Procedures Manual 8-31-07
Procedures Manual 8-31-07
Procedures Manual 8-31-07
Approved _Bipin
Mukherji____________
TABLE OF CONTENTS
TOPIC PAGE
Document & Data Control - 4.2.3 Control of Quality Record - 4.2.4 Management Requirement - 5.0 Customer Focus - 5.2 Quality Planning & Implementation - 5.4 Management Review - 5.6 Employee Competence, Awareness & Training - 6.22 Contract Review - 7.2.1 Purchasing - 7.4 Product Identification & Traceability - 7.5.3 Control of Customer Supplied Product- 7.5.4 Handling, Storage, Packaging, Preservation, & Delivery - 7.5.5 Control of Inspection, Measuring & Test Equipment - 7.6 Test & Inspection Methods - 8.2 Customer Satisfaction - 8.2.1 Internal Quality Audit- 8.2.2 Receiving Inspection - 8.2.4 First Article Inspection - 8.2.4.A In-Process Inspection - 8.2.4.B Final Inspection- 8.2.4.C Control of Non-Conforming Product - 8.3 Control & Customer Notification of Suspect Product 8.3.A Continual Improvement - 8.5.1 Corrective Action - 8.5.2
Page 2 of 36
TITLE: DOCUMENT AND DATA CONTROL PROCEDURE NUMBER: 4.2.3 REV: N/C DATE: 10-01-2003
PURPOSE: This procedure establishes the methods used by AML to control Documents and Data for release, retention, and distribution from customers, suppliers and AML internal, as required. This will include customer furnished electronic, computer formatted, paper documents, and digital data for any purpose in the contracted performance of AML. SCOPE: This procedure covers the control of all documents and data. DEFINITION: Not applicable. RESPONSIBILITY: The Document Control Department managed by the President or his designee will be responsible for the control of all documents and data. PROCEDURE: AML Document Control Department personnel that reports to President, will be responsible for the release, retention, distribution, accountability, revision updating, change implementation and removal of all Documents and Data, as required by purchase order requirements. These functions will be controlled by training and documented job description. Documents will be classified as Company internal control documents (those documents generated by AML), and controlled by the revision form, Customer controlled documents (those documents that are controlled by the customer such as customer Blue Prints or specifications). Customer controlled documents will be placed in the job folder upon job completion, or noted as being reference and customer controlled. Customer controlled documents will not be controlled by AML, and will be issued by revision per P.O. for each job. The control of Public documents such as industry standards, Mil-specs, Ansi, Asme, Ansqc, ISO, etc. will be per contract document service (These documents are controlled by Industry and a contract service that list the current revision level, and will supply the document.) Prior to release of any Document, the AML Quality Department will review and approve the documents. This will be done by signing or stamping a copy of the Document or the master list of documents. Master List of revisions of all documents will be maintained in either the Document Control Database, and or in the Master Log for Internal documents maintained by The Quality Department. It will be updated as required. Document Change Incorporation will be per customer and AML agreed upon timetables. All changes will be documented and agreed upon prior to release. All changes and implementation will be documented in the AML job number file. The document will then be released to the department requiring the document. The document will be reviewed, distributed, implemented (to the extent required), and maintained in a timely manner. This will be defined as review within 7 days, with distribution and implementation per customer schedule. Document Accountability: Open documents such as P.O.s, quality and customer data will remain on WIP status until all parts on the P.O. are shipped to the Customer. Closed documents will be filed by job number and treated as closed files and retained for seven years per QAP 4.2.4. Only the President, can remove documents from a closed job file, and is responsible for their return.
