Clause no Details of Changes Type of Change
1.2.2 MRM - Review of second party audit results MRM Agenda
2.2.2 The hazard and risk analysis team shall maintain awareness of and take into account of known likely product defects that affect safety or quality Training
2.2.4 Flow diagram also shall include in-line testing and measuring equipment's Documentation
2.2.5 Hazard and risk analysis of each step also consider potential for unintended migration of substances from the packaging material into food or other
• potential for malicious intervention. Documentation
2.2.6 Controls for identified hazards to product quality shall be appropriately managed through the prerequisite programme, as set out in section 5. Documentation
2.2.11 HARM system review shall also include verification of
• process changes
• product composition changes Documentation 3.2.1 Document Control shall also include
• the method for the identification and authorisation of controlled documents
• a record of the reason for any changes or amendments to documents Documentation
3.8 Service providers shall be managed as per 3.8 Site Activity
3.8.1 A documented procedure for approval and monitoring of suppliers Documentation
3.8.2 Documented agreements shall exist with the suppliers of services which clearly define service expectations and ensure potential risks associated with the service have been addressed Documentation
3.9.5 Traceability shall also include, Where rework or any reworking operation is performed Site Activity
3.10.2 Customer needs and expectations shall be documented Documentation
3.10.3 Where customers have set particular performance criteria or indicators for monitoring, these requirements shall be communicated to relevant staff, adhered to, and intervals. Reviewed at appropriate Site Activity
3.11 Complaints related to product hygiene shall also be effectively managed Documentation
3.11.2 Complaint data shall be analysed to identify significant trends. Where there has been an increase or repetition of a complaint type, root cause analysis shall be used to Documentation
3.12.1 product recall shall also include root cause analysis Documentation
4.2.2 suspended ceilings accessible for cleaning and inspection for pests unless the void is fully sealed.
4.2.5 Where they constitute a risk to product, and based on the likelihood and risk of non-production glass contamination, all bulbs and strip lights, including those on flying-insect control devices, shall be adequately protected. Site Activity
4.4.1 Identified security arrangements to reduce risks shall be documented, implemented and reviewed at least annually. Documentation
4.5.1 There shall be a plan of the site which defines:
• access points for personnel
• travel routes
• staff facilities
• process flow
• storage areas.
Documentation 4.6.3 Wooden equipment including desks, chairs, tables, etc. shall be properly sealed to enable effective cleaning.
Site Activity 4.7.4 removed and equipment cleared to resume production. A documented clearance procedure which records that contamination hazards have been
Documentation 4.8.2 Documented cleaning procedures shall be in place
Documentation 4.8.3 Cleaning chemicals shall be stored in a secured, designated location, in closed containers.
Chemicals Site Activity 184.108.40.206 Processes shall be in place to manage the use, storage and handling of non-production chemicals, to prevent chemical contamination. These shall include as a minimum:
• a list of approved chemicals for purchase
• availability of material safety data sheets and specifications
• avoidance of strongly scented products
• the labelling and/or identification of containers of chemicals at all times
• designated storage area with access restricted to authorised personnel
• use by trained personnel only. Documentation
4.10.1 Waste Management - Where licensing is required by law for the removal of waste, it shall be removed by licensed contractors
Site Activity 5.4.3 A bill of materials and process specification (including manufacturing process control points) shall be available for each batch or lot during production.
Documentation 5.5.1 The site shall identify and control in-line and off-line measuring equipment used to monitor critical control points (where applicable) and product safety, quality and legality. This shall include as a minimum:
• a documented list of equipment and its location
• an identification code and calibration due date
• prevention from adjustment by unauthorised staff
• protection from damage, deterioration and misuse.
Documentation 5.5.3 Corrective action and reporting procedures shall be established and documented in the event of the monitoring and testing procedure identifying any failure of product inspection, testing or measuring equipment. The site shall conduct a root cause analysis into the equipment failure and implement the appropriate
Documentation 5.6.5 Routine off-line quality checks shall be carried out at appropriate stages in production to demonstrate that the product is within the tolerances laid down in the agreed product specification. A system, which includes off-line or randomised quality checks, shall be in place to identify and remove non-conforming product from the production lot and ensure that any appropriate action is taken in consideration of the root cause Site Activity
5.8 INCOMING GOODS
Site Activity 5.9 STORAGE OF ALL MATERIALS AND INTERMEDIATE AND FINISHED PRODUCTS
Site Activity 6.1.2 training and competency assessment
• product inspection, testing and measuring
• printed packaging controls
• operatives at manufacturing process control points.
Site Activity 6.1.4 Records of training shall also include duration of training
Documentation 6.2.1 Compliance jewellery with the requirements shall be checked routinely.
Site Activity 6.3.10 Drinking of water from purpose-made dispensers and/or by using disposable conical cups or spill proof lidded containers may be allowed, provided it is confined to a equipment. Designated area away from
Site Activity 6.5.1 Hazard and risk principles shall be used to determine the need for protective clothing, including garments and footwear in raw materials handling, preparation, production and storage areas. Documentation