documented and include targets or clear measures of success clearly communicated to relevant staff monitored and results reported at least quarterly to site senior management Management review meetings attended by the site s senior management shall be undertaken at appropriate planned intervals, annually as a minimum, to review the site performance against the Standard and objectives set in The review process shall include the evaluation of: previous management review action plans and time frames results of internal, second party and/or third party audits customer complaints and results of any customer performance reviews incidents, corrective actions, out of specification results and nonconforming materials review of the management of the HACCP system resource requirements. Records of the meeting shall be documented and used to revise the objectives. The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff, and actions implemented within agreed time scale The company shall have a demonstrable meeting program which enables food safety, legality and quality issues to be brought to the attention of senior management at least monthly and allows for the resolution of issues requiring immediate action The company s senior management shall provide the human and financial resources required to produce food safely in compliance with the requirements of this Standard and for the implementation of the HACCPbased food safety plan The company s senior management shall have a system in place to ensure that the company is kept informed of scientific and technical developments, industry codes of practice and all relevant legislation applicable in the country of raw material supply, production and, where known, the country where the product will be sold The company shall have a genuine, original hard copy or electronic version of the current Standard available Where the company is certificated to the Standard it shall ensure that announced recertification audits occur on or before the audit due date indicated on the certificate The most senior production or operations manager on site shall attend the opening and closing meetings of the audit for Global Standard for Food Page 12 of 60

13 Safety certification. Relevant departmental managers or their deputies shall be available as required during the audit process The company s senior management shall ensure that the root causes of non-conformities identified at the previous audit against the Standard have been effectively addressed to prevent recurrence. 1.2 Organizational structure, responsibilities and management authority An organization chart was last updated in January 5, There is a clear description of who takes over in the absence of key individuals. There are job descriptions for all personnel in the facility. The job description for key management and line workers were reviewed and were adequate. The company shall have a clear organizational structure and lines of communication to enable effective management of product safety, legality and quality The company shall have an organization chart demonstrating the management structure of the company. The responsibilities for the management of activities which ensure food safety, legality and quality shall be clearly allocated and understood by the managers responsible. It shall be clearly documented who deputizes in the absence of the responsible person The company s senior management shall ensure that all employees are aware of their responsibilities. Where documented work instructions exist for activities undertaken, the relevant employees shall have access to these and be able to demonstrate that work is carried out in accordance with the instruction. Page 13 of 60

14 2 The Food Safety Plan HACCP FUNDAMENTAL Statement of Intent The company shall have a fully implemented and effective food safety plan based on Codex Alimentarius HACCP principles. The company s HACCP plan is systematic, comprehensive, thorough and fully implemented. The HACCP is based on the Codex Alimentarius principles and reference has been made to relevant legislation, guidelines and codes of practice. There is a multi-disciplinary food safety team that includes. Quality Systems Manager, President, Vice President of Operations, Plant Manager, and Maintenance Supervisor. The following individuals have been trained in HACCP and their date of completion of the course. The QSM (Quality Systems Manager) received training in 1994 from the Washington State University for three days. The QSM had a refresher course in May The other members of the team were trained in 2012 by the QSM. A full description of the product produced (applets, grapes, cherries, berries, and other fruit) is present in the HACCP manual as part of the product description and intended use. There is a full description of the process. A full detailed hazard analysis has been completed to identify hazards, which need to be prevented, eliminated or reduced to acceptable levels. This is all defined in the Hazard Analysis Report. This includes the likely hood of occurrence, severity, presence of toxins (patulin in apples), contamination and adulteration. There are five HACCP plans. 1. All apple and pear puree concentrates have the following CCP s, pasteurization at 166 o F for 15 seconds and Patulin testing. 2. All strengh purees have CCP s of pasturization at 166 o F for 15 seconds and the magnets. 3. Apple and Pear Juice have the following CCP s, pasteurization at 166 o F for 15 secondsand Patulin testing 4. Grape juice concentrate have pasteurization at 166 o F for 15 seconds. 5. All other juices have pasteurization at 166 o F for 15 seconds. All products must be signed off by the QS Manager/Plant Manager before release.. The validation and of the CCPs was done on all products on May 29 th and August 15 th The flow diagrams have been reviewed and updated by the team on May 29 th and August 15 th The records on all CCPs were reviewed for August 1-7, 2012 and were complete and acceptable. The product is packed in bulk tankers, 55 gallon drums, and 4/5 gallon plastic containers. It is either frozen or refrigerated. The shelf life of frozen is 3 years and non-frozen is 2 years. An acceptable Hazard Analysis was reviewed and found acceptable. The pre-requisite programs were reviewed and found acceptable. There was one minor non-conformance. There needs to be more details on methods to prevent contamination of organic product written into the HACCP program. 2.1 The HACCP food safety team Codex Alimentarius Step 1 Page 14 of 60

