Supplier Excellence General Requirements

Transcription

1 Supplier Ecellence General Requirements Consumer Goods General Merchandise & Non Trade

2 Table of Contents Contents SECTION 1 - Product Design and Risk Assessment SECTION 2 - Product Control and Process Control SECTION 3 - Company Commitment SECTION 4 - Internal Audit SECTION 5 - Approved Supplier & Raw Material Management / IQC Program SECTION 6 - Control of Non Conforming Product SECTION 7 - Product Identification and Traceability SECTION 8 - Complaint Handling SECTION 9 - Incident Management SECTION Factory standards SECTION 10 - Site Security SECTION 11 - Premises and Layout SECTION 12 - Preventive Maintenance SECTION 13 - Personnel - Training and Competency SECTION 14 - Pest Control SECTION 15 - Environment and Waste Practices SECTION 16 - Storage, Dispatch and Transport SECTION 17 - Product Inspection & Testing SECTION 18 - Calibration SECTION 19 - Product Sample Control SECTION 20 - Quantity Control SECTION 21 - Specifications and Technical Files SECTION 22 - Occupational Health and Safety 2018 Woolworths Ltd. Authorised Eternal Distribution Page 2 of 19 Document: SEP.30- Supplier Ecellence General Requirements

3 Supplier Ecellence General Requirements - Consumer Goods To help identify how the requirements must be met for each clause a P, R or O will be indicated under the columns headed PRO. These columns indicate whether the requirement is met through: P = Procedure. - A documented procedure that has been fully implemented. R = Record. - Documented and accurately completed records. O = Observation. - Compliance will be checked through observation. SECTION 1 - Product Design and Risk Assessment The factory must demonstrate that product safety is considered through the design process. Risk assessment is to be completed for all products during the design stage and effective controls to manage the identified risk are to be implemented into the production process. Legislation and Safety Requirements 1.1 The site must demonstrate knowledge of all applicable legislation, product standards and product safety issues in place of production and regions of intended sale of each product. These requirements must be integrated within the Quality Management System including controls to be implemented to ensure compliance. Product Risk Assessment 1.2 A procedure for the full assessment of the safety and legality of each product or product group must be completed and be appropriate for the intended market. Records must be available to demonstrate the safety and legality of the product. Where the assessment has been completed by a service provider or by the customer, confirmation of the safety and legality of the product must be available. 1.3 For each product risk assessment the following documentation must also be available a description of the product assessed (for eample, approved samples or mock-ups, sample drawings, computer graphics, photographs, specification) the intended use of the product and foreseeable abuse conditions the hazards, and whether the risk is acceptable the date performed, name of the person responsible and the evidence from which the assessment was derived. 1.4 The assessment must be undertaken by suitably trained and competent internal or eternal resources. Evidence of this must be available. 1.5 The assessment must be reviewed whenever changes occur to specification, legislative requirements or in response to significant changes in production methods, complaints or incidents with the product or similar products Woolworths Ltd. Authorised Eternal Distribution Page 3 of 19 Document: SEP.30- Supplier Ecellence General Requirements

4 1.6 Where there is a legal requirement to do so or when it is necessary to confirm its safety or legality, a representative product should be submitted for testing to a suitably qualified and, where applicable, an accredited laboratory (internal or eternal). The results of the test should form part of the risk assessment. 1.7 A risk assessment needs to be completed where new processes are implemented which could change the program of controls for product safety or quality.these must be documented and discussed with Woolworths. 1.8 Where legally required, the identity, competence, qualifications and/or licence of the person producing the safety review or risk assessment must be documented and verified. 1.9 Where the risk assessment identifies key controls are required to mitigate the hazard these controls must be documented and implemented within the production process Record of these control points checks must be implemented and maintained. Product Labelling and Claims 1.11 The site must have a process that ensures they verify that information shown on primary (consumer) package labels and outer cartons is correct and meets the regulatory and safety requirements of the region of intended sale The site must have a process in place to ensure that any claims made about a product must be fully validated to ensure that products meet the stated claim Where applicable, the site must ensure that product evaluation during use, reliability trials and shelf-life tests are validated. It must be verified that the production of a safe and legal product is maintained, taking account of the category of consumers at risk eg ; babies /children Packaging Materials 1.14 Packaging must be assessed for fitness for purpose and must be suitable with regards to: protecting the product from damage maintaining product integrity protecting the consumer from injury preventing contamination. Records of this assessment must be maintained. Codes of Practice for Categories may prescribe additional packaging requirements Woolworths Ltd. Authorised Eternal Distribution Page 4 of 19 Document: SEP.30- Supplier Ecellence General Requirements

