ISO 9001:2000 +AS9100 Audit Checklist

JPL MRO Pre-bid Mission Assurance Audit Checklist (rev 6-7-01)ISO

Para.Contractq.ATTRIBUTEMETHOD OF VERIFICATIONSupplier DocumentResults

REMARKS

ISO

Para.Contract

Req.ATTRIBUTEMETHOD OF VERIFICATIONSupplier DocumentResults

REMARKS

NASAs

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

Process Audit Checklist, Rev. ASupplier 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

2.1Certification requirements for Clean Rooms

2.1 Contamination Control Laboratory personnel shall perform Laminar Flow Clean Room, Clean Bench and Controlled Environment Certification for the JPL community per the ISO/DIS 14644-2: 1998 (E) Standard (available through http://standards.nasa.gov/).

Verify that certification requirements have been performed per ISO/DIS 14644-2:1998 Standard.

2.1.1

The Contamination Control Services Laboratory shall maintain the certification, High Efficiency Particulate Air Filter (HEPA)/Ultra Low Penetration Air Filter (ULPA), and pre-filter replacement status for all of these sites in order to comply with the documentation requirements of ISO. Request to see the filter replacement log or database and verifty the status on frequency replacement of filters.

2.2

The Classification of the Clean Areas shall be documented per the ISO 14644-1 standard (available through http://standards.nasa.gov/).Ensure that the log or database identifies the classification of the Clean Areas.

2.3The ISO 14644-1 tests shall include but are not limited to airborne particulate counting and sizing, air velocity testing, and differential pressure testing. Select random samples and verify that tests are performed per ISO standard above.

2.5

The Controlled Environment areas (> class 100,000) shall require only particulate testing unless otherwise requested by the customer.Verify records that particulate testing has been performed on Clean Rooms Class 100,000 or greater.

3.0REQUIRED TESTING

3.1Contamination Control personnel shall measure the square footage of each Clean Room or Controlled Environment to establish the number of samples to be taken in the area.Verify testing records show evidence that the square footage has been measured and recorded.

3.2The Contamination Control personnel shall take the proper number of samples at each location as defined by the ISO 14644-1 Annex B Section B.4.1.1 using a (DPC) Calibrated particle counter (Calibrated within 180 days designated to count the required particle sizes for the area which will determine the classification of the clean area.

Select a ramdom sample of test results and verify that the appropriate number of samples were taken per the ISO standard.

3.3Contamination Control personnel shall perform a velocity test in the clean area.Ensure that the velocity test was performed.

3.4The number of tests performed shall be based on the square footage of the area.Verify that the number of tests coincide with square footage of the area.

3.5Testing information shall be recorded on the certification data or memo to the customer.Review the certification document and verify that testing information is included.

3.6Contamination Control personnel shall determine if the flow is adequate for the specified area and make recommendations to the customer in writing where the flow is deemed to be low or out of specification.

Seek evidence that recommendations have been made in writing by reviewing test records.

3.7Differential pressure readings shall be performed in all clean areas to determine the existence of positive pressure.

Ensure that differential pressure test was performed and the resulting data was provided to the cusotmer.

3.10The Contamination Control personnel shall perform a visual cleanliness survey of the Clean Area to be tested under the ISO standard.

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.Ensure that a visual for cleanliness has been performed per specification and recorded and filed.

3.11The Contamination Control Laboratory shall perform Low-Volatile Residue sampling by providing a clean sample plate (for airborne collection) or (wipe samples) for product testing if required by the customer.

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.

When required by the customer, ensure that the Low-Volatile Residue sampling has been performed.

4.0 GARMENT REQUIREMENTS

4.1 Minimum Garment Requirements for Clean Rooms, Controlled Environments and Work Stations.

Table 1 (below) shall be used as the minimum requirements for clean rooms, controlled environments, and workstations (as specified in ASTM E2352-04, available through http://standards.nasa.gov/)

Review the specification and verify that the requirements listed in Table 1 have been met as a minimum.

5.0 OUTSIDE CONTRACTOR CLEAN ROOM CERTIFICATIONS AND REQUIREMENTS

5.1

Contractors who perform work on JPL clean rooms shall comply with all the applicable requirements set forth in the ISO 14644-1 and ISO/DIS 14644-2: 1998 (E) controlling documents.

Refer to ISO documents referenced and ensure requirements have been complied with.

5.3The contractor shall supply to the JPL Contamination Control Laboratory a documentation package that certifies the work complies with all the ISO standard requirements, and specifies the type of work performed, and any optional tests performed.

Ensure that the contractor satisfies this requirement and verify that it is per ISO.

5.4

The contractor shall build the new Clean Room facility in accordance to the ISO 14644 documents and supply the JPL Contamination Control Laboratory documentation which shall include all tests in accordance with that document, and sizes, part number of manufacturer number, and 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.

Review the documents supplied to the JPL Contamination Control Laboratory documentation and verify that requirements in ISO have been met.

6.0HEPA/ULPA AND RELATED FILTER REPLACEMENTS

6.1

HEPA filters that are over the manufacuturers recommended life expectancy of 5 years shall be tested for large particulate by deploying witness plates in the clean room area to determine if the HEPA filter is degrading.

Note:

The HEPA/ULPA filters have a life expectancy of 3-5 years in accordance with the manufacturers recommendations. Typically the filters at JPL require replancement in 6-7 years. There are some filters that have been purchased by JPL that hve a life expectancy of 10 years, warranted by the manufacturer, at additional costs.

Under such condition, verify that filter degradation has been tested and recorded.

6.2The Contamination Control personnel shall determine by the tests performed in the certification process when the filter require replacement based on the airflow or the differential pressure drop of the filter.

Ensure that Contamination Control certification includes tests performed to determine when filter replacement is required.

6.4All HEPA filters older than 7 years old shall be replaced.

Notes:

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.

Review filter log/records and verify that these fitlers have been replaced at the 7th year of use or before.

7.0CERTIFICATION CLASS LEVELS

7.1The Clean Room, Controlled Environment or Clean Bench shall have a designated class level number N which corresponds to the ISO 14644-1 Table 2 cleanliness classes.

Verify that the designated area is marked with the class number.

7.7Re-certification tests shall be performed on the clean rooms at specific intervals to demonstrate compliance with ISO 14644-1 according to the classification of the installation.

Select a sample of records and verify that re-certification tests were performed at specific intervals.

8.0CERTIFICATION LABEL

8.2This label shall identify the location, (NASA I.D. # on clean benches or clean tents) Classification, Date of Certification, the next Certification date and other tests performed.

Ensure that the label identifying the location has all the proper information.

10.0RECORD KEEPING

10.2The certification or non-compliance tests data shall be entered into the computer database.

Note:

The data shall include the certification classification or non-compliance data of the clean room, clean bench or controlled environment, the date of the test, re-certification date, the standard to which the test was performed, the location and identification code or NASA property number.

Request to see the database information and verify it.

10.4An Inter-Office Memo shall be initiated with the classification, differential pressure and velocity data, customers name, charge number, location of the work performed and the calibration date of the particle counter.

Request a copy of the memo and verify all the pertinent information has been included.

11.0REPORTING TO THE CUSTOMER

11.1

The Contamination Control Laboratory shall provide the customer with all the data related to the customers clean room, controlled environment or clean bench for compliance with the ISO standards in a memo form.

Ensure that the customer has been informed of clean room compliance to ISO.

RESULTS CODES;M = MAJOR NONCONFORMANCEC = COMMENDATION

N = MINOR NONCONFORMANCES = VERIFIED SATISFACTORY

O = OBSERVATIONN/A = NOT AUDITED