15 2.1.1 The HACCP plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for quality/technical, production operations, engineering and other relevant functions. The team leader shall have an in-depth knowledge of HACCP and be able to demonstrate competence and experience. The team members shall have specific knowledge of HACCP and relevant knowledge of product, process and associated hazards. In the event of the company not having appropriate in-house knowledge, external expertise may be used, but day-to-day management of the food safety system shall remain the responsibility of the company. 2.2 Prerequisite programs The company shall establish and maintain environmental and operational programs necessary to create an environment suitable to produce safe and legal food products (prerequisite programs). As a guide these may include the following, although this is not an exhaustive list: cleaning and sanitizing pest control maintenance programs for equipment and buildings personal hygiene requirements staff training purchasing transportation arrangements processes to prevent cross-contamination allergen controls. No The control measures and monitoring procedures for the prerequisite programs must be clearly documented and shall be included within the development and reviews of the HACCP 2.3 Describe the product Codex Alimentarius Step The scope of each HACCP plan, including the products and processes covered, shall be defined. For each product or group of products a full description shall be developed, which includes all relevant information on food safety. As a guide, this may include the following, although this is not an exhaustive list: composition, e.g. raw materials, ingredients, allergens, recipe origin of ingredients physical or chemical properties that impact food safety, e.g. ph, aw treatment and processing, e.g. cooking, cooling packaging system, e.g. modified atmosphere, vacuum storage and distribution conditions, e.g. chilled, ambient target safe shelf life under prescribed storage and usage conditions instructions for use, and potential for known customer misuse, e.g. storage, preparation All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. The company will ensure that Page 15 of 60

16 the HACCP plan is based on this may include the following, although this is not an exhaustive list: the latest scientific literature historical and known hazards associated with specific food products relevant codes of practice recognized guidelines food safety legislation relevant for the production and sale of products customer requirements 2.4 Identify intended use Codex Alimentarius Step The intended use of the product by the customer shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, and allergy sufferers). 2.5 Construct a process flow diagram Codex Alimentarius Step A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list: plan of premises and equipment layout raw materials including introduction of utilities and other contact materials, e.g. water, packaging sequence and interaction of all process steps outsourced processes and subcontracted work process parameters potential for process delay rework and recycling low/high-care/high-risk area segregation finished products, intermediate/semi-processed products, by-products and waste. 2.6 Verify flow diagram Codex Alimentarius Step The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge at least annually. Daily and seasonal variations shall be considered and evaluated. Records of verified flow diagrams shall be maintained. 2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards Codex Alimentarius Step 6, Principle The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities. This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and allergen risks (refer to clause 5.2). It shall also take account of the preceding and following steps in the process chain The HACCP food safety team shall conduct a hazard analysis to identify hazards Page 16 of 60

