QUALITY MANAGEMENT SYSTEM

FOOD INDUSTRY
ISO 9001:2000 Product System Certification Gap Assessment Analysis Report

Contact: Mr. Franck Ardourel Quality Six Sigma Consultant

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Report Lay Out

This report is based on the Internal Audit Checklist that will be used to conduct all your internal audits. Basically we are addressing each question and identifying the necessary documentation that is needed to address the requirement. My response to each question is formatted in Blue Text and the Yellow highlights identify the necessary document to address the requirement. At the end of each section I will give an overview that will be identifying additional action items, such as implementation and training.

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ISO 9001 / ISO 9001:2000 Gap Assessment Checklist

Section 4: Quality Management System
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

General requirements - Is there evidence that the processes needed for the quality management system have been identified and applied throughout the organization? 1. Does the organization have a documented quality management system? 2. Does it meet the requirements of the ISO 9001:2000 International Standard? ISO 9000 4.1a

1.

At this time there is a documented quality management system if the form of Drafted Quality Manual dates April 14, 2004. My assessment of this manual and the deficiencies are documented in detail in the appropriate sections of this document. The manual is drafted in accordance with the requirements of the ISO standard. My assessment and the deficiencies are document in detail in the appropriate sections of this document.

2.

General requirements - Has the organization determined the sequence and interrelation of the quality management system processes? 1. ISO 9000 4.1b How and where are processes and their interaction defined?

1.

Section 4 of the Drafted quality manual states that Java has identified the necessary processes, but it does not make reference to the processes. What is needed is an appendix to the quality manual that identifies the processes from determining the customer requirements to delivery of the finished goods. This chart will be titled Process Interrelation Flow Chart.

General requirements - Has the organization determined the criteria and methods needed to ensure that both the operation and control of the quality management system processes are effective? 1. How and where has the organization determined the criteria and methods needed to make sure that the processes are carried out as required and are implemented effectively?

ISO 9000 4.1c

1.

The process we will utilize to determine the criteria and methods needed to make sure that the processes are effective will be the documented SOPs, Work Instructions and forms. We will identify all the necessary documentation within our QMS on a Document Master List. This list will be referenced in (section 4) of the Quality Manual identifying our determination of the methods.

General requirements - Does the organization have the resources available and the information necessary to support the operation and monitoring of these processes? 1. ISO 9000 4.1d How does management ensure that the required resources are available?

1.

In the Quality Manual (section 4) we will state that resources are reviewed daily for the production processes (i.e. personnel, raw materials, scheduling, etc) In addition to this review, a higher level review of equipment, work environment, building, etc... Will be conducted during the management review meeting.

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ISO 9001 / ISO 9001:2000 Gap Assessment Checklist

Section 4: Quality Management System
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

General requirements - Does the organization monitor, measure, and analyze the quality management system processes? 1. ISO 9000 4.1e How does the organization monitor, measure and analyze the quality management system processes?

1.

In section 4 of the Quality Manual we will make reference to our Quality Objectives (Process Improvement Targets) as the chosen method to monitor measure and analyze the QMS processes. These objectives and targets will be reviewed and analyzed during each management review meeting.

General requirements - Has the organization implemented actions necessary to achieve planned results and continual improvement of the ISO 9001:2000 quality management system processes? 1. ISO 9000 4.1f How does management use the process approach to effectively control processes and achieve continual improvement?

1.

The above-mentioned Quality Objectives (Process Improvement Targets) are used to provide evidence of the process approach. This again will be stated in section 4 of the Quality Manual.

1. If the organization outsources any process that affects product conformity with requirements, how does the organization ensure control over these processes? ISO 9000 4.1

1.

In section 4 of the Quality Manual we will make reference to our Purchasing Procedures as the chosen method to control all outsourced processes. During the assessment I did not identify any process that Java outsourced, but we will make the statement in the manual just in case we need to outsource some processes in the future.
Does the quality system documentation include documented statements of a quality policy and quality objectives?

1. ISO 9000 4.2.1a

1.

Quality Manual draft does make reference to the President and Senior Management generation of a quality policy, but the policy was not reviewed during this assessment. We will want to include the quality policy as either an attachment to the Quality Manual or a separated document. If a separate document then we will need to make the reference in the quality manual.

1. Documentation requirements - Does the quality system documentation include a quality manual? ISO 9000 4.2.1b

1.

