ISO 9001:2000 +AS9100 Audit Checklist



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NASA’s

Test and Certification for Clean Rooms, Benches, and Controlled Environments, Rev. 1, Ref. JPL DocID 42636

Process Audit Checklist, Rev. A

Supplier Audited:________________________________________________________________

Audit Date:___________________________________________________________________

Auditor(s):__________________________________________________________________

Reviewed by: Approved by:

_______________________________ _______________________________

SME Olga Ceritelli

Title Procurement Quality Assurance Lead

July, 2005 July, 2005

Prepared by:

_____________________________ _____________________________

Tony Gutierrez Harrel B. Crenshaw

Procurement Quality Assurance - QE Group Supervisor, Procurement Quality Assurance

July, 2005 July, 2005

|2.0 | | REQUIREMENTS | | | | |

|2.1 | |Certification requirements for Clean Rooms | | | | |

|2.1.1 | | | | | | |

| | |The Contamination Control Services Laboratory shall maintain the |Request to see the filter replacement log or | | | |

| | |certification, High Efficiency Particulate Air Filter (HEPA)/Ultra Low |database and verifty the status on frequency | | | |

| | |Penetration Air Filter (ULPA), and pre-filter replacement status for all |replacement of filters. | | | |

| | |of these sites in order to comply with the documentation requirements of | | | | |

| | |ISO. | | | | |

| | | | | | | |

| | | | | | | |

|2.2 | | | | | | |

| | |The Classification of the Clean Areas shall be documented per the ISO |Ensure that the log or database identifies the | | | |

| | |14644-1 standard (available through ). |classification of the Clean Areas. | | | |

| | | | | | | |

|2.3 | | | | | | |

| | |The ISO 14644-1 tests shall include but are not limited to airborne |Select random samples and verify that tests are| | | |

| | |particulate counting and sizing, air velocity testing, and differential |performed per ISO standard above. | | | |

| | |pressure testing. | | | | |

|2.5 | | | | | | |

| | |The Controlled Environment areas (> class 100,000) shall require only |Verify records that particulate testing has | | | |

| | |particulate testing unless otherwise requested by the customer. |been performed on Clean Rooms Class 100,000 or | | | |

| | | |greater. | | | |

| | | | | | | |

|3.0 | |REQUIRED TESTING  | | | | |

|3.2 | | | | | | |

| | |The Contamination Control personnel shall take the proper number of |Select a ramdom sample of test results and | | | |

| | |samples at each location as defined by the ISO 14644-1 Annex B Section |verify that the appropriate number of samples | | | |

| | |B.4.1.1 using a (DPC) Calibrated particle counter (Calibrated within 180 |were taken per the ISO standard. | | | |

| | |days designated to count the required particle sizes for the area which | | | | |

| | |will determine the classification of the clean area. | | | | |

|3.3 | | | | | | |

| | |Contamination Control personnel shall perform a velocity test in the |Ensure that the velocity test was performed. | | | |

| | |clean area. | | | | |

|3.4 | | | | | | |

| | |The number of tests performed shall be based on the square footage of the|Verify that the number of tests coincide with | | | |

| | |area. |square footage of the area. | | | |

|3.5 | | | | | | |

| | |Testing information shall be recorded on the certification data or memo |Review the certification document and verify | | | |

| | |to the customer. |that testing information is included. | | | |

|3.6 | | | | | | |

| | |Contamination Control personnel shall determine if the flow is adequate |Seek evidence that recommendations have been | | | |

| | |for the specified area and make recommendations to the customer in |made in writing by reviewing test records. | | | |

| | |writing where the flow is deemed to be low or out of specification. | | | | |

|3.7 | | | | | | |

| | |Differential pressure readings shall be performed in all clean areas to |Ensure that differential pressure test was | | | |

| | |determine the existence of positive pressure. |performed and the resulting data was provided | | | |

| | | |to the cusotmer. | | | |

|3.10 | | | | | | |

| | |The Contamination Control personnel shall perform a visual cleanliness |Ensure that a visual for cleanliness has been | | | |

| | |survey of the Clean Area to be tested under the ISO standard. |performed per specification and recorded and | | | |