17 which need to be prevented, eliminated or reduced to acceptable levels. Consideration shall be given to the following: likely occurrence of hazard severity of the effects on consumer safety vulnerability of those exposed survival and multiplication of micro-organisms of specific concern to the product presence or production of toxins, chemicals or foreign bodies contamination of raw materials, intermediate/semi-processed product, or finished product. Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Where the control is achieved through existing prerequisite programs, this shall be stated and the adequacy of the program to control the hazard validated. Consideration may be given to using more than one control measure. 2.8 Determine the critical control points (CCP) Codex Alimentarius Step 7, Principle For each hazard that requires control, control points shall be reviewed to identify those that are critical. This requires a logical approach and may be facilitated by use of a decision tree. CCPs shall be those control points which are required in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level. If a hazard is identified at a step where control is necessary for safety but the control does not exist, the product or process shall be modified at that step, or at an earlier or later step, to provide a control measure. 2.9 Establish critical limits for each CCP Codex Alimentarius Step 8, Principle For each CCP, the appropriate critical limits shall be defined in order to identify clearly whether the process is in or out of control. Critical limits shall be: measurable wherever possible, e.g. time, temperature, ph supported by clear guidance or examples where measures are subjective, e.g. photographs The HACCP food safety team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level Establish a monitoring system for each CCP Codex Alimentarius Step 9, Principle A monitoring procedure shall be established for each CCP to ensure compliance with critical limits. The monitoring system shall be able to detect loss of control of CCPs and wherever possible provide information in time for corrective action to be taken. As a guide, consideration may be given to the following, although this is not an exhaustive list: Page 17 of 60

18 online measurement offline measurement continuous measurement, e.g. thermographs, ph meters etc. where discontinuous measurement is used, the system shall ensure that the sample taken is representative of the batch of product Records associated with the monitoring of each CCP shall include the date, time and result of measurement and shall be signed by the person responsible for the monitoring and verified, as appropriate, by an authorized person. Where records are in electronic form there shall be evidence that records have been checked and verified Establish a corrective action plan Codex Alimentarius Step 10, Principle The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure to meet a control limit, or when monitored results indicate a trend towards loss of control. This shall include the action to be taken by nominated personnel with regard to any products that have been manufactured during the period when the process was out of control Establish verification procedures Codex Alimentarius Step 11, Principle Procedures of verification shall be established to confirm that the HACCP plan, including controls managed by prerequisite programs, are effective. Examples of verification activities include: internal audits review of records where acceptable limits have been exceeded review of complaints by enforcement authorities or customers review of incidents of product withdrawal or recall. Results of verification shall be recorded and communicated to the HACCP food safety team HACCP documentation and record keeping Codex Alimentarius Step 12, Principle Documentation and record keeping shall be sufficient to enable the company to verify that the HACCP controls, including controls managed by prerequisite programs, are in place and maintained Review the HACCP plan The HACCP food safety team shall review the HACCP plan and prerequisite programs at least annually and prior to any changes which may affect product safety. As a guide, these may include the following, although this is not an exhaustive list: change in raw materials or supplier of raw materials change in ingredients/recipe change in processing conditions or equipment change in packaging, storage or distribution conditions Page 18 of 60

19 change in consumer use emergence of a new risk, for example adulteration of an ingredient developments in scientific information associated with ingredients, process or product. Appropriate changes resulting from the review shall be incorporated into the HACCP plan and/or prerequisite programs, fully documented and validation recorded. Page 19 of 60

20 3. Food safety and quality management system 3.1 Food safety and quality manual There is an updated Quality Manual available in both a printed and electronic version. This manual is available for all to read in a protected intranet version. The table of contents is broken down into sanitation, CIPs, Policy and Procedures, Certifications, Maps, Formulas, HACCP, etc. The documents in the manual are up to date. It consists of 22 documented policy and procedure. The company s processes and procedures to meet the requirements of this Standard shall be documented to allow consistent application, facilitate training, and support due diligence in the production of a safe product. Choose an item The company s documented procedures, working methods and practices shall be collated in the form of a printed or electronic quality manual The food safety and quality manual shall be fully implemented and the manual or relevant components shall be readily available to key staff All procedures and work instructions shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by appropriate staff. This shall include the use of photographs, diagrams or other pictorial instructions where written communication alone is not sufficient (e.g. there are issues of literacy or foreign language). Choose an item. Choose an item. Choose an item. 3.2 Documentation control The removal of obsolete information is removed as per Document Control Policy Revision 8 dated September 25, The removal of obsolete documents is the responsibility of the QS Manager. The company shall operate an effective document control system to ensure that only the correct versions of documents, including recording forms, are available and in use The company shall have a procedure to manage documents which form part of the food safety and quality system. This shall include: a list of all controlled documents indicating the latest version number the method for the identification and authorization of controlled documents a record of the reason for any changes or amendments to documents the system for the replacement of existing documents when these are updated. 3.3 Record completion and maintenance There was documentation available to show that food products meet the Food Safety requirements. This included, the COAs, laboratory testing records, and process control records. The records are kept for a period of 5 years. The company shall maintain genuine records to demonstrate the effective control of product safety, legality and quality. Choose an item. Page 20 of 60