At this time there is a drafted quality manual dated 4-14-04. This manual does address each requirement of the ISO standard. My additions to the manual are documented in the appropriate sections of this report.

1. Does the quality system documentation include documented procedures required by the standard?

1.
ISO 9000 4.2.1c

In section 4 paragraph 3 there is a reference of the Quality and Safety Assurance Procedures, Document Control Procedure and the Control of Records Procedure. The ISO standard also requires that we make reference to a Corrective Action Procedure, Preventive Action Procedure, Internal Audit Procedure and a Control of Nonconforming Products Procedure. We will need to document these procedures and make reference to them in the appropriate sections of the quality manual.

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ISO 9001 / ISO 9001:2000 Gap Assessment Checklist

Section 4: Quality Management System
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Does the quality system documentation include documents needed by the organization to ensure effective planning, operation, and control of its processes? 2. Where has management defined the documentation it needs to maintain the quality management system?

1.

At this time the quality system documentation is in the forms of a Quality Manual and a Procedures Manual. It is clear that these documents were drafted in accordance with the ISO requirements. Each of these procedures need to be reviewed with the department managers to modify and simplify to better fit their current processes. I also recommend that we generate process flow charts to identify their processes in a process map. The Quality Manual should better define the documentation structure. I recommend that we put the documentation pyramid that identifies the documentation structure.

2.
ISO 9000 4.2.1d

1. Documentation requirements - Does the quality system documentation include records required by the standard? ISO 9000 4.2.1e

1.

There is a records list to satisfy this requirement, but this list has not been completed at this time. We will need to have each manager identify the records within their department on this list and maintain this list within our QMS documentation.

1. Quality manual - Does the organizations quality manual include the scope of the quality management system, including details and justification for any exclusion? ISO 9000 4.2.2a

1.

At this time the drafted quality manual does identify the scope of the QMS but it does not address any exclusions. In my opinion we can exclude section 7.5.2 of the ISO standard. We should justify why we are excluding the requirement in the scope section of the quality manual.

1. Quality manual - Does the organizations quality manual include documented procedures or reference to documented procedures?

ISO 9000 4.2.2b

1. At this time the quality manual does make reference to some procedures but does not make reference to the ISO required procedures; Corrective Action Procedure, Preventive Action Procedure, Internal Audit Procedure and a Control of Nonconforming Products Procedure. These procedures need to be addressed in the quality manual.

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ISO 9001 / ISO 9001:2000 Gap Assessment Checklist

Section 4: Quality Management System
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Quality manual - Does the organizations quality manual include a description of the interaction between the processes of the quality management system? ISO 9000 4.2.2c

1.

At this time the interaction between the processes is not clearly identified in the current quality manual. We should include a process interrelation flow chart as an appendix to the manual.

1. Control of documents - Is there a documented procedure that defines the controls needed to approve the adequacy of a document prior to use?

1.
ISO 9000 4.2.3a

At this time there is a Document Control Procedure (PM 6.1) but it has yet to be implemented. I recommend that management reviews this procedure along with TRIMQUALITY so TRIMQUALITY can recommend simpler methods to control documents. Once this meeting is completed this procedure will need to be revised and implemented throughout the organization. Just a note: all blend sheets will need to be controlled with a revision status.

1. Control of documents - Is there evidence that documents of external origin are identified, their distribution is controlled, and this control is defined in a documented procedure?

ISO 9000 4.2.3f

1. At this time I do not see that external documents are addressed in the Document Control Procedure (PM 6.1). We will need to identify the controls for external documents in this procedure. I suggest that we generate a External document List and identify external documents such as ISO 9001:2000 requirements ,AIB Consolidated Standards U.S. Federal Food Drug and Cosmetic Act (1938); Good Manufacturing Practices, CFR Title 21, Part 110 (1986); U.S. Military Sanitary Standards; the U.S. Federal Insecticide, Fungicide, and Rodenticide Act; EC Directive 93/43/EEC; UK Food Safety (General Food Hygiene) Regulations 1995 (1995/1763); The UK Food Safety (Temperature Control) Regulations 1995; and Codex Alimentarius Commission Food Hygiene - Basic Texts (1999).
1. Control of records What evidence exists that quality records are established and maintained to provide evidence of the effective operation of the QMS?

ISO 9000 4.2.4

1.