Page 3 of 36
4.2.3 Document & Data control continued from Page 3 of 35 Customer Affectivity points will be reviewed by AML on the contract review and documented on the work instructions, and will become effective upon the mutual agreement of date or serial number, or lot as specified by the customer in the Purchase Order. This will assure the same revision level at AML on all its internal documents as required by the customer purchase order. Obsolete Documents and Data will be promptly retrieved by the Quality control department by removing the obsolete documentation from the job file. Obsolete documents and data will be destroyed or archived per customer requirements. Obsolete documents retained for any reason will be stamped with the word obsolete or for reference, and will be controlled as needed. Changes will be implemented to all customer design media only after AML has agreed to the change release date, or if written authorization is received by AML for those contracts that have been deemed as priority by the Customer. The nature of the changes will be identified and become part of the documentation in the job folder, and where practicable will be attached to the document. AML shall maintain the record of change in the job folder for documents that are controlled and not returned to the customer. Hand amendments shall be clearly marked, initialed and dated. The new document shall be issued as soon as possible. Amendments/ Revisions: Will be reviewed and will go through the same cycle as new documents. All amendments/revisions will be initiated by Contracts and distributed as necessary. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: Not applicable. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: CONTROL OF QUALITY RECORDS PROCEDURE NUMBER: 4.2.4 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes the method used to control issue, maintain, and retain quality records at the AML facility. SCOPE: This procedure covers all departments. DEFINITION: Not applicable RESPONSIBILITY: The Quality Manager will insure the compliance to this procedure. PROCEDURE: All records that verify the integrity of AML service are kept for a minimum of seven years. Records are maintained for a prescribed time according to the applicable record retention schedule. All records are maintained (stored) in a manner to preclude deterioration. All records shall be readily available for review by AML customers or regulatory. All customer records will held in confidence and no third party may access customer information without the customers written authorization. Appropriate Controls: AML will identify and index all quality records by part number, supplier, and or customer. All quality records will be collected in storage boxes or racks and all files will be controlled and maintained by the QA department. All quality records will be reviewed for customer disposition requirements, not to be less than seven years. Calibration / Inspection Records (Attributes or Variables) Inspection records are maintained within the QA Department for all active part numbers and are filed by job number. Observations and data shall be recorded at the time they are made and be identifiable to a specific task and work order. Mistakes: Mistakes will be single-line crossed out, correct entry made, and signed or initialed by the person making correction. Electronic records shall be backed-up weekly to prevent data loss. All electronic data required to be saved will have a paper back-up, or an electronic back-up. Upon completion of all operations (i.e., either shipped to a customer or sent to stock) the record is maintained in the Quality Assurance files in accordance with the QA record retention schedule. Records Retention All Records are the property of AML and are maintained through their life cycle in a systematic manner. Pertinent Quality Records are retained (10 years) to comply with governmental, contractual or AML requirements, whichever is longer. Records retention schedules as defined and documented for each department, is maintained and audited by the QA Internal Audit procedure. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 6 of 36
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: CUSTOMER FOCUS-SERVICE TO CLIENTS PROCEDURE NUMBER: 5.2 REV: A DATE: 02-15-2005
PURPOSE: To establish a procedure for the documentation, monitoring the performance in relation to the work performed by AML. All monitoring by customer will provide confidentiality of other clients. SCOPE: This procedure applies to all customers DEFINITION: None RESPONSIBILITY: The Quality Manager will be responsible for the documentation and monitoring of the documentation, and the review. PROCEDURE: All customer purchase orders will be reviewed and contract review will be performed to ensure that the customer requirements are determined. To ensure that the customer requirements are determined and customer focus is achieved, AML will review and monitor the quality of our service by means of customer quality data (rejections, corrective actions, and returns) and will review delivery to contract due dates by AML delivery data based on the customer requirements. AML will also monitor customer complaints, feedback and communication to determine customer satisfaction, and focus. All customer complaints will be resolved and corrected, feedback and communications will be addressed, and any request by the customer of an improvement nature in satisfaction will be reviewed and addressed by the President or his designee. This will be documented and will be used as customer information for the monitoring and review process. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: None. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: QUALITY PLANNING & IMPLEMENTATION PROCEDURE NUMBER: 5.4 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes the methods used by AML Quality Assurance to implement and plan for the quality requirements and implementation of the contract or order, and the structure of the quality documentation. SCOPE: This procedure covers the Quality System and Implementation into AML Quality Documentation. There are four levels of Documentation. Level one is the Quality Manual which define the policies and objectives. The second level are the Procedures, which define how a Quality process is performed. The third level of documentation are work instructions that define the task of a particular task. Supporting documentation, records, forms, memos, etc are considered a fourth level of documentation. DEFINITION: Not applicable RESPONSIBILITY: The Quality Department will be responsible for the quality planning, quality documentation structure and department managers will be responsible for the implementation of the quality plan that affects their department. The Quality Manager will assure that quality system procedures are readily accessible to personnel who are responsible for performing work in conformance to requirements, and to customer and/or regulatory authorities representatives. PROCEDURE: AML Quality Department reviews every contract at the earliest phase of contract performance to customer purchase order requirements. Quality Policy: AML will create a Quality Policy that is relevant to their goals and expectations. The Quality Policy will be created by an executive with responsibilities to define and document those goals, and ensure that the quality policy is understood, communicated, implemented and maintained at all levels of the organization. Top management has signed the Quality Policy Statement published and displayed throughout AML. By training, and new employee orientation AML will ensure that all employees understand the Quality Policy. Roles and Responsibilities: AML will have a managerial staff headed by the president that will have the authority and resources needed to discharge their duties. The overall responsibility for the technical operations will be the responsibility of the President who shall ensure compliance to ISO9001:2000. Quality Assurance is managed by the Quality Manager who is directly responsible for ensuring the compliance with ISO9001:2000, the implementation of this Quality Manual, and is responsible for ensuring that all the Quality Requirements of the Manual and the customer's requirements are met: The Quality Manager will have the freedom and authority to: a) initiate action to prevent the occurrence of any nonconformities relating to the service, process and quality system; b) identify and record any problem relating to service, process and quality system; c) initiate, recommend or provide solutions through designated channels; d) verify the implementation; e) control further processing, delivery, or evaluation of nonconforming service until the deficiency or unsatisfactory condition has been corrected.
Page 9 of 36
RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: None. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: EMPLOYEE COMPETENCE, AWARENESS AND TRAINING PROCEDURE NUMBER: 6.2.2 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes AMLs responsibility to provide training, certification, and motivation to new and existing employees attempting to continually improve the work force skill, product performance, and services. AML shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience . SCOPE: This procedure covers all departments at AML . DEFINITION: Not applicable RESPONSIBILITY: It is the responsibility of President to establish the method, parameter or function and criteria for staff training. PROCEDURE: The method of training may be formal, informal or On-the-Job Training (OJT). All formal training programs are approved by the President and/or the Quality Manager before implementation. Each employee who performs a service, related to the customer, product and/or administration, must be required to meet minimum competence standards that can be achieved by AML training. After the training, a training record is initiated documenting the individuals upgraded skill level. All training records will be maintained in the department that the person works for, the Quality department, or in their personnel file. All specific quality tasks will be assigned on the basis of experience, education or training, and will have documented job descriptions. Training Program Formal training programs are available and may be required. Where applicable, informal programs may be developed by upper management or department managers. AML training programs are coordinated to maximize efficiency, and develop expertise in essential processes and methods. Training will be documented on the AML Training Outline Form Scheduled Agendas: All training classes (formal or informal) are documented and approved by the President. OJT is a very important aspect of the employees training and is, therefore, listed on the training record. OJT may be used for developing an employees productivity and skill until a formal or informal training program is conducted. Once an employee is scheduled for a formal or informal program the training is completed. Additional Responsibilities: Personnel proficiency is periodically assessed to determine requirements for additional training.