21 3.3.1 Records shall be legible, retained in good condition and retrievable. Any alterations to records shall be authorized and justification for alteration shall be recorded. Where records are in electronic form these shall be suitably backed up to prevent loss Records shall be retained for a defined period with consideration given to any legal or customer requirements and to the shelf life of the product. This shall take into account, where it is specified on the label, the possibility that shelf life may be extended by the consumer (e.g. by freezing). As a minimum, records shall be retained for the shelf life of the product plus 12 months. Choose an item. Choose an item. 3.4 Internal audit Internal audits are conducted on a monthly basis. The HACCP, GMP and Food Safety audits for July and August were reviewed and all showed corrective action taken and were signed off when the corrective action was completed. All corrective actions had been completed in the designated time frames. All auditors (HACCP team member) in the facility were given documented training by the QS Manager. There was one minor non-conformance. The monthly audits need to have the corrective action, time frame and who has the responsibility written into the internal audits. FUNDAMENTAL Statement of Intent The company shall be able to demonstrate it verifies the effective application of the food safety plan and the implementation of the requirements of the Global Standard for Food Safety There shall be a planned program of internal audits with a scope which covers the implementation of the HACCP program, prerequisite programs and procedures implemented to achieve this Standard. The scope and frequency of the audits shall be established in relation to the risks associated with the activity and previous audit performance; all activities shall be covered at least annually Internal audits shall be carried out by appropriately trained competent auditors, who are independent from the audited department The internal audit program shall be fully implemented. Internal audit reports shall identify conformity as well as non-conformity and the results shall be reported to the personnel responsible for the activity audited. Corrective actions and timescales for their implementation shall be agreed and completion of the actions verified. No In addition to the internal audit program there shall be a program of documented inspections to ensure that the factory environment and processing equipment is maintained in a suitable condition for food production. These inspections shall include: hygiene inspections to assess cleaning and housekeeping performance fabrication inspections to identify risks to the product from the building or equipment The frequency of these inspections shall be based on risk but will be no less than once per month in open product areas. Page 21 of 60

22 3.5 Supplier and raw material approval and performance monitoring Management of suppliers of raw materials and packaging There are documented policies, which all suppliers must meet. There are written in Document revision 11 dated October 11, 2012 for fruit versus non-fruit products (enzymes, filter aids) and Revision 3 dated May 4, 2011 for food products. This contains all letters of guarantee, the product information. The Hazard Analysis program has a check-off list of all ingredient requirements for allergens, foreign body, micro, and chemical contaminations. All raw materials, including packaging must have COAs attached with them upon delivery. The receiving records of ingredients receipt were reviewed and found acceptable. There are formal agreements with suppliers. The Kosher certificate expires on December 31, The following suppliers letters of guarantee, COAs and specifications were reviewed and found acceptable. These were diatomaceous earth, 5 gallon drums, pectonase, amylase, charcoal, and organic grapes. All ingredients are inspected upon receipt and COAs must accompany them. The dry ingredient trucks are all inspected upon arrival and a review of the records showed this was in place. There are outside services for pest control, laundry, maintenance contracted out, laboratory testing, and waste management which were all approved and monitored. The company shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials (including packaging) to the safety, legality and quality of the final product are understood and managed The company shall undertake a documented risk assessment of each raw material or group of raw materials to identify potential risks to product safety, legality and quality. This shall take into account the potential for: allergen contamination foreign body risks microbiological contamination chemical contamination. Consideration shall also be given to the significance of a raw material to the quality of the final product. The risk assessment shall form the basis for the raw material acceptance and testing procedure and for the processes adopted for supplier approval and monitoring The company shall have a documented supplier approval and ongoing monitoring procedure to ensure that suppliers are manufacturing products under hygienic conditions, effectively manage risks to raw material quality and safety and are operating effective traceability processes. The approval and monitoring procedure shall be based on one or a combination of: supplier audits third party audits or certification, e.g. to BRC Global Standards supplier questionnaires. Page 22 of 60