5 SECTION 2 - Product Control and Process Control The supplier must ensure that process control is implemented throughout the production process to ensure product safety and quality is maintained. The supplier / factory must ensure that finished product is not released unless all procedures (FQC) have been followed and the required customer release procedures have been completed 2.1 A documented process for the manufacture of the product must be completed. All IQC, IPQC and FQC must be documented and records of these checks maintained. 2.2 The controls must be aligned to the product risk assessment to ensure product safety and quality is maintained throughout the production process. 2.3 Controls for release of finished product must be documented; this should include customer specific requirements and appropriate personnel for release of product. 2.4 Records of review of records for product release must be documented and maintained. This should include demonstrated compliance to the Woolworths approved specification. 2.5 Where a product does not meet specification records must be maintained of the agreed actions with the Woolworths quality team Pre-shipment inspection must be completed where required by 2.6 Woolworths. Records must be maintained SECTION 3 - Company Commitment The site s senior management must demonstrate they are fully committed to the implementation of the requirements of the Woolworths Supplier Ecellence Program, and to the processes which aid the continual improvement of product safety and quality management. 3.1 Senior Management must demonstrate their commitment to the effective implementation of the requirements of the Supplier Ecellence Standard and must provide the resources necessary to meet the requirements of the standard. This must include evidence of commitment to product safety, quality and legality of all product supplied to Woolworths Ltd. Coverage for deputy personnel with responsibility for legal, safety, and quality is available and documented Woolworths Ltd. Authorised Eternal Distribution Page 5 of 19 Document: SEP.30- Supplier Ecellence General Requirements

6 3.2 The Supplier must employ a technically competent staff member(s) who holds responsibility for the day-to-day operation and development of the quality management system. A responsible representative of this technical team or a trained delegate must be available on site for the duration of all shift production activities, including overtime. The technical / QA representative shall be independent of the production or operations management. QA must have the accountability to stop production where product safety is at risk. The technical representative must have a direct link to authority on product safety, legality and quality matters. 3.3 The site must have an established Quality Management System in place which is appropriate for the size of the business and the risk associated with the products produced. The quality management system requirements must be fully integrated into the site s production activities, and responsibility for these operations managed by the operations function. 3.4 The site must operate an effective document control system to ensure that only correct approved versions of documents including recording forms are available and in use. SECTION 4 Internal Audit The site must be able to demonstrate that it verifies the implementation of the Quality management system (QMS) through an internal audit program. 4.1 The internal audit program covering the key requirements of the QMS must be developed and implemented to ensure that all key components of the QMS are verified on an annual basis 4.2 Internal audits must be carried out by suitably trained competent auditors who can demonstrate an understanding of the Woolworths Supplier Ecellence Program 4.3 The results of internal audits will be recorded and where required corrective action plans implemented for identified non conformities. 4.4 Results of Internal Audits are to be reviewed by management and records maintained Woolworths Ltd. Authorised Eternal Distribution Page 6 of 19 Document: SEP.30- Supplier Ecellence General Requirements