At this time there is a procedure for control of records Control of Records (PM6.2). This procedure has yet to be implemented. We will need to work with each department manager to identify records within their department on the Records List. SECTOIN 4 SUMMARY

With revision to the Quality Manual, Document Control Procedure and the Control of Records Procedure we will meet the ISO requirements from a document standpoint. We will then need to train the appropriate employees and then implement in accordance with the documents. Department managers are going to need to work with TRIMQUALITY to assist in documenting the above processes to both meet the ISO requirements and to work efficiently for the Java processes.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 5: Management Responsibility
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Management commitment What evidence exists of top managements commitment to the development and implementation of the QMS and continually improving its effectiveness?

1.
ISO 9000 5.1

Executive management will need to show their commitment to the QMS by their involvement in the management review process, corrective action process and the preventive action process. We will also need their involvement in generating and reviewing the quality manual, quality policy and the quality objectives.

1. Management commitment What evidence exists that top management communicates to the organization the importance of meeting customer, statutory, and regulatory requirements? ISO 9000 5.1a

1.

The best way to approach this communication element is to simply include this commitment in the Quality Policy, then communicate the policy to all employees. In addition I believe we should post the minutes from the management review meeting so that all employees are aware of the status of the QMS.

1. Management commitment - What evidence exists to demonstrate top managements commitment to the development and implementation of the QMS through establishment of the quality policy? ISO 9000 5.1b

1.

At this time the methods used for establishing managements commitment is documented in the drafted quality manual section 5 paragraph 1. We will need to train the executive management on this section of the manual and ensure that they are aware of there roles and responsibilities within the QMS.

1. Management commitment - What evidence exists of top managements commitment to the development and implementation of the QMS by ensuring that quality objectives are established?

1.
ISO 9000 5.1c

There are objectives documented in Section 5 paragraph 4, but these objectives are not measurable. Each objective needs to have a target identified and the method used to track the data towards the target. These objectives will need to be reviewed during each management review meeting to identify the status towards the target.

1. Management commitment - What evidence exists of top managements commitment to the development and implementation of the QMS by conducting management reviews?

1.
ISO 9000 5.1d

At this time the quality manual states that management reviews are conducted at planned intervals, but the intervals are not identified. We will need to management to systematically to conduct management reviews in accordance with section 5.6 of this report.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 5: Management Responsibility
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Management commitment - What evidence exists of top managements commitment to the development and implementation of the QMS by ensuring the availability of resources? ISO 9000 5.1e

1.

Management will need to review QMS resources during each management review meetings, and then provide those necessary resources. We will need to document this review process in section 5 of the quality manual.

1. Customer focus - What evidence exists that top management ensures that customer requirements are determined and met with the aim of enhancing customer satisfaction? ISO 9000 5.2

1.

Customer requirements are determined during the contract review (sales) process; we will need to make reference to the contract review procedure in section 5 of the quality manual.

1. Quality policy What evidence exists that the quality policy is appropriate for the organization and includes a commitment to comply with requirements and continually improve the effectiveness of the QMS?

1.
ISO 9000 5.3a-b

At this time the Quality Policy is not present within the current set of documents that I reviewed. We will need to work with the executive management team to generate a quality policy. This policy will need to be embedded in the quality manual or referenced within the quality manual.

1. Quality policy What evidence exists that the quality policy provides a framework for reviewing and establishing quality objectives, is communicated and understood within the organization, and is reviewed for continuing suitability?

1.
ISO 9000 5.3c-e

In the quality policy we will include our commitment to documenting and reviewing quality objectives.

1. Quality objectives What evidence exists that top management has established quality objectives at relevant functions within the organization, and that they are measurable, and consistent with the quality policy?

ISO 9000 5.4.1

1.

At this time the objectives are documented in section 5 paragraph 4 of the quality manual. The Executive Management Team will need to review and approve these objectives. In addition to this review we will need to identify targets for these objectives so we can make them measurable. In addition to the documented quality objectives in your draft quality manual we will need to include the objectives and targets from the Improvement Initiative report.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 5: Management Responsibility
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Quality management system planning What evidence exists that the planning of the QMS is carried out in order to meet the requirements given in 4.1 and the quality objectives? ISO 9000 5.4.2a

1.

In the Quality Manual we will identify that quality objectives are reviewed and planned for during each management review meeting.

1. Quality management system planning What evidence exists that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? ISO 9000 5.4.2b

1.

In section 5 paragraph 4 we will include the statement that management ensures the integrity of the QMS by managing all changes to the QMS through the Document Control Process.