Page 12 of 36
6.22 Employee Competence, Awareness & Training continued from Page 12 of 35 RECORDS: AML shall maintain records of all training, experience, competence, qualifications, skills and education. All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: Not applicable. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 14 of 36
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 16 of 36
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: PRODUCT IDENTIFICATION AND TRACEABILITY PROCEDURE NUMBER: 7.5.3 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes the method used by AML to provide control for the identification of product from receipt through delivery, and throughout product life as required by customer contract. This procedure also establishes the methods and responsibilities for AML serialization and labeling of customer products, where so required by contract. SCOPE: This procedure applies to all customer product. DEFINITION: Not applicable. RESPONSIBILITY: It is the responsibility of the Quality Manager to insure compliance to this procedure. PROCEDURE: Lot Traceability: All products received from customers at AML are lot traceable. Lot traceability documents the product through all inspection processes by means of documenting all processing on the work order. Sequential Records: The AML work order sheet shall maintain sequential records for the product being inspected for traceability and in section status. Loss of Traceability: If identification or traceability is Lost, AML will process the product as nonconforming material and will notify the customer. When serial number traceability, product positive identification by design characteristics is maintained by work orders, traceability is not considered lost. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: CONTROL OF CUSTOMER SUPPLIED PRODUCT PROCEDURE NUMBER: 7.5.4 REV: A DATE: 02-15-2005
PURPOSE: This procedure defines the method used by AML in the control of customer-supplied product SCOPE: This procedure applies to all customer-supplied product. DEFINITION: Not applicable. RESPONSIBILITY: It is the responsibility of the Quality Manager to insure compliance to this procedure. PROCEDURE: Receiving Inspection: AML will verify that all customer-supplied products meet the purchase order/blue print/specification requirements by processing all customer-supplied product through the AML receiving inspection department. All customer supplied products will be inspected, and verified for conformance to customer documents. Rejections: All rejected, or customer supplied product not conforming to customer document will be documented and segregated and the customer will be promptly notified. The disposition of non-conforming customer supplied product will be made by the customer, and will be documented in writing by the customer. AML will not accept any nonconforming customer supplied product unless directed to do so by the customer in writing. Identification: Customer supplied product will be identified for all inspection operations as required. When CSP is to be used for fixturing, set-up or as gauging, it will be identified to the product and customer. Storage: AML will store and maintain all customer-supplied products in the same manner as all other AML controlled customer product. Those items requiring special storage will be stored as required, with the special conditions being addressed in the customer purchase order. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 20 of 36
TITLE: CONTROL of INSPECTION, MEASURING and TEST EQUIPMENT PROCEDURE NUMBER: 7.6 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes the methods used to control mechanical instruments that are used for inspection conducted at the AML facility. All inspection equipment used for inspection will be calibrated only by outside facilities compliant to ISO9001:2000 and ISO 17025 or Guide 25. SCOPE: This procedure applies to all inspection equipment used at AML.. DEFINITION: Not applicable. RESPONSIBILITY: It is the responsibility of the Quality Manager to insure compliance to this procedure. PROCEDURE: Frequency Control: The frequency of inspection is based on the purpose, degree of usage, equipment type, and stability. Normally, initial frequency is determined from the performance of similar equipment or by the manufacturers specifications. This is determined from histories, commercial and military guidelines, usage, and environment. Gages such as gage blocks, surface plates and master gages are usually 1 year. Thread gages are controlled by usage. Gages with movable components are usually six-month recall. These frequencies are only a guide and can be adjusted as needed when documented. Calibration Due Date: After the frequency has been established, a specific calibration on due date is established and the calibration label is attached to the equipment. Gauges too small to affix a sticker or equipment in an environment where stickers do not adhere, use an alternate method of