7 SECTION 5 Approved Supplier & Raw Material Management / IQC Program The company must have an effective supplier approval system which monitors all raw materials and packaging for safety, authenticity, legality and quality. 5.1 Suppliers must have a documented Approved Supplier Program in place for all suppliers of product which is packed, processed or distributed to Woolworths and must ensure all purchased inputs comply with all regulatory requirements of the country of manufacture and sale. The Approved Supplier Program includes primary, secondary and contingency suppliers of all key items. Full details will be in the category specific requirements. 5.2 Contract packers and subcontracting facilities are considered a purchased input. These businesses are required to hold current supplier approval (including recognition through audit scope) from Woolworths for the approval of these subcontracting arrangements Formal agreements must be obtained for any contract service used by the Supplier. These agreements must demonstrate that product safety, quality and regulatory aspects have been addressed with effective control measures documented and implemented where necessary. 5.4 A documented risk assessment must be carried out to assess each purchased input (or group of similar inputs) for safety, quality or regulatory hazards. Specific requirements may be detailed in the category specific codes of practice. 5.5 The process for selection of a new supplier and ongoing approval of an eisting supplier must be documented and implemented. The approval process may utilise more than one approval method but it must be based on the risk assessment Woolworths Ltd. Authorised Eternal Distribution Page 7 of 19 Document: SEP.30- Supplier Ecellence General Requirements

8 5.6 The Supplier Approval Program must include, at a minimum: The approval criteria used for each supplier / purchased input. Records of within date certificates and scope of certification where independently audited food safety or quality certification programs are used. Records of supplier audits (second party audits), their reviews and closure of corrective actions. Questionnaires and technical review of the supplier s responses (if used). Methods of review and verification of the results shown on Certificates of Analysis where these are provided by the supplier. Note these must be per delivery/batch purchased. Methods for removal of suppliers from the approved supplier program Methods for use of emergency suppliers, the circumstances in which these are permitted and any Specific process controls required. Methods for technical review of raw material, finished specifications or the service contract. The frequency of review of approval method for each supplier. Methods of ensuring suppliers communicate any changes which impact or may impact on a purchased input s safety, quality or regulatory attributes. Evidence that suppliers operate effective traceability. 5.7 A list of suppliers/products and their current status must be maintained and be accessible at point of receipt of goods or service. 5.8 Where the risk assessment has identified a purchased input could be a safety, quality or regulatory hazard, a method of controlling the risk must be developed, documented and implemented to control the hazard Woolworths Ltd. Authorised Eternal Distribution Page 8 of 19 Document: SEP.30- Supplier Ecellence General Requirements

9 5.9 A monitoring plan (IQC process) must be developed and implemented to assess compliance of purchased inputs to raw material specifications. The methods of assessment must be documented and records of the evaluations maintained. Where incoming goods or services do not meet specification, corrective actions must be documented, and records must be maintained including the resultant action applied to the affected raw materials. The evaluation documentation must include the following: Confirmation of compliance to all relevant regulatory requirements in the country of production and the country of sale. Assessment and approval in accordance with the approved raw material specification. Quantitative parameters of acceptance/rejection criteria (from specification). Methods of assessment of incoming goods, including inspection levels and type of test (destructive, visual, analytical). Collection and use of retention samples ( where appropriate based on risk assessment) Code labelling and date marking requirements including date of receipt and stock rotation methods The Supplier must document and implement procedures for performance review of approved suppliers. Records must detail any actions taken (e.g. cease purchase, increase surveillance and monitoring, positive feedback on performance). Any review meetings held with suppliers must be documented and actions closed Woolworths Ltd. Authorised Eternal Distribution Page 9 of 19 Document: SEP.30- Supplier Ecellence General Requirements

10 SECTION 6 - Control of Non Conforming Product The Supplier must develop, document and implement procedures to identify and manage items at any stage of the process which are found to be out of specification. 6.1 Assessments and decisions regarding non-conforming product must only be made by authorised, trained and accountable personnel. Records of non-conforming product must be maintained and include: Reason for non-conformance Investigation to the source of the issue Corrective actions Final disposition (re-work, donation to charity, destroyed etc.) 6.2 Records of non-conforming products must be subject to trend analysis to identify ongoing issues. All non-conforming products (including that to be re-worked) must be clearly identified and securely stored to prevent accidental use. 6.3 A procedure must be implemented for the destruction of any Woolworths branded product or packaging which has been rejected through the production process or by Woolworths, any discontinued or obsolete packaging and product which is not fit for purpose. This procedure must detail notification to the Woolworths team and the methods for destruction. 6.4 A stock rotation policy and procedures for raw materials, work in progress and finished product must be documented and implemented. Procedures must ensure that: The oldest products or materials are used first Raw material shelf life does not eceed finished product shelf life unless validation data indicates finished product quality & safety are not compromised Out of date materials must not to be used 2018 Woolworths Ltd. Authorised Eternal Distribution Page 10 of 19 Document: SEP.30- Supplier Ecellence General Requirements

