QAQC Example
The responsibility of Quality Assurance lies with the owner(s). The Quality Assurance Director is responsible for overseeing the total Quality Control function. The Quality Assurance Director has the authority to stop work that is found to be nonconforming, or out of the scope of contract documents. The Quality Assurance Director has the responsibility to find a solution to the problem and inform management for implementation. The Quality Assurance Director will report periodically on the effectiveness of the inspection system plan to management. Additional Quality Assurance criteria furnished by the Customer shall be filed by Customer name and will automatically become part of this plan, and shall be binding to sub-tier vendors as applicable.
MATERIAL & FABRICATION FLOW CHART
Contract Received
Quality Data Package Initiated
Contract and Flow Tag Review
Purchase Orders for Items and Materials Reviewed
Purchase Orders for Outside Services Reviewed
Drawings Reviewed
RECIEVING INSPECTION
FABRICATION
QUALITY CONTROL RECORDS
Records contained in the Quality Data Package are the principal form of objective evidence of Quality. They shall be maintained in a manner to provide data required for conducting business with the Customer. The records will reflect the nature and number of observations together with the number and types of deficiencies found. They must also indicate the acceptability of the product and actions taken in connection with deficiencies.
A Quality Data Package will be assembled for each project. The Quality Assurance Manager, or their designated representative, is responsible for compiling all required documentation and supporting paperwork required for Customer verification and acceptance of the Quality Data Package.
Upon completion of project, the Quality Data Package shall be reviewed by the Quality Assurance Manager for completeness and accuracy of documents and retained for a period of seven (7) years, and a copy given to the Customer, if specified by contract documents. The records shall be maintained by the Quality Assurance Engineer for retrieval during this period of time.
RECORDS TO BE MAINTAINED
Records to be maintained in the Quality Data Package include, but are not limited to:
Purchase Orders
Inspection Reports
NDT Records
ECO Records
All NCR occurrences
Calibration Reports
Mill Reports And Certifications
Process And Metallurgical Reports
Red-Lined Drawings
Vendor History File
DESIGN CONTROL
At the beginning of the design process, applicable design inputs (i.e., design bases, performance requirements, Customer contract requirements, regulatory requirements, codes, and standards) shall be identified and documented. Design criteria for fit, form, function, manufacturing, processing, testing, inspection and safety shall be defined, when applicable.
All engineering calculations and analysis shall be done in accordance with industrial mechanical codes and the requirements of the Customer. The work shall be directed and approved by an engineer familiar with the type of analysis to be performed.
All designs, including drawings, will undergo a design review by knowledgeable personnel other than those who originated the drawings (i.e., QA, Production, and Purchasing). The intent of the design review shall be to verify conformance to design criteria, producibility, inspectability and adequacy to project specifications. The final responsibility of design adequacy lies with the SDS.
DRAFTING CONTROLS
Product design and technical review is the responsibility of the "Engineering Group". The "Engineering Group" is responsible to generate the working drawings and other documents necessary to manufacture products or tooling.
Prior to release for production, all drawings required for product manufacture will be drafted, checked and approved by all applicable personnel.
All drawings will be per ANSI Y14.5 (latest revision).
Drawings will be numbered using a project based drawing number system. All drawing changes and revisions will be approved and issued per the SDS Engineering Drawing Standards, or Customer contractual requirements.
QA REVIEW
All initial drawings, changes and/or revisions will be initiated with a Signature Block for Quality Assurance review and approval. The Quality Assurance Signature Block must be signed prior to release of the drawing(s) for production purposes, or submitted to Customer for approval in accordance with contractual specifications. The review shall include, but not be limited to:
Appropriate materials called out
All special processing specifications are properly reflected and current.
All drawings comply with ANSI Y14.5 (latest revision).
Capability for adequate inspections are available and cost effective.
Meets all Customer contractual requirements.
If the drawings, changes, or revisions are acceptable, the Quality Assurance Manager performing the review will sign in the appropriate space and return the documents to the Engineering department. If the Quality Assurance Manager has questions or discovers discrepancies in the documents, they shall coordinate with Engineering to resolve the discrepancies.
DRAWING RELEASE
Upon acceptance of a drawing from the Engineering department, or upon receipt of Customer furnished drawings, a Drawing Control Form will be generated which shall indicate the drawing number, current revision and any applicable engineering change notices.
Upon receipt of the drawings, the Engineering Department Manager will stamp and distribute the drawings to the required departments. Each stamp will indicate the department to which the drawing is being issued and other required information; (i.e., “For Information Only”, “Uncontrolled Drawing”, “Reference Only”, etc.). Under no circumstances will a drawing be issued without an appropriate stamp.
All Customer furnished drawings will be filed in the Customer Control Drawing File.
Prior to release of the revised drawing, Drawing Control personnel will obtain the obsolete drawing from each department.