1. Responsibility and authority - What evidence exists that top management has ensured that responsibilities and authorities are defined and communicated within the organization?

ISO 9000 5.5.1

1.

Section 5 paragraph 5.1 identifies the responsibilities of the management team, the Organizational chart identifies authority. These responsibilities will need to be reviewed and approved by the management team when the Quality Manual is released.

1. Management representative What evidence exists that top management has appointed a member of management who has the responsibility and authority to ensure that processes needed for the QMS are established, implemented, and maintained? ISO 9000 5.5.2a

1.

Section 5 paragraph 5.2 states that the QA Specialist has been assigned the responsibilities of Management Representative. This too will need to be reviewed and approved by the executive management team when the Quality Manual is released.

1. Management representative What evidence exists that this individual is reporting to top management on the performance of the QMS and any need for improvement?

ISO 9000 5.5.2b

1.

Section 5 paragraph 5.2 identifies the responsibilities of the Management Representative, within these responsibilities it is documented reporting to the Managing Director on the performance of the QMS. I believe that this should be revised to report to the executive management team. The Management Representative needs to have the authority to report directly to the top management team.

1. Management representative What evidence exists that the Management Representative promotes the awareness of customer requirements throughout the organization? ISO 9000 5.5.2c

1.

Again this responsibility is documented in Section 5 paragraph 5.2 to promote the awareness of customer requirements. The way this promotion should take place is by having a quality objective tied directly into our customer satisfaction, then post the status of this objective so that each employee has visibility to the data.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 5: Management Responsibility
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Internal communication What evidence exists that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS? ISO 9000 5.5.3

1.

Section 5 paragraph 5.3 of the quality manual states that management meetings, departmental meetings, staff communication meetings, site e-mails and notice boards are the forms of internal communication. Java will need to ensure that these forms of communication are implemented.

1. Organization Performance Feedback What evidence exists that employees are informed of the organizations quality performance and level of customer satisfaction? ISO 9001:2000 5.5.3.C.1

1.

Section 5 paragraph 5.3 of the quality manual states that the QA Specialist is responsible for informing employees on the performance of the QMS. It does not identify how this is done, I suggest that we document in this section of the quality manual that this is done by posting the data analysis results for the quality objectives on the notice boards.

1. Management review What evidence exists that top management reviews the QMS at defined intervals to ensure continued suitability, adequacy, and effectiveness? ISO 9000 5.6.1

1.

The Management Review Procedure (PM 6.6) addresses this requirement. Executive management will need to review and approve this document. Then they will need to perform this management review as defined in the procedure. My only recommendation is that the intervals by a minimum semi-annually.

1. Management review What evidence exists that management reviews include assigning opportunities for improvement, and the need for change to the QMS, including the quality policy and quality objectives? ISO 9000 5.6.1

1.

All these are identified as management review agenda items in the Management Review Procedure (PM 6.6). Management will need to include each item in the agenda for their Management Review Meetings.

Section 5 Summary It is very important that executive management understands and implements this section of the quality manual. Executive Management will be responsible conducting systematic management review meetings and maintaining minutes and action items of these meetings. TRIMQUALITY will conduct the first management review meeting to ensure that it complies with the ISO requirements. Java can then use this meeting as a template for future meetings. Management will need to ensure that the Notice Boards are implemented and that management review minutes and data analysis reports are posted there to communicate to all employees the status of the QMS.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 6: Resource Management
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Resource Management, Provision of resources What evidence exists that the organization has determined and provides the resources needed to implement and maintain the QMS and continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements?

1.
ISO 9000 6.1a-b

Section 6 paragraph 1 states that the resources are reviewed but does not identify the process of reviewing these resources. I suggest that we document in this section of the quality manual that resources are reviewed during each management review meeting.

1. Human resources, General What evidence exists that personnel performing work affecting quality are competent on the basis of appropriate education, training, skills, and experience?

1.
ISO 9000 6.2.1

Training Procedure (PM 6.5) addresses all the needs in order to comply with the ISO requirements. This procedure needs to be implemented by each dept. manager by documenting their annual training plan and training their employees according to the plan. Dept. Managers will need to maintain records of the employee training. The Training Plans will need to include all the QMS documents that we generate during our ISO project. I also reviewed the Production Training Plan, I am not sure that this entire document has been implemented. I believe that we should implement throughout the facility.

2.