23 Where approval is based on questionnaires, these shall be reissued at least every three years and suppliers required to notify the site of any significant changes in the interim The procedures shall define how exceptions are handled (e.g. where raw material suppliers are prescribed by a customer or where products are purchased from agents and direct audit or monitoring has not been undertaken) Raw material and packaging acceptance and monitoring procedures Controls on the acceptance of raw materials shall ensure that raw materials do not compromise the safety, legality or quality of products. Choose an item The company shall have a documented procedure for the acceptance of raw materials and packaging on receipt based upon the risk assessment (3.5.1). Raw material acceptance and its release for use shall be based on one or a combination of: visual inspection on receipt certificates of conformance specific to each consignment certificates of analysis product sampling and testing. Choose an item. A list of raw materials and the requirements to be met for acceptance shall be available. The parameters for acceptance and frequency of testing shall be clearly defined The procedures shall be fully implemented and records maintained to demonstrate the basis for acceptance of each batch of raw materials. Choose an item Management of suppliers of services The documentation to check the pest control is done on a monthly basis, contracted services and maintenance of equipment; laboratory testing is done through proficiency testing. These are documented In the HACCP plan and Vendor approval. There is no contracted cleaning, catering services, and off-site storage. The company shall be able to demonstrate that where services are outsourced, the service is appropriate and any risks presented to food safety have been evaluated to ensure effective controls are in place. Choose an item There shall be a documented procedure for the approval and monitoring of suppliers of services. Such services shall include as appropriate: pest control laundry services contracted cleaning contracted servicing and maintenance of equipment transport and distribution off-site storage of ingredients, packaging or products laboratory testing catering services waste management. Choose an item. Page 23 of 60

24 Contracts or formal agreements shall exist with the suppliers of services which clearly define service expectations and ensure potential food safety risks associated with the service have been addressed. Choose an item Management of outsourced processing There is no outsourced processing. Where any intermediate process steps in the manufacture of a product which is included within the scope of certification is subcontracted to a third party or undertaken at another company site, this shall be managed to ensure this does not compromise the safety, legality or quality of the product The company shall be able to demonstrate that where part of the production process is outsourced and undertaken off site, this has been declared to the brand owner and, where required, approval granted The company shall ensure that subcontractors are approved and monitored by successful completion of either a documented site audit or third-party certification to the BRC Global Standard for Food Safety or other GFSIrecognized Standard (see Glossary) Any outsourced processing operations shall: be undertaken in accordance with established contracts which clearly define any processing requirements and product specification maintain product traceability The company shall establish inspection and test procedures for outsourced product on return, including visual, chemical and/or microbiological testing, dependent on risk assessment. 3.6 Specifications There are specifications for all products, ingredients and finished product. Specifications were checked for diatomaceous earth, 5 gallon drums, pectonase, amylase, charcoal, and organic grapes. There were letters of guarantee and specifications for all products from all the suppliers checked. These showed micro, chemical, and physical standards. All stated meet Federal Pure Food and Drug requirements as dictated in CFR 21. Where non-conformances against standards, specification, and procedures have occurred, the company has a comprehensive system in place to investigate these. There is a hold/release program and corrective action documentation Procedure. The corrective action must be conducted within a reasonable period. Corrective action is to be signed off by the appropriate Manager. The specifications are reviewed on a as needed basis or every three years. Specifications shall exist for raw materials including packaging, finished products and any product or service which could affect the integrity of the finished product Specifications for raw materials and packaging shall be adequate and accurate Page 24 of 60