marking (i.e., string tag on equipment or label affixed to container, or notation on calibration record). All equipment is re-calibrated by that date. Temporary Extensions: Temporary extensions of calibration intervals may be authorized under certain conditions (i.e., completion of test in progress or no usage of that equipment). The Quality Assurance Manager authorizes these extensions. and are based on favorable (in tolerance) results of past calibration. This decision is documented. In addition, the instrument must be found to be in tolerance upon calibration or an instrument discrepancy report is prepared. The extension period may be for the normal calibration interval or for shorter periods of time. All extensions are entered in the measure history database. Lengthening Intervals: Frequency intervals may be lengthened on instruments that have exhibited no out-of-tolerance conditions in 5 consecutive evaluations or as might be expected on plug or pin type gauges with minimum use. The Quality Assurance Manager approves interval adjustments. Shortening Intervals: Intervals are shortened when an out-of-tolerance condition has occurred in 2 out of 5 evaluations. Out of service conditions do not count in this calculation on (Blown fuse, broken meter, etc.). NIST Traceability: All calibration at AML will be traceable to the National Institute of Standards and Technology, or equivalent. Calibration System: Inspection and Maintenance Procedures: Each type of equipment subject to Calibration at AML has an inspection and/or Calibration procedure written which establishes the Page 21 of 36
7.6 Control of Inspection, Measuring & Test Equipment continued from Page 21 of 35 method of inspection and/or Calibration on for that type of equipment. This information is derived from sources such as instruction books, drawings or tool release and change notices. The instructions derived from manufacturers specifications need not be rewritten but may be referenced in the equipment database. The Quality Assurance Manager approves inspection procedures Disposition of Obsolete or Defective Equipment: Obsolete or defective equipment is removed from service, and placed in bonded storage. If the equipment is later reused, it is re-inspected as required per this procedure. If the equipment is beyond repair, it is permanently removed from service. If the equipment is repairable it is repaired to manufactures specification. Handling of Rejected Equipment: When, during normal calibration, controlled equipment is found to be out of tolerance or defective, the Quality Manager is notified. It is the responsibility of the Quality Manager to determine the impact on products tested with the defective equipment since the previous Initial Inspection: All new test equipment is routed to the Quality department prior to use for product acceptance. At this time the equipment is evaluated and, as required by this document, be given a control number, inspection and/or maintenance schedule and a calibration label. Equipment Recall Database: This database maintains a record of the items that are to be controlled by this procedure. The database is accessed monthly by QA to identify the equipment due for calibration. QA then retrieves the equipment for calibration. Product Recall: When a measuring device is found to be out of calibration, an evaluation by the QA Manager will take place to determine whether the result may be nonconforming product. If so, the product is recalled by issuing a letter with all the pertinent information to the customer, and arraignments made to reinspect the product. Calibration Techniques: AML will use in-house calibration procedures to calibrate each measuring device. The procedure will be based on manufacturers specifications, and will include visual, dimensional and operational inspection. Calibration Label: Upon completion of calibration and providing the equipment is found satisfactory, it is tagged with a calibration label. This label indicates the calibration date and the due date of the next inspection. This label is stamped or initialed by the person performing the calibration. Equipment Identification: Each piece of equipment that is used for qualitative measurement is controlled in accordance with this procedure and identified with an asset number. Small hand instruments and tools can be marked by acceptable best methods. When it is impractical to apply labels to the equipment (such as pin gauges) they may be applied to the container. Control Records Maintained: Measure History Database: The history database is maintained by recording the transactions of the equipment listed in the equipment database. Calibration on Data Sheet: During the calibration of certain pieces of equipment, a calibration data sheet may be filled out if required. The intended purpose of this data sheet is to establish the necessary corrections to be used when using this equipment. The calibration data sheets may be placed with the equipment to which it pertains.