11 SECTION 7- Product Identification and Traceability Product Identification 7.1 The Supplier must document and implement procedures to ensure all materials used in or produced by production processes are clearly identified. Identification may be through on-product labelling, coding or IT management systems. This includes: Raw materials Packaging (Primary and shipper) WIP Rework Waste Materials Non-conforming product Finished products Traceability 7.2 A procedure must be developed, documented and implemented such that all material and inputs are traceable through all stages of the site s processes. 7.3 Quality System records and all relevant production records in relation to the process must be identifiable to specific production / batch coding. 7.4 Finished product identification must be through product date marking and / or batch marking. Coding used must enable identification of the retail sale unit and the shipper / carton such that product may be identified and recovered at both consumer level and whilst in distribution. Product category requirements may list addition product identification and traceability requirements based on product risk or regulatory requirements. 7.5 During the audit where the supplier/ factory is a current Woolworths supplier the traceability eercise must be completed for products which have been previously shipped to demonstrate end to end traceability of Woolworths products 2018 Woolworths Ltd. Authorised Eternal Distribution Page 11 of 19 Document: SEP.30- Supplier Ecellence General Requirements

12 SECTION 8 - Complaint Handling The company must have a system in place to effectively manage customer complaints received from Woolworths. Customer Feedback & Complaints 8.1 A procedure for the management of customer feedback must be documented and implemented. This must include a procedure detailing how complaints are managed. Feedback includes positive comments and complaints. Complaints must include product rejections from Woolworths. 8.2 Customer complaints may be escalated to product withdrawal and/or recall based on the investigation of the complaint and the trend data. This process must be incorporated into the procedure. 8.3 Complaints must be assessed upon receipt and logged by a trained business representative. CorrecFve acfon must be promptly applied appropriate to the severity of the issue. It must demonstrate every effort has been made to obtain full details of the issue. Detailed records of communicafon with Woolworths. 8.4 Complaint investigations must include analytical and / or destructive product testing and assessment where a sample of the product can be obtained. Retention samples must be utilised as part of the investigation. Upon completion of the documented complaint investigation, the document must be signed off by a competent senior manager. All steps of the complaint investigation must be documented. The root cause of the complaint should be identified and documented. Corrective and preventative action must be taken.. SECTION 9 - Incident Management The company must have a system in place to manage incidents effectively enabling the withdrawal or recall of identified products should this be necessary. Product Withdrawal & Recall 9.1 The Supplier must have a documented product withdrawal/recall procedure for all products. This should include the requirement for an annual mock recall and the ability to complete a traceability eercise for all products supplied to Woolworths within a 2hr timeframe. Records of these must be maintained. This procedure must include the requirement for the Woolworths QA Team to be informed of issues regarding product safety, quality or regulatory compliance prior to any action being taken, or where appropriate actions include product withdrawal or recall are required Woolworths Ltd. Authorised Eternal Distribution Page 12 of 19 Document: SEP.30- Supplier Ecellence General Requirements

13 SECTION Factory standards SECTION 10 - Site Security Security must be maintained at the site to prevent unauthorised access to the production and storage areas Access to the site by employees, contractors and visitors must be controlled and a visitor-reporting system in place 10.2 Eternal Contractors involved in maintenance and repairs should be supervised by the factory maintenance team. SECTION 11 Premises and Layout Premises must allow sufficient working space and storage capacity to enable all operations to be carried out and, if necessary, in hygienic conditions. The necessary level of hygiene must be maintained appropriate to the product being manufactured Where materials or products require special handling procedures to be in place, these must be maintained to ensure product safety, quality and legality are not compromised. Category requirements may detail specific premises requirements 11.2 Materials and products requiring segregation (e.g. materials intended for different geographical regions, different suppliers) must have control procedures in place to ensure that product integrity is maintained The site must be maintained to minimise potential for product contamination. The quality and finish of site buildings and facilities, including any pipework and drainage, must be suitable for the intended purpose. To minimise the risk to product safety, legality and quality, an appropriate standard for factory standards must be established. This must include, as defined by the risk assessment: a clean, tidy and organised factory adequate lighting adequate ventilation walls, floors, windows, doors and ceilings maintained in a good condition to prevent foreign body risks suitable and sufficient removal of any by-products and contaminants Woolworths Ltd. Authorised Eternal Distribution Page 13 of 19 Document: SEP.30- Supplier Ecellence General Requirements