| | | |filed. | | | |

| | |Note : | | | | |

| | |This visual cleanliness survey shall be conducted per the SN-C-0005 | | | | |

| | |Contamination Control Requirements for the Space Shuttle (Section 1.4) | | | | |

| | |for visual cleanliness. | | | | |

|3.11 | | | | | | |

| | |The Contamination Control Laboratory shall perform Low-Volatile Residue |When required by the customer, ensure that the | | | |

| | |sampling by providing a clean sample plate (for airborne collection) or |Low-Volatile Residue sampling has been | | | |

| | |(wipe samples) for product testing if required by the customer. |performed. | | | |

| | | | | | | |

| | |Note : | | | | |

| | |The following testing shall be optional. | | | | |

| | | | | | | |

| | |The Contamination Control Lab can provide particulate fallout plates to | | | | |

| | |determine the larger size particulates that may be entering the clean | | | | |

| | |area. | | | | |

| | |Tapelift samples can be provided for testing hardware cleanliness, | | | | |

| | |cleanliness of the walls , floors or any equipment in the clean area. | | | | |

|4.0 | | GARMENT REQUIREMENTS | | | | |

|5.0 | | OUTSIDE CONTRACTOR CLEAN ROOM CERTIFICATIONS AND REQUIREMENTS | | | | |

|5.3 | | | | | | |

| | |The contractor shall supply to the JPL Contamination Control Laboratory a|Ensure that the contractor satisfies this | | | |

| | |documentation package that certifies the work complies with all the ISO |requirement and verify that it is per ISO. | | | |

| | |standard requirements, and specifies the type of work performed, and any | | | | |

| | |optional tests performed. | | | | |

|5.4 | | | | | | |

| | |The contractor shall build the new Clean Room facility in accordance to |Review the documents supplied to the JPL | | | |

| | |the ISO 14644 documents and supply the JPL Contamination Control |Contamination Control Laboratory documentation | | | |

| | |Laboratory documentation which shall include all tests in accordance with|and verify that requirements in ISO have been | | | |

| | |that document, and sizes, part number of manufacturer number, and |met. | | | |

| | |statement that the filters were not tested with Dioctylphthalate (DOP), | | | | |

| | |plasticizer test materials or other non-approved JPL test methods with a | | | | |

| | |CNC for the HEPA or ULPA filter installation. | | | | |

| | | | | | | |

| | | | | | | |

|6.0 | |HEPA/ULPA AND RELATED FILTER REPLACEMENTS  | | | | |

|6.2 | | | | | | |

| | |The Contamination Control personnel shall determine by the tests |Ensure that Contamination Control certification| | | |

| | |performed in the certification process when the filter require |includes tests performed to determine when | | | |

| | |replacement based on the airflow or the differential pressure drop of the|filter replacement is required. | | | |

| | |filter. | | | | |

|6.4 | | | | | | |

| | |All HEPA filters older than 7 years old shall be replaced. |Review filter log/records and verify that these| | | |

| | | |fitlers have been replaced at the 7th year of | | | |

| | |Notes: |use or before. | | | |

| | |Waivers for filters older than 7 years shall be reviewed on an individual| | | | |

| | |basis. | | | | |

| | | | | | | |

| | |Clean rooms that have fitlers older than 7 years shall be put in | | | | |

| | |non-compliance. | | | | |

|7.0 | |CERTIFICATION CLASS LEVELS   | | | | |

|7.7 | | | | | | |

| | |Re-certification tests shall be performed on the clean rooms at specific |Select a sample of records and verify that | | | |

| | |intervals to demonstrate compliance with ISO 14644-1 according to the |re-certification tests were performed at | | | |

| | |classification of the installation. |specific intervals. | | | |

|8.0 | |CERTIFICATION LABEL  | | | | |

|10.0 | |RECORD KEEPING  | | | | |

|10.4 | | | | | | |

| | |An Inter-Office Memo shall be initiated with the classification, |Request a copy of the memo and verify all the | | | |

| | |differential pressure and velocity data, customer’s name, charge number, |pertinent information has been included. | | | |

| | |location of the work performed and the calibration date of the particle | | | | |

| | |counter. | | | | |

|11.0 | |REPORTING TO THE CUSTOMER  | | | | |

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