Page 22 of 36
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: TEST AND INSPECTION METHODS PROCEDURE NUMBER: 8.2 REV: A DATE: 02-15-2005
PURPOSE: To establish a procedure for the control of inspection methods and their validation at AML. SCOPE: This procedure applies to any and all product inspected at AML DEFINITION: RESPONSIBILITY: The President or his designee.will be responsible for all requirements of this procedure. PROCEDURE: The inspection and/or tests will be performed per work instructions created from the customers design data, purchase order requirements, and the contract review. No standard industry procedures exist, so all work will be unique. All technicians, inspectors will be trained or have verifiable experience in the use of CMMs. All set-ups must be verified by the technician or the Quality manager, and all results will be reviewed prior to submittal to the customer. AML will not perform non-standard inspection, calibration or testing. AML will not perform work outside their intended scope. Control of Data: All data is reviewed for correctness, calculations and errors of omissions and transposition by the president or his designee. Computers and software are off the shelf products. Computer data is password protected, and no customer data is transmitted to a third party without written customer authorization. All computers are properly protected and maintained in office environment to ensure proper functioning. RECORDS: Inspection and test records shall show actual inspection and test result data when requires by specification or acceptance plan. Where required to demonstrate product qualification AML shall ensure that quality records provide evidence that the product meets the defined requirements. All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: INTERNAL QUALITY AUDIT PROCEDURE NUMBER: 8.2.2 REV: A DATE: 02-15-2005
PURPOSE: The purpose of this procedure is to establish an audit function that evaluates the effectiveness of AMLS quality system. This includes, but is not limited to, the quality system (all elements of ISO9001:2000 and ISO 17025 as a minimum), Management control, quality control and workmanship of AML products. SCOPE: All quality operations and documentation, including procedures, inspections, training, process controls and certifications performed in each area within the AML facility are audited at least once per year using AML Audit forms maintained by the QA Manager. DEFINITION: Not applicable. RESPONSIBILITY: The Quality Manager will insure the compliance to this procedure. PROCEDURE: When findings cast doubt on operations or validity of results, AML shall take corrective action (per section 4.2.4) and notify clients in writing if investigations show results may have been affected. Follow-up activity shall verify and record implementation and effectiveness of the corrective action. Audit Schedule: Each procedure is audited a minimum of once every 12 months. A minimum audit schedule and the qualified auditors list serve as a guide to management in scheduling audits The audit schedule is also based on the status of importance of the activity to be audited. Personnel Qualifications: Personnel are selected for auditing assignments based on experience or training that establishes their qualifications are adequate regarding the activities to be audited. Audits are carried out by personnel independent of those having direct responsibility for the activity audited. Trained contract auditors may meet the requirement of this section. Detailed Check sheets: Detail internal check sheets will be developed for the working level procedures. The detailed check sheet will incorporate all the requirements of the procedure. The detail check sheets will be developed by QA or the controlling department. All detail check sheets will be revision controlled per section 4.2.4, and the masters will be maintained in the QA office. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: Not applicable. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: FIRST ARTICLE INSPECTION PROCEDURE NUMBER: 8.2.4 A REV: A DATE: 02-15-2005
PURPOSE: To establish a procedure for the first article functions at AML. SCOPE: This procedure applies to all parts inspected at AML. DEFINITION: First Article: a verification of the initial set-up or inspection technique prior to completion of inspection.. RESPONSIBILITY: The Quality Manager or his designee. PROCEDURE: The Quality inspector, Setup-man or a person designated by the President and with the approval of the Quality department will inspect the initial set-up or the probe check prior to completion of inspection to assure that the set-up and CMM system is acceptable for continuation of the inspection process. UNACCEPTABLE FIRST ARTICLE: When the set-up or probe check is unacceptable, the inspector will re-verify the inspection equipment calibration, the probe check for acceptability, and will re-verify the setup to the design data for acceptable datums, set-up, and/or inspection technique. If the re-verification corrects the unacceptable condition the part will be inspected. If the re-verification does not correct the unacceptable condition, the inspector will notify management, and a determination as to the inspection method/ set-up, disposition will be made, and the part will be re-set-up, transferred to another CMM, or removed and held in a non inspection status until a determination can be made by the Quality Manager as to the next step to be taken. All re-set-up will be made as noted in section 5.0 and this section (5.1). RECORDS: Inspection and test records shall show actual inspection and test result data. All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: ISO 9001-2000. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: CONTROL OF NONCONFORMING WORK PROCEDURE NUMBER: 8.3 REV: A DATE: 02-15-2005
