L10 What are the main benefits for a company to obtain ISO certification?
Added on 2020-09-08
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Challenge question 2 1-20L101.What are the main benefits for a company to obtain ISO certification?-It is the most important quality management standard in the world-Adopted by thousands of companies-Can control quality, save money-Customers demand it-Regulations may require it-Competitors are doing it2.What are the major document requirements for an ISO 9001 –based QMS?ISO 9001:2008 requires QMS be documented in:Quality policyQuality manualQuality proceduresWork instructionsRecords and forms3.What are the main ISO 9001 requirements on document control?A documented procedure to ensure documents are current and authorised, covering:approval prior to issueprocess to review and revise documentsidentification of issues and changesavailability of current issuesidentification and legibilitycontrol of documents of external originprocesses to prevent unintended use of obsolete documents4.What are the major ISO 9001 requirements on management?-establish quality policy-establish quality objectives to support quality policy ( specific, measurable, achievable, realistic, time-based)-documentation, and control it.Also resource management: for HR (train employee), work environment, physical Assess the performance of QMS processesAssign roles, responsibilities and authoritiesManagement representativeCommunicate
Maintain system integrity Review to assess opportunities for improvement and need for changes5.What are the major ISO 9001 requirements on human resources management?Employees must be qualified or trained for the job they are performing:Identify qualifications and training requirements for their jobEmployee must complete all required training. This may be on- the-job training, group training, or individual training.Evaluate the effectiveness of the training QuizzesObservation workPerforming to specificationsOther ways of evaluationL126.What are the key information do you need to include in raw material/ingredient specifications?Key elements:A description of the ingredient and intended useInformation on package and pallet configurationStorage conditions and shelf life informationDetailed list of physical, chemical, and microbiological requirements, including tolerance limitsany certification requirements such as organic, non-GMO, kosher, and halal, etc.7.How do you assess a potential supplier’s ability to meet your specifications?To ensure your supplier have:Financial capability and stabilityAbility to meet specifications:Request information on supplier’s quality systemEvidence of vendor’s quality system：TQM：HACCP：GMP：Pest control：Other quality systemVendor’s previous performanceVendor’s reputationTests on representative samples8.What are the major areas covered by GMP?Premises and facilities: location, design, maintenance, etc...Personal hygiene: employees and visitorsCleaning and sanitation*Control of operations
TransportationTrainingTraceability and recall9.With reference to the principles of GMP, what major considerations should be givenwhen selecting a food manufacturing site?LocationFood processing or storage buildings should not be located near sites that are sources of:environmental pollutantspest infestationssmoke or dustwastes stagnant water other potential contaminationLocation: should not be located near sites that are sources of environmental pollutants, pestinfestations, smoke or dust, waste, stagment water and other potential contaminationsource10.With reference to the principles of GMP, what considerations should be given to building ground, exterior and interior of the manufacturing plant?Groundsadequately sloped and drainedfree of waste and debriscontrolled for dustadequately maintained to protect against becoming a source of contamination or pest infestationInclude grass and lawns, hedges, plants, storage of garbage, and any structures located on the groundsInclude also building perimeter, parking lots and roadwaysBuilding exterior Not allow entry of contamination and pestsPrevent leakage of water into the buildingExterior walls free of cracksScreen openings for exhaust fans, air ducts and drainpipesProtect loading areas, exterior doors and windows to prevent entry of pestsExterior lighting should not attract pestsBuilding interiorDesign and layoutStructuresGlassCorners and joints
FloorsWindows and doorsLightingVentilationDrainage and sewage systems11.What are the major elements of a pest control program for a food manufacturing sitePest control program should cover:Pest control devicesMonitoring and maintenance of devicesPest control personnelPest control chemicalsMonitoring for effectivenessPest control recordsPest control devices: Outdoor bait station for rodents, netting trap for birds, inside station forrodents, insect lights, appropriate location for maximum effectiveness, diagram or mapindicating the location of all pest control devices.Monitoring and maintenance of pest control devices: Monitor status of the devices at aestablished frequency, Monitor pest activity, if unusual pest activity is monitored, immediateaction should be taken, If devices lost their effectiveness, they should be serviced.Pest control personnel: Identify responsibility of people involved, Qualification and trainingrequired, External pest control company may be used.Pest control chemicals: Approved chemicals only, label, storageMonitoring the effectiveness: Program effectiveness should be monitored on a continuous basis,If pest activity monitored source should be found and eliminatedPest control records: Scheduled monitoring of pest devices, Use of pesticides within the plantL1312.Why do you need to maintain an area clean if it is not regarded as a CCP?Maintaining a clean environment encourages staff to maintain cleanliness in critical areasPrevent cross-contaminationComply with codes of practice and regulationsCompany image, TQMPrevent transfer of organoleptic agents from one batch to nextEnsure efficient operation of the plant and equipment, e.g. heat transfer
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