14 SECTION 12 Preventive Maintenance 12.1 A planned preventative (scheduled) maintenance program must be implemented for all sites, incorporating food process plant, equipment, premises and surrounds. A log of all equipment must be developed and maintained. Where multiple pieces of the same equipment are on site these must be individually identified. New equipment must be added to the planned maintenance schedule as recommended by the manufacturer. The site planned maintenance schedule must be reviewed and adjusted based on the equipment performance. The maintenance schedule must include equipment condition inspection as well as physical maintenance requirements Maintenance must be conducted by staff trained in the specific job or by contractors trained in the site s safety procedures 12.3 Where equipment breakdowns occur, the planned maintenance program must be reviewed as part of corrective action. Changes may be made to the program to prevent future breakdowns 12.4 Maintenance Procedures and methods used must ensure product safety or quality is not affected during maintenance tasks. Maintenance contractors must be supervised or their actions otherwise controlled. The use of temporary screening structures must be used during building works and/or where appropriate during equipment maintenance to prevent product contamination. Temporary (tape) engineering repairs must be minimised. These must not affect product safety, quality or legality and the use of temporary fies must be promptly documented and rectified with permanent solutions as soon as possible and within a defined time Chemicals used in maintenance processes must be identified, stored in a secure area and must not present a risk to product. Used chemical must be disposed of as per local regulations Maintenance workshops and engineering stores must be controlled, clean and pest proofed Woolworths Ltd. Authorised Eternal Distribution Page 14 of 19 Document: SEP.30- Supplier Ecellence General Requirements

15 SECTION 13 Personnel - Training and Competancy 13.1 The Supplier must have a documented training plan to ensure all staff are trained and supervised in the activities which they carry out. Training must meet or eceed legislative requirements where relevant The Supplier must demonstrate understanding of relevant legislative aspects e.g. Australian or NZ regulatory requirements for products, ACCC regulations, etc. If necessary, a source of epert advice must be available All new staff, permanent, casual or agency; visitors and contractors must be trained in product safety standards and site specific procedures including entry procedures, glass breakage, quality controls, illness and accident reporting as a minimum Activities which directly affect product safety, quality or legality must be identified. Staff performing these tasks must have job specific training or must otherwise demonstrate competency. This includes permanent and temporary staff. All staff must be supervised according to the risk nature of the task carried out. This includes all Critical Control Point and Quality Control Point monitoring and corrective action activities Includes training for those responsible for product release procedures 13.5 The Supplier must define the job specific skills required for the site. The Supplier must develop a training matri showing staff competency in site skills. The information gathered from the training matri must be reviewed and used to develop a training plan to ensure the site s ongoing needs are met. The matri must be kept up to date and reviewed minimum annually. Refresher training must be carried out for all staff at a suitable frequency irrelevant of length of service or eperience Training must be delivered in a language and style appropriate to the Supplier s business such that it is effective i.e. the literacy needs of the people are known and accounted for, e.g. with translated documents or verbal sessions Woolworths Ltd. Authorised Eternal Distribution Page 15 of 19 Document: SEP.30- Supplier Ecellence General Requirements