PURPOSE: This procedure establishes the method of review, control and corrective action of nonconforming work. SCOPE: This procedure applies to all departments. DEFINITION: Not applicable. RESPONSIBILITY: It is the responsibility of the Quality Manager to insure compliance to this procedure. PROCEDURE: Work that is nonconforming will be identified and dispositioned by the AML Quality Manager. Work that is nonconforming through the actions of AML will be reworked, corrected and dispositioned per the Corrective Action Procedure.. Initial Handling of Nonconforming Work Quality Control Department: NCW are processed per the following steps: NCW is segregated from the conforming work, and prevented from unintentional use by being tagged, bonded or identified as NCW. A NCW Document is initiated by Quality personnel to document the nonconformance. It includes the following information: date, description, discrepancy, job number, and other customer required data. The Quality Manager will review the nonconformance for significance. Significance will be rated as follows: 1) Needs complete rework of the entire job and all documentation. 2) Rework of only a portion of the job. 3) Rework of only the data. 4) No rework needed, only correction of the data. 5) No corrections of any kind, just review for future improvement. If work needs to be recalled, it will be recalled using the Customer Notification Form. The Quality Manager or the President are the only employees authorized to allow for the resumption of work after the nonconformance has been corrected. Items # 1-4 above will require documented and formal corrective action per Corrective Action Procedure. Item # 5 will require formal documented corrective action when determined by the Quality Manager that such documented corrective action is necessary. Notification Required: AML notifies customers in detail in a timely manner when nonconformity is discovered at AML , or in products that may affect product already delivered. The notification on will include concise description of discrepancy, parts and serial numbers affected, lot number, delivered quantity, delivery dates and a statement of corrective action for the noted discrepancy. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: Not applicable. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
TITLE: CONTROL AND CUSTOMER SUSPECT PRODUCT PROCEDURE NUMBER: 8.3 A REV: A DATE: 02-15-2005
NOTIFICATION
OF
PURPOSE: To establish a procedure for the notification to customers when work is suspect of having been calibrated/inspected with a piece of equipment that is out of calibration, within calibration but suspect of producing erroneous data, or of errors in inspection or documentation. SCOPE: This procedure applies to all product calibrated/inspected or tested. DEFINITION: Suspect data is the data produces by equipment that may be out of calibration but that equipment is producing accurate data, data that is produced from a piece of equipment that is within the calibration cycle dates, but in the opinion of management the data should be re-measured for confirmation of accuracy, or any data that in the opinion of management should be reviewed for possible error. RESPONSIBILITY: The President is responsible for the implementation of this procedure. PROCEDURE: Every calibration/inspection job will require a confirmation by the inspector that the equipment being used is within the calibration cycle. When equipment is found to be out of calibration, all jobs that were measured with that equipment will be re-measured (if the parts are still in-house). If the parts have been shipped, a notification letter will be sent to the customer that will identify the suspect part number, the reason for the concern, and for the customer to decide if the suspect parts will be sent back for re-measuring with equipment that is in calibration, or if the parts are to be re-measured at the customers facility using customer or company equipment. If equipment is within calibration, but in the opinion of management the equipment displays performance that may have created inaccurate data, the above noted notification letter will be sent for parts shipped, and parts inhouse will be re-measured. When data is suspect of being incorrect for any reason, the part will be re-measured in-house, or submit to the customer a notification letter as noted above. REMEASUREMENT OF PARTS: The suspect parts will be re-measured to the same criteria as if no initial measurement had been performed, when the parts are in-house. For parts already shipped the customer will decide if the parts are to be returned for complete re-measurement, or if inspection at their facility will be performed. When data is suspect of having inaccuracies, the data will be reviewed for disposition. The disposition may include correction of clerical errors, or re-inspection in part or whole. SUSPECT PART TRACEABILITY: All products are tracked daily for inspection status. All jobs will be reviewed to derive the first completed job that was inspected with the suspect equipment under suspect conditions. All jobs from that point will be considered suspect, and will be re-measured if in-house, or the customer will be notified. CORRECTIVE ACTION: All suspect equipment or data will be reviewed by the President for the application of corrective and preventive action per the Corrective Action Procedure. RECORDS: All records will be maintained in accordance to procedure 4.2.4 Control of Quality Records REFERENCES: None. NATURE OF CHANGES: New.
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 32 of 36
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Approved ______Bipin
Mukherji_____
Date:___2/15/05-
Page 36 of 36