25 and ensure compliance with relevant safety and legislative requirements. The specifications shall include defined limits for relevant attributes of the material which may affect the quality or safety of the final products (e.g. chemical, microbiological or physical standards) Manufacturing instructions and process specifications shall comply with recipes and quality criteria as detailed in agreed customer specifications Specifications shall be available for all finished products. These shall either be in the agreed format of the customer or, in the case of branded products, include key data to meet legal requirements and assist the customer in the safe usage of the product The company shall seek formal agreement of specifications with relevant parties. Where specifications are not formally agreed then the company shall be able to demonstrate that it has taken steps to ensure formal agreement is in place Specifications shall be reviewed whenever products change (e.g. ingredients, processing method) or at least every three years. The date of review and the approval of any changes shall be recorded. 3.7 Corrective action Corrective actions were reviewed for internal audits, monthly technical meetings, annual quality review meetings and customer complaints. The records are maintained by the Quality Department. Corrective action plans are agreed by authorized personnel (managers and supervisors). Verification of the effectiveness of the corrective actions is monitored via ongoing quality and audit checks to ensure satisfactory completion. Specifications are available for all raw materials and finished products. Specifications reviewed were current, accurate, and ensured legal and safety compliance. This is written in document revision 6 dated September 25, 2012 (Non-Conformance Materials). FUNDAMENTAL Statement of Intent The company shall be able to demonstrate that they use the information from identified failures in the food safety and quality management system to make necessary corrections and prevent recurrence. Choose an item The company shall have a documented procedure for handling nonconformances identified within the scope of this Standard to include: clear documentation of the non-conformity assessment of consequences by a suitably competent and authorized person identification of the corrective action to address the immediate issue identification of an appropriate timescale for correction identification of personnel with appropriate authority responsible for corrective action verification that the corrective action has been implemented and is effective identification of the root cause of the non-conformity and implementation of any necessary corrective action. Choose an item. 3.8 Control of non-conforming product There is a program to prevent the release of non-conforming product. This is in document revision 6 dated September 25, 2012 (Non-Conformance Materials). The product is marked with a hold tag and is located in a segregated area of the refrigerated or frozen area of the facility. There are records of destruction and Page 25 of 60

26 methods of disposal in the procedure. The company shall ensure that any out-of-specification product is effectively managed to prevent release There shall be documented procedures for managing non-conforming products which include: the requirement for staff to identify and report potentially non-conforming product clear identification of non-conforming product, e.g. direct labeling or the use of IT systems secure storage to prevent accidental release, e.g. isolation areas referral to the brand owner where required defined responsibilities for decision making on the use or disposal of products appropriate to the issue, e.g. destruction, reworking, downgrading to an alternative label or acceptance by concession records of the decision on the use or disposal of the product records of destruction where product is destroyed for food safety reasons. 3.9 Traceability All materials (ingredients and packaging) are coded upon entry to the facility to allow traceability. The formulas in processing have all lot numbers written so that ingredients/packaging may be traced from introduction into finished product. The plant conducted a mass balance trace exercise was on Organic Grape produced on September 26 and 27 th There was a an acceptable reconciliation of the ingredient. The exercise took less than 4 hours. The auditor conducted a mass balance trace exercise on strawberries from the field to final product. The production day was August 1, The lot was IDEB; the amount used was 85,000 lbs. There was a reconciliation of 97% with the exercise taking less than 4 hours. There is reworked material which has documentation of use in product. FUNDAMENTAL Statement of Intent The company shall be able to trace all raw material product lots (including packaging) from their supplier through all stages of processing and dispatch to their customer and vice versa Identification of raw materials, including primary and any other relevant packaging and processing aids, intermediate/semi-processed products, part used materials, finished products and materials pending investigation shall be adequate to ensure traceability The company shall test the traceability system across the range of product groups to ensure traceability can be determined from raw material to finished product and vice versa, including quantity check/mass balance. This shall occur at a predetermined frequency and results shall be retained for inspection. The test shall take place at least annually. Full traceability should be achievable within four hours Where rework or any reworking operation is performed, traceability shall be maintained. Page 26 of 60