【实用文档】Quality Audit Information Attachment
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Quality Audit Information AttachmentTable of Contents:Table of Attachments: (1)Compliance and System Modules (1)Audit Types (2)Rating of Individual Findings (2)Overall Audit Outcome (4)Compliance and System Modules – TCCQS Evolution 3Manufacturing Compliance Modules:•Previous Audit Corrective Actions•Customer and Consumer Response•Incoming Materials: CO2 (including self-manufacturing)•Incoming Materials: Sweeteners & Ingredients•Incoming Materials: Concentrate and Beverage Base•Incoming Materials: Packaging•Incoming Materials: Auxiliary•Refillable PET•Non-returnable PET self-manufacturing•Water Treatment•Syrup Manufacturing•Container Preparation•Proportioning, Carbonation and Filling•Packaged Water•Non-carbonated Beverages•Cleaning and Sanitizing•Microbiological Program•Good Manufacturing Practices•Full Goods Handling and Storage•Hazard Analysis and Critical Control Point (HACCP) Methodology•Beverage Performance Standards•Fountain ManufacturingCold Drink Operation Compliance Modules:•New Outlet / Product Introduction•Field Maintenance and Servicing•In-House Activities (including equipment approval, refurbishing and repairs, etc.)•Quality Monitoring Module (including Vended Beverages)•Customer Relations Module (including customer satisfaction, training, incident management) •CO2, Cylinder Handling and Warehousing•Hazard Analysis and Critical Control PointsSystem Modules:•Goals and Objectives•Management Responsibility•Documentation•Records•Material and Product Integrity•Process Integrity•Design and Development•Commercialization•Calibration•Incident Management and Crisis Resolution (IMCR)•Audit•Consumer Responsibility and Customer Satisfaction•Continuous ImprovementAudit TypesQuality Audit Type will be dependant on the Operation maturity system development and the level of compliance to The Coca-Cola Quality System (TCCQS):Notes:1. Number of auditors and audit duration may change depending on the circumstances.2. Mfg = Manufacturing Operation3. CDO = Cold Drink Operation: organizational unit with responsibility for distributing, sellingfountain products, and/or servicing and maintaining fountain equipment, vendors, coolers,water dispensers.4. Compliance Modules – set of specific standards and process parameters unique to TCCQS,e.g. quality control programs, water treatment requirements, syrup specifications, etc.5. System Elements – system requirements provided by TCCQS, e.g. managementresponsibility, document control, record keeping, internal audit, corrective actions, etc.6. Certification is a recognition given by The Coca-Cola Company as a result of the audit thatverifies Franchise Bottling Operation meeting the standards of The Coca-Cola Quality System applicable to the scope of the assessment and implementation phase.Previously called Phase III of the Certification Program.Rating of Individual FindingsThe following categories are applicable to individual findings:➢Improvement Opportunity➢Potential Risk➢High Risk➢Critical Risk➢StrengthImprovement Opportunity➢Any low impact finding (isolated or systematic), which is not a structural shortcoming to a quality system element.➢Any issue where there is no evidence of bad results, but where the system does not provide enough guarantee for consistent effective performance.➢Any situation where the current system meets the requirements of TCCQS but there is an important opportunity for efficiency improvementA number of Improvement Opportunities, when reviewed collectively, may present a Potential Risk to the operation. In these instances, the audit team may deem it appropriate to present these collective Improvement Opportunities as a Potential Risk finding.The finding should be included in the Corrective Action Program of the operation.Potential Risk➢Any finding that has a current or potential high impact on quality (the finding can be isolated or systematic).➢Any structural shortcoming in a Quality System element.The business risk to the Company or the operation is currently not significant.A number of Potential Risk findings, when reviewed collectively, may present a High Risk to the operation. In these instances, the audit team may deem it appropriate to present these collective Potential Risks as a High Risk finding.Corrective action should be included as a p riority within the operation’s on-going activities.High RiskAny finding or structural shortcoming in the Quality System that could:➢Create a health and/or safety concern, and/or➢Result in public relations embarrassment thereby putting The Company’s integrity or reputation at risk, and/or➢Reduce current or future sales, and/or➢Reduce the financial results of the operationThe business risk to the Company or the operation is high.Items are ranked as High Risk if, on further investigation, it is found that either the preventative or detective controls are inadequate.A number of High Risk findings, when reviewed collectively, may present a Critical Risk to the operation. In these instances, the audit team may deem it appropriate to present these collective High Risks as a Critical Risk finding.Corrective action needs to be i nitiated immediately as part of the operation’s ongoing activities.Critical RiskAny finding or structural shortcoming in the Quality System that could:➢Create a major health and/or safety concern, requiring production to be stopped immediately and market place actions initiated, and/or➢Result in a major public relations embarrassment or regulatory intervention, thereby creating a severe risk for The Co mpany’s integrity or reputation, a nd/or➢Significantly reduce or eliminate current or future sales, and/or➢Significantly reduce or eliminate the financial results of the operationThe business risk to the Company or the operation is critical.Items are ranked as Critical Risk if, on further investigation, it is found that both the preventative and detective controls are inadequate.Corrective action needs to be initiated immediately and completed before operational activities may be restarted.StrengthA successful practice that needs to be shared with other operations (any program, procedure, activity or technical solution that the auditors have found to produce consistent satisfactory results well above the level required in TCCQS).Overall Audit OutcomeThe Overall Audit Outcome is expressed in a statement that represents the Operation’s status of System development and/or meeting Compliance requirements of TCCQS. The statement corresponds to one of the following categories:Typical areas of focus for the Overall Audit Outcome are subject to Audit Type:The following criteria are used for the Overall Audit Outcome of the Operation:➢Number and severity of individual audit findings➢Any number of Critical Risks or High Risks will fail the audit➢Quality System characteristics, as applicable to the Audit Type (see table above)➢Assessment of Effectiveness will include the audit result, as well as, the Quality Measures results and other Key Performance Indicators (KPI)➢Surveillance Audits (applicable to previously Certified operations) are based on sampling of processes and System Elements and are focused on continuous improvement.。