INSPECTION AND TEST RECORDS
Inspections shall be recorded on Form # ______________
All records of inspection, tests, documentation of conformance, procurement, non- conformance and corrective action shall be inserted in the Quality Data Package
NONCONFORMING ITEMS OR MATERIALS
Minor discrepancies may be corrected at the time of discovery with concurrence of the Quality Assurance Controller. All other discrepancies will be recorded on a Nonconformance Report (NCR) when an item(s) or material(s) are found not conforming to drawings, specifications or other requirements. All applicable information will be filled out by a Quality Assurance representative. The NCR Form shall include the following information:
A unique document number that is identifiable to the work order.
The nomenclature and identification of the nonconforming item(s) or material(s).
A description of the nonconformance and its required drawing and/or specification characteristic or design criteria.
Cause or reason for the nonconformance.
Corrective action taken or recommended.
Disposition of the nonconforming item or material.
Initiator of the document.
Signatures of authorized personnel.
NCR DISPOSITION
Company policy dictates that a Nonconformance Report requires disposition. Report to include -the outcome of the nonconformance handling process, which includes the immediate action taken, the corrective actions, and the preventive actions
Upon completion of the a NCR, the discrepant item(s) or material(s) shall be tagged with a Rejection Tag and be segregated from production operations until final Material Review Board (MRB) disposition if applicable.
CORRECTIVE ACTION
The Quality Assurance Controller shall document corrective and preventive action on each nonconformance, including:
A conducting analyses and examinations of nonconforming items, materials, or conditions, to the extent necessary to isolate and determine the cause(s) or reason(s) for the nonconformance.
Conduct timely and effective corrective action to ensure the correction of the nonconforming items, materials, or conditions.
Conduct timely and effective preventive action to prevent recurrence of the nonconformance. This includes correction of related drawings, specifications, or procedures; correction of other identical items or materials at all locations.
Assign responsibility for follow-up of corrective and preventive actions to ensure satisfactory accomplishment.
Notify responsible organizational elements of nonconformances and the need for corrective and preventive actions.
Document analyses and corrective and preventive actions.
Close out nonconformance documentation after verifying that effective corrective and preventive actions have been taken.
Notify the Customer of nonconformances and their related corrective and preventive actions, as required by contract.
CALIBRATION
All procedures used in calibration of all equipment shall be in accordance with the tool manufacturer’s recommended procedures, and shall comply with MIL-STD- 45662A.
Scheduled calibration intervals are six months to one year. When calibrated at the time of usage, the scheduled calibration date shall not change. Intervals may be less than six months and one year depending on the use, accuracy and other conditions affecting quality.
In-House and Vendor Calibration
Precision tool calibration performed shall be accomplished by or under the supervision of the Quality Assurance Shop Manager.
Storage and calibration shall be conducted in a temperature and humidity controlled environment.
Standards and gage blocks used for calibration shall be calibrated by (calibration company name). All standards shall be traceable to the National Institute of Science and Technology (NIST).
All measurement standards and equipment shall be handled, stored and transported in a manner which shall not adversely affect quality nor result in damage.
Measurement standards and equipment shall have labels that indicate tool number, due date of next calibration, and identification of personnel or facility performing the calibration. In the event of limited calibration, the limits for accuracy and range shall be indicated.
All standards and equipment used in the measurement process shall be recalled and recalibrated at established intervals. Standards and equipment not recalibrated before the recall due date shall be removed from service or otherwise restricted from use.
CALIBRATION RECORDS
The Quality Assurance Shop Manager shall maintain individual file card records on measurement standards and equipment. A permanent record on each standard or tool shall indicate the calibration history. These records shall include, but not be limited to the following:
Serial number, description and manufacturer of the standard or equipment to be calibrated.
Identification of standard, equipment, and calibration procedure utilized in the calibration process.
Scheduled calibration intervals.
Dates and results of each calibration.
Scheduled date of next calibration.
Personnel performing calibration.
Calibration facility.
Degree of nonconformity to standards or equipment. This will indicate when replacement is necessary.
Subcontractor Calibration
In instances where a subcontractor will ship directly to the Customer, or where a subassembly will be received from subcontractor in such a state of assembly that detailed inspection at SDS would be impossible or impracticable, the subcontractor will have in effect a calibration program which meets or exceeds the requirements of this program. This requirement will be noted on Purchase Orders to the subcontractors. Compliance will be assured by SDS audit at unscheduled intervals. Audit results will be recorded on the Subcontractor Inspection Report.
PACKAGING AND SHIPPING CONTROLS
PACKAGING
Preservation methods and packaging designs shall be consistent with desired performance. The preservation methods and packaging methods selected shall ensure adequate protection.
FINAL REVIEW
Before any items are shipped, the Customer is to be contacted to verify that no change orders are pending.
SHIPPING
All completed product will be processed by the Shipping Department for shipment after final testing and Quality Control acceptance.
Items will be shipped in accordance with accepted industry standards or contract documents. All required documentation (i.e., shipping ticket, packing slip, bill of lading, Customer requirements, etc.) will accompany the product to the consignee.