Woolworths Quality Assurance

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1 How to Conduct an Effective Pre-Operational Inspection INTRODUCTION & OBJECTIVE: A Pre Operational Inspection (POI) Programme is an essential tool to ensure that food safety, foreign body, allergenic and chemical hazards are inspected prior to manufacturing/ packing commencing. If any issues are identified, corrective action is undertaken prior to area or line start up. Lines will be suitably cleared and to ensure they are ready for production with CCP's and QCP s correctly set. For example, correct packaging on line, and metal detectors checked. For all manufacturers and packers, an effective pre operational program is critical in the prevention of incidents leading to product issues which may result in a withdrawal or recall of our product. Detection systems such as metal and x ray provide a level of comfort for manufacturers, however we need to strive for prevention and eliminate hazards to ensure we deliver a much more robust and safe product to our customers. Most post incident reviews identify that the issue causing a product withdrawal or recall could have been prevented with more diligent monitoring, effective corrective actions and control of nonconforming product. FREQUENCY: Effective POIs vary for all manufacturers and it is important that they are regularly reviewed to ensure that all risks are covered and that the person completing the checks is competent and has the authority to approve line start up for each shift. Where a site has multiple shifts per day the expectation is that checks are completed a minimum of once per shift or product change over. For extended runs the risk and frequency needs to be assessed to determine the checks required. The effectiveness of a POI would also be required and evaluated as part of a root cause analysis due to a customer complaint or withdrawal/recall. It is important to allow sufficient time to conduct the POI. These need to be scheduled into production runs, and start up times, to ensure they are conducted consistently and effectively. This includes during peak production periods. RESPONSIBILITY: The Manager or Supervisor responsible for the area/ production/ packing line conducts the POI, and is accountable to sign off that the line is ready for start up. The QA team is responsible for undertaking audits of the POI and also for undertaking their own programme of POI. Findings are recorded so that corrective actions and trend analysis can be undertaken. You need to consider who within your site has authority for line start up checking and approval? Are they trained? Are they aware of the corrective actions required when an issue is found? Have they become site blind to the issues surrounding them? Are they held accountable for the checks that they complete? Page 1 of 6

2 How often the completed checks are independently reviewed in an internal audit? Specific focus is required to challenge and deliver continuous improvement. PROCEDURE EXPECTATIONS: To conduct the POI inspect and check the following. Maintain a record for each point, clearly noting whether there is conformance or non conformance. In the event of non conformance, corrective action and clearance will be required from a Manager, Supervisor or QA before the line is started or an area is used. Personnel responsible for undertaking POI inspections must be trained in how to undertake the inspection and also in suitable corrective actions in the event of a non conformance. The POI inspection should include all areas including under and on top of equipment and should include a 360 degree sweep of the line and surrounding area. The sections or areas below are a guide of what should be considered are not an exhaustive list, and your own sites processes, equipment and facilities should be considered when developing your POI: Personnel Facilities Staff hand wash facilities are clean with supplies of hand soap, sanitiser and hand towels are available. If paper hand towels are used ensure the bin is empty and clean. Staff protective clothing is clean, in a good state of repair and available including hats, hard hats, hairnets, beard snoods, protective coats, aprons, gum boots or safety boots, gloves etc. Ensure that stocks of colour coded protective clothing used for allergen or hygiene purposes are available in the area required. Personnel Controls Ensure all staff are washing hands correctly, wearing the correct protective clothing and that all hair and beards are covered before starting work in their area. Confirm that jewellery, fingernail and make up controls are adhered to and that no one has personal belongings with them such as mobile telephones, cigarettes or medicines. Ensure staff do not provide entry to non approved items such as pens. Storage, Despatch and Transport Areas All storage areas are clean and free from foreign matter such as cardboard, plastic and pallet wood. This includes any racking or high level storage. Ensure that wooden pallets are in use only in permitted areas eg storage and enclosed product areas. Page 2 of 6

3 All areas are free from spillages especially allergens. Also that goods are in the correct storage locations eg meat, vegetarian, allergen, packaging and chemical items. Raw materials and packaging are not stored directly on the floor or against the walls. All items are covered, sealed or closed. Confirm that all goods are within their best before or use by date. Check that any goods on hold or with a concession are clearly identified and correctly located. All doors are closed and close fitting eg no gap underneath or at the sides to allow pest ingress. Check that temperature controlled areas are operating within the correct temperature range. For any external storage ensure that all goods are covered and labelled. For silos and tanks check that security locks are in place and that loading points are clean. Forklift trucks, battery charging areas or fuelling areas are clean and free from foreign matter such as flaking paint or cracked glass (including gauges and light covers). Also from chemical hazards such as batteries, fuel etc. Internal Factory/ Production Offices Ensure only permitted items are found in internal factory offices eg there are no staplers, hole punches, paper clips, wooden items or fabric covered chairs etc. Confirm there is no evidence of eating, drinking and storage of personal items such as mobile phones, personal medicines, mugs, glasses crockery, cutlery, factory knives, uncontrolled chemicals, lunch boxes etc in internal factory/ production offices. Internal Product Sampling Areas Check that only listed permitted items are in use eg paper plates, plastic forks, paper towels and that the area is clean and well maintained. Ensure that any equipment such as ovens or microwaves are undamaged and intact with no cracked or broken glass or chipped paint. Ensure that fridges or freezers are operating at the correct temperature and that this is recorded. That sample stocks are rotated and correctly dated. Hand wash facilities are clean with supplies of hand soap, sanitiser and hand towels are available. If paper hand towels are used ensure the bin is empty and clean. Page 3 of 6