1. Competence, awareness, and training - What evidence exists that the organization determines the necessary competence for personnel performing work affecting quality? ISO 9000 6.2.2a

1.

Once the Training Plan is implemented throughout each department this requirement will be met. By identifying the necessary training needs on the Training Plan we will be determining the necessary competence.

1. Competence, awareness, and training - What evidence exists that the organization has provided training or taken other actions to satisfy competence, awareness, and training needs, and that the organization has evaluated the effectiveness of the actions taken? ISO 9000 6.2.2b-c

1.

Department Managers will need to retain training records for EVERY employee in their department as training is provided to them.

1. Competence, awareness, and training - What evidence exists that the organization has ensured that its personnel are aware of the relevance and importance of their activities, and how they contribute to the achievement of quality objectives? ISO 9000 6.2.2d

1.

As part of the induction training documented in the Training Procedure (PM 6.5) section 4.4 we need to generate an Introduction to ISO training presentation. This will inform all employees on their importance and relevance to the QMS.

Competence, awareness, and training What evidence exists that the organization maintains appropriate records of education, training, skills, and experience? ISO 9000 6.2.2.e

1. Department Managers will need to retain employee training records as the training is provided.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 6: Resource Management
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Infrastructure What evidence exists that the organization has determined, provided, and maintains an infrastructure to achieve conformity to product requirements? This includes buildings, workspace and associated utilities, process equipment (hardware and software), and support services (transport and communication).

1.
ISO 9000 6.3a-c

The production department is going to need to implement a preventive maintenance program for the equipment used in the production environment. This program needs to be documented to include the intervals for the equipment inspections and the necessary inspection items. In addition to the above maintenance program, the IT dept. is going to need to document there process of network security and backup procedure. This too needs to identify intervals and the process of ensuring that the data is protected in case of building destruction. (Store offsite). During each internal audit the auditors will need to evaluate the building and workspace to be able to report to executive management on their perspective as to the adequacy of the facility.

2.

3.

1. Work environment What evidence exists that the organization manages the work environment in order to achieve conformity to product requirements? ISO 9000 6.4

1.

With section 6 of the quality manual and the related procedures this requirement is addressed. We will need to implement these procedures prior to ISO registration.

Section 6 Summary To address this requirement we have to document and implement a training program. Each dept. manager will need to implement the training program and document all employee training on the appropriate training forms. TRIMQUALITY will need to work with the production department to document the maintenance program. This program needs to be complete with the equipment checklist and schedules. Machine operators will then need to systematically inspect the equipment and complete the checklist in accordance with the procedure. The IT department is going to need to work with TRIMQUALITY in documenting the IT security and backup process. These tapes will need to be secured periodically at an off-site facility. The internal auditors will need to be trained to complete a facility inspection to be able to report to management on the status of the facility.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 7: Product Realization
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Planning of product realization What evidence exists that the organization has determined quality objectives and requirements for the product?

ISO 9000 7.1a

1.

The current Quality Manual (section 6 paragraph 1.1) states that the following documents are in place; Process Flow Diagram, Quality Plan and a Product Specifications. Once we generate the Process Flow Diagrams for each department and implement these documents we can comply with this requirement.

1. Planning of product realization What evidence exists that the organization has determined processes, documents, and resources specific to a product?

ISO 9000 7.1b

1. Once the document control process is in place and the List of Documents is in place, we will use this list to identify the necessary documents and processes within our QMS. We will need to identify all production related documents on this list such as: blend sheets and instructions.
1. Planning of product realization What evidence exists that the organization has established verification, monitoring, inspection, and test activities for specific product and established the criteria for product acceptance?

ISO 9000 7.1c

1.

The inspection process from receiving inspection to final product testing is very well implemented. This process needs to be documented in an inspection flow chart.

1. Planning of product realization What evidence exists that the organization has records needed to provide evidence that the realization process and resulting product meet requirements? ISO 9000 7.1d

1.

For each inspection we will need to have a record for that inspection. Keep in mind this is true for receiving inspection and taste sampling as well as all in-process inspections.

1. Determination of requirements related to the product Describe the evidence demonstrating that the organization has determined the requirements specified by the customer (including requirements for delivery and post-delivery activity), and requirements not stated by the customer, but necessary for specified or intended use, where known. ISO 9000 7.2.1a-b

1.

Section 1 of the Procedures Manual addresses, what appears to be, all different avenues of how sales come into Java City, with the exception of internet sales, this too needs to be documented in this procedure. I also recommend that we map out these processes in a form of a flow chart.