16 SECTION 14 Pest Control The whole site must have an effective pest control program in place to minimise the risk of pests The factory must ensure that they have an effective pest control program in place to identify and control pests within the factory environment. SECTION 15 Environment and Waste Practices Waste disposal must be managed in accordance with regulatory requirements and be effectively managed to prevent pest infestation at the factory Waste disposal and waste water management must be managed in accordance with regulatory requirements and also to ensure no environmental impact occurs in the surrounding area to the factory. Records of compliance requirements for waste disposal must be maintained. SECTION 16 Storage, Dispatch and Transport Facilities for the storage and transportation of products must be suitable for purpose and minimise the risk of product contamination, damage and malicious intervention All materials, work in progress and product must be properly identified and protected during storage by appropriate packaging to protect the product from contamination Vehicles or containers used for transportation and dispatch of product must be inspected prior to loading to ensure that they are fit for purpose. Records of inspection must be maintained Where storage of raw materials, components, packaging, intermediate or finished product is necessary it must be maintained in good condition and be securely protected from contamination, deterioration and damage Woolworths Ltd. Authorised Eternal Distribution Page 16 of 19 Document: SEP.30- Supplier Ecellence General Requirements

17 SECTION 17 - Product Inspection & Testing The company must have a programme for product inspection and testing to control products during and after production to ensure that products are safe, legal and meet the quality specification The testing programme must be implemented and records kept of all test results. Results which are: Outside the defined specification must be reviewed promptly by an authorised competent person. The need for corrective action must be assessed and documented, and any action carried out as necessary There must be a scheduled product-testing programme according to risk for each product or product group as defined in the specifications. This must be based on information such as: the outcome of the product and process risk assessments any legal requirements for testing in the regions(s) of intended sale the site s requirements for demonstrating the production of safe products. the methods, frequency and specified limits of testing must be clearly defined Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors must have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC Product category requirements may list addition product testing requirements based on product risk or regulatory requirements. SECTION 18 - Calibration Measuring equipment used to monitor product safety, quality and legality must be calibrated and of suitable accuracy for its intended purpose The site must have a list of equipment used to make measurements relevant to product safety, legality and quality The equipment used to accept or reject a product must be calibrated to a specified accuracy and precision at a defined frequency (or before use) Woolworths Ltd. Authorised Eternal Distribution Page 17 of 19 Document: SEP.30- Supplier Ecellence General Requirements

18 SECTION 19 - Product Sample Control The site must ensure that procedures are in place for the selection, handling, storage, approval and use of reference samples taken from pre-production, subcontracted and finished production in accordance with customer requirements The supplier/factory must demonstrate management of the Woolworths approved reference samples of the product. Where a sealed sample has been approved this should be securely stored and a copy of the agreed specification must be retained on site A procedure must be implemented to determine the retention time for approved samples. This should be agreed with Woolworths and be aligned with regulatory and customer use requirements The sealed sample and approved specification must be used on the line during production of Woolworth s products. SECTION 20 - Quantity Control The site must operate a quantity control system which conforms to the legal requirements in Australia and New Zealand 20.1 Where quantity checking is required for the product,the frequency and methods used for checking must be documented and records maintained for Woolworths products 20.2 These methods must be based on valid sampling plans that ensure compliance to regulatory requirements Product category requirements may list addition product quality control requirements based on product risk or regulatory requirements. SECTION 21 - Specifications and Technical Files A system must be in place to ensure technical files and specifications for all raw materials, packaging and components for Woolworths products is maintained An approved specification must be available for all Woolworths Own Brand products 21.2 A procedure for ensuring the effective management of technical files and product specifications in production must be implemented A technical file shall be in place for all Woolworths products which includes the following : a) Risk Assessment b) Safety data sheets c) Components specifications d) third party test reports e) labelling/ artwork f) packaging information g)regulatory approvals where required 2018 Woolworths Ltd. Authorised Eternal Distribution Page 18 of 19 Document: SEP.30- Supplier Ecellence General Requirements

19 SECTION 22 - Occupational Health and Safety A system must be in place to ensure people safety is effectively maintained within the production areas Where know hazards are evident in the production area the factory management must ensure personnel protective equipment is be implemented within the production areas to prevent worker injuries Machines guards must be in place on equipment to prevent worker injury Appropriate protective equipment such as earplugs, safety shoes and safety glasses must be provided to all visitors who enter the production area Woolworths Ltd. Authorised Eternal Distribution Page 19 of 19 Document: SEP.30- Supplier Ecellence General Requirements

20