4 Packaging & Date Coding Checks (all lines) For each production run, prior to line start up, all items of packaging must be confirmed to be correct according to the specification. This includes the correct tray, labels, film, sachets, and other inserts such as oxygen scavengers and/ or soaker pads. For each production run, prior to line start up and for each packaging batch change, all printed packaging must be confirmed to be the correct version in use this to include top and bottom labels, printed film, sleeves and all promotional labels. For each production run the lot or batch code, the correct use by or best before date including the year, the correct format of the date code and the legibility of the date code must be confirmed to be correct. Large Equipment (all areas) Check equipment is maintained in a good condition with no foreign body risks eg fraying/ damaged conveyor belts, brushes with bristle loss, cracked plastic covers/ windows, damaged chopping boards, damaged blades etc. The equipment should have no loose parts, such as bolts, nuts, washers, screws or rivets. Ensure that blades, mincers and paddles are in tact and undamaged at the start and end of each shift (as a minimum). Ensure equipment is clean with no chemical residues or visible debris present (this is to include other cleaning verification has taken place as required based on risk eg. swabbing to verify cleaning effectiveness). Check under, over and behind equipment. This needs to include where equipment, such as conveyor belts run above or over exposed product, so that they are not a risk of contaminating product. No tools or equipment parts should be left on the top or stored on the sides of equipment where it may accidentally fall into product. Small Equipment (all areas) Check that all items of metal equipment such as knives, scissors etc are signed in and out of use at the start and end of each shift. The check is to include inspection for damage or loss of blade pieces. Page 4 of 6

5 Check that all items of plastic equipment such as scrapers, scoops etc are checked for damage at the start and end of each shift. Ensure that product trays, tote bins and other storage equipment is not damaged, cracked or chipped. Remove damaged items from service. Glass & Hard Plastic (all areas) Glass, hard plastic and glass like materials such as plastic covers, knobs, sight glasses, buttons etc are listed for each area and are checked for damage at the start and end of each shift. Filters & Sieves (all areas) Sieves and filters are checked at the start and end of each shift to ensure they are in tact. If not intact correctives actions including product produced since the previous in tact check must be documented. General Foreign Body Controls (all areas) Damaged equipment and trays are not in use and food containers such as trays are not being used for storage of other items. Check that labels, signs and notices are in tact, are not peeling off or deteriorating, and do not pose a foreign body risk. Cardboard boxes and plastic bags to be opened without ripping and cardboard not permitted in open product areas. Factory Hygiene All Areas (Deep Clean and Interim Clean) There are no visible chemical residues remaining after hygiene activity (deep clean or interim clean). Hygiene sign off checks have been undertaken. ATP swabs or allergen swabs (for designated areas or equipment), where required, have been undertaken and checked prior to line start up. All cleaning equipment is well maintained with no damaged handles, bristles etc and is suitable for use. Cleaning equipment is colour coded for each purpose, clean and dirty segregation is in use and clean equipment is stored upside down. Cleaning chemicals are correctly labelled, locked and correctly dosed. Engineering (all areas) Page 5 of 6

6 Where maintenance activity has taken place ensure that there are no metal shavings (swarves), or weld drops/ pieces, tools or loose parts such as nuts, screws, bolts, rivets left in the area or equipment. Excessive lubrication is avoided and only food grade chemicals such as silicone spray, greases or lubricants are in use. Temporary repairs should not be used, but where necessary they must only for used for a documented and limited period of time (and must be regularly inspected to ensure they are not a risk of contaminating product). Pest Control (All Areas) Check that pest control bait boxes are robust and intact. Check insect killing units are working with all bulbs lit. Sticky pads/ boards should be checked to ensure they are not overloaded Corrective actions when issues found in POI: If any of the above are identified as non conforming during a POI, procedures must be in place to assess the risk of the non conformance contaminating or compromising the previous production e.g. missing nuts, unaccounted for equipment, broken light fittings, wire etc. Ensure that you consider: Are systems in place to identify and hold stock whilst a risk assessment of the manufactured product is completed? Where the product has been released what monitoring records are available to identify capture of the contaminant e.g. metal detector, x ray. Using a root cause analysis tool to determine the root cause and implement preventive actions to stop recurrences of the problem. Effective corrective action helps ensure the production line/ area or packing line is ready to start and there is confidence that the facility, equipment or people cannot contaminate product. Preventive action implementation will drive safe, quality product manufacture and packing as well as improve efficiencies for the facility. Page 6 of 6

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