1. Determination of requirements related to the product Describe the evidence demonstrating that the organization has determined the statutory and regulatory requirements related to the product, and any additional requirements determined by the organization. ISO 9000 7.2.1c-d

1. Implement Section 1 of the Procedures Manual to address this requirement.

1. Review of requirements related to the product Describe any evidence demonstrating that the organization reviews the requirements related to the product prior to the commitment to supply the product.

ISO 9000 7.2.2

1. Implement Section 1 of the Procedures Manual to address this requirement.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 7: Product Realization
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Customer communication Describe the evidence demonstrating how the organization determines and implements effective arrangements for communicating with customers in relation to product information, enquiries, contracts or order handling (including amendments). ISO 9000 7.2.3a-b

1.

Section 7 paragraph 2.3 addresses this requirement. The customer service department and the sales department will need to implement this communication practice.

1. Design and Development inputs How are inputs related to product requirements determined and recorded? Do the inputs include: a) functional and performance requirements, b) any applicable statutory and regulatory requirements, c) information derived from previous similar designs, and d) other requirements essential for design and development? ISO 9000 7.3.2 a-d

1.

To address the design requirements of the ISO standard. TRIMQUALITY and the New Product Development Department will need to review procedures PM 1.2.1 and PM 1.2.2. Based on this review we will make the necessary revisions so that the NPI process meets the ISO requirements and is effective and efficient for Java City.

1. Purchasing process - Describe the evidence demonstrating that purchased product conforms to specified requirements.

1.
ISO 9000 7.4.1

To address the vendor management and purchasing requirements of the ISO standard, TRIMQUALITY will need to review section 2 of the procedures manual with all departments that have purchasing responsibilities. Based on this review we will make the necessary revisions so that the NPI process meets the ISO requirements and is effective and efficient for Java City.

1. Verification of purchased products Describe the evidence demonstrating that inspection or other activities have been implemented to ensure that purchased product meets specified purchase requirements. ISO 9000 7.4.3 1.

Section 3 of the procedures manual addresses the ISO requirements, the only thing that is missing is that the procedure does not define the process of sampling and receiving coffee beans. This procedure needs to be reviewed with the responsible departments for receiving and inspection and modified to better fit the processes at Java City. We will also need to include the coffee beans process in this procedure.

1. Control of production and service provision Describe the evidence demonstrating that the organization plans and carries out production and service provision under controlled conditions that shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, c) and the use of suitable equipment. ISO 9000 7.5.1a-c

1.

All of the documents that we will be generating and listing on our Document List will be the documents needed to control the production process. We will be including the blend sheets in these documents.

1. Identification and traceability Describe the evidence demonstrating that the organization has identified the product by suitable means throughout product realization. Has the organization identified the product status with respect to monitoring and measurement requirements? Where traceability is a requirement, does the organization control and record the unique identification of the product? ISO 9000 7.5.3

1.

Section 3 paragraph 3.1 thru 3.5 of the Procedural Manual address the material identification and traceability element. This document will need to be reviewed by TRIMQUALITY and the Material Handling departments. Based on this review this procedure may be modified to better fit the operations at Java City.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 7: Product Realization
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Customer property Describe the evidence demonstrating that the organization exercises care with customer property while it is under the organization's control or being used by the organization. The evidence must support that the organization identifies, verifies, protects, and safeguards customer property provided for use or incorporation into the product. NOTE: Customer property can include intellectual property. ISO 9000 7.5.4

1.

Java City does not handle any customer property; therefore we will give justification for excluding this requirement.

1. Control of monitoring and measuring devices Describe the evidence demonstrating that the organization has determined the monitoring and measurements to be undertaken, and the monitoring and measuring devices needed to provide evidence of conformity of product. ISO 9000 7.6

1.

PM 6.8 of the Procedural Manual addresses the Calibration requirement. We will need to review and implement this section of the manual.

Section 7 Summary To address the requirements of this section we basically need to review and possibly generate process maps for all the processes, from generating customer orders to product shipment. The documents will then need to be reviewed and approved by the process owners. We will then train the department employees on the documents and let them implement them. Process owners from Java City will need to be prepared to meet with TRIMQUALITY and conduct document review and revisions.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 8: Measurement, Analysis and Improvement
ISO 9001:2000 / ISO Standard Clause 1.

REQUIREMENT

Measurement, analysis and improvement Describe the evidence demonstrating that the organization has planned and implemented the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity of the product, b) to ensure conformity of the quality management system, and, c) to continually improve the effectiveness of the quality management system.

ISO 9000 8.1a-c

1.

In section 8 in paragraph 1 of the quality manual we will tie in the management review meeting to address the measurement, analysis and improvement aspect of the requirement. During each management review meeting we will review and analyze the data from the quality objectives and document the discussion in the meeting minutes and action items.

1. Customer satisfaction Describe the evidence that as one of the measurements of the performance of the quality management system, the organization monitors information relating to customer perception as to whether the organization has met customer requirements. ISO 9000 8.2.1

1.

In section 8 paragraph 2.1 it states that customer satisfaction is measured customer complaint analysis and consumer research surveys. We will need to establish quality objectives around these two methods and again analyze the data during the management review meeting.

1. Internal audit Describe how the organization conducts internal audits at planned intervals to determine whether the quality management system, a) conforms to the planned arrangements, to the requirements of this International Standard and to the quality management system requirements established by the organization, and, b) is effectively implemented and maintained. ISO 9000 8.2.2

1. 2.

TRIMQUALITY will conduct the first internal audit and supply all the necessary tools and training to the selected (by Java executive management) internal auditors. Java will then need to systematically conduct the internal audits in accordance with the Internal Audit Procedure.

ISO 9000 8.2.3

1. Monitoring and measurement of processes Describe the evidence that the organization has applied suitable methods for monitoring and, where applicable, measurement of the quality management system processes. How do these methods demonstrate the ability of the processes to achieve planned results? When planned results are not achieved, how are correction and corrective action taken, as appropriate, to ensure conformity of the product?

1.

Section 8 paragraphs 2.3 makes reference to the internal inspection process as a way to monitor and measure processes. This is sufficient to meet the ISO requirement.

ISO 9000 8.2.4

1. Monitoring and measurement of product Describe the evidence that the organization monitors and measures the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product. Product release and service delivery shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

1. Section 8 paragraphs 2.4 makes reference to monitoring and measurement of product, this meets the ISO requirement. But I suggest the we identify the inspection stages in a process map.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 8: Measurement, Analysis and Improvement
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

1. Control of nonconforming product Describe the evidence that the organization has ensured that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. Are the controls and related responsibilities and authorities for dealing with nonconforming product defined in a documented procedure?

1.
ISO 9000 8.3

At this time I have not viewed any procedure for Control of Nonconforming Products. We will need to identify the controls for nonconforming products in a procedure. This procedure will need to identify the responsibility for disposition of the nonconforming products. This disposition process will need to be recorded. As nonconforming products are identified they will need to be identified and/or segregated. Each employee within the company will need to be trained on this process.

1. Analysis of data Describe the evidence that the organization determines, collects, and analyses appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. Does this include data generated as a result of monitoring and measurement and from other relevant sources? ISO 9000 8.4

1.

Section 8 paragraph 4 identifies the data and process to analyze this data along with the six sigma data from the Improvement Initiative report will comply with the ISO requirement. We will just need to implement this during the first management review meeting.

1. Continual improvement Describe the evidence that the organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. ISO 9000 8.5.1

1.

Section 8 paragraph 5 meets the requirement of the ISO standard.

ISO 9000 8.5.2

1. Corrective action Describe the evidence that the organization has taken action to eliminate the cause of nonconformities in order to prevent recurrence. Are corrective actions appropriate to the effects of the nonconformities encountered? Has a documented procedure been established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and, f) reviewing corrective action taken?

1.

We need to implement the corrective action process as documented in the section 8 paragraph 5.2 of the quality manual.

1. Preventive action Describe the evidence that the organization has determined actions to eliminate the causes of potential nonconformities in order to prevent their occurrence. Are preventive actions appropriate to the effects of the potential problems? Has a documented procedure been established to define requirements for a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing preventive action taken? ISO 9000 8.5.3

1.

We need to implement the preventive action process as documented in the section 8 paragraph 5.3 of the quality manual.

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ISO 9001 / ISO 9001:2000 AUDIT CHECKLIST

Section 8: Measurement, Analysis and Improvement
ISO 9001:2000 / ISO Standard Clause

REQUIREMENT

Section 8 Summary The majority of this section is already documented in the current quality manual we will need management to review and approve the quality manual. We will then train the necessary employees on their roles and responsibilities.

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