This web page was developed in response to several Vendor Self Audit Questionnaires and updated in January 2011. Many questionnaires are designed for manufacturing subcontractors, microbiological laboratories, or calibration providers may have limited applicability to our analytical testing services. Below are the most frequently asked questions (FAQ) that are appropriate for the services that we provide. Refer to our Quality Manual for more detailed information. Our quality system SOPs may be found under the General SOPs section of this website for more detailed information about our quality systems.

1. Mailing and Physical Address and Phone Numbers:

Exova Inc.

9240 Santa Fe Springs Rd.

Santa Fe Springs, CA 90670

562-948-2225

Fax 562-948-5850

 

2. Key Contacts:

Eric Lindsay, General Manager | 562-948-2225 ext. 300 email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Lorraine Shelton, HSEQ Officer | 562-948-2225 ext. 107 email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Mike Shelton, Technical Director | 562-948-2225 ext. 602 email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

3. Products and services:

We primarily offer analytical chemistry services (chemical testing services) for the pharmaceutical, dietary supplement, medical device, consumer product, and environmental industries and are part of a global group of testing laboratories. Exova global services are provided to the aerospace, oil and gas, retail product, food, and many other industries.

 

4. Date established: 1984. Moved to current location in 2001. Purchased in 2006 by Bodycote. Purchased in 2008 by a private equity firm and rebranded as Exova.

 

5. Number of employees: approximately 55

 

6. Size of facility: 35,000 sq. ft.

 

7. Quality Assurance (QA) and Quality Control (QC):

Our company operates routinely under FDA cGMP as a quality control laboratory. Data is reviewed by a second qualified analyst and, in addition, GMP analyses are reviewed by a QA chemist. Our QA Unit is an independent monitoring function of our operations, reporting directly to the General Manager and Corporate QA. QC activities are performed with each quantitative analysis to monitor the precision, accuracy, and other applicable parameters of the method. Reports include QC data, including demonstration of precision and accuracy.

We have a QA Manual and a formal QA Program certified as compliant with the California Environmental Laboratory Accreditation Program (NELAP recognized) and inspected for compliance with FDA cGMP regulations. We are also capable of FDA and EPA GLP compliance with pre-approval of the study protocol. This includes QA witnessing of critical control points. Our QA Manual and the appropriateness / effectiveness of our quality systems are reviewed annually in a formal Annual Management Review which includes corporate management. QA performs internal audits according to SOP 250.

8. ISO Certification:

We are not currently ISO certified, but our quality systems are compliant with ISO 9001 and 17025.

9. FDA Registration:

Facility Establishment Identifier/Data Universal Numbering System Number: 3000203007/126601801

 

10. CA ELAP Certificate:

Certificate #2652, accredited since the beginning of the ELAP program in the mid 1980’s.

11. Regulatory Inspections and Client Audits:

 

The FDA has audited our lab at a minimum of every two years since 1996. We have had no FDA Form 483 issued in our past two inspections.

CA ELAP last inspected our laboratory in 2006. EPA has audited our lab once in response to a pesticide application in which data from a GLP project was submitted in support of the application.

Clients routinely visit our labs for audits. We average about 25-30 client audits per year. Contact the HSEQ Officer to schedule an audit of our laboratory.

12. QA Policies

A) Raw Materials Control, Supplier Qualification.

While we do not test incoming raw materials against their specifications, certificates of analysis are reviewed by QA as part of our incoming materials system, which includes expiration dating (SOP 2280 ). We maintain an approved supplier list, managed by our corporate entity. We also qualify working standards against a second source or reference standard (SOP 2100 ). For example, if a copper standard is used, the test will include a comparison to a reference sample, an NIST (or other primary standard) traceable Certified Reference Material (CRM). In the case of reagents used in titrations, these are standardized against standards traceable to a primary standard. General reagents, which may affect analyte recovery or blank contamination, are monitored with every batch of test samples.

We do not subcontract analytical work. However, upon request, we can subsample and forward aliquots to other laboratories pre-approved by the client. Their Certificate of Analysis will be forwarded to the client as received by our lab. It is the client's responsibility to qualify such laboratories. We use ISO 17025 certified calibration service providers.

B) Analytical Instrument Qualification.

Each instrument has a use and preventative maintenance log. Analytical instrumentation is Operationally Qualified at least once per year. Instrumentation is qualified before use and following major repairs (Installation Qualification and Operational Qualification) per SOP 2250. Complex analytical instrumentation is qualified holistically and/or calibrated at the time of use for particular tests according to system suitability criteria published in standard methods or SOPs (Performance Qualification). There are three categories of laboratory equipment that fall under the responsibility of in-house metrology: thermometers, mechanical pipettes, and balances. Calibration is verified periodically with weights and measures traceable to NIST, as formalized in our SOPs.

C) Training.

Training records are kept according to GMP regulations. Training is usually conducted "on-the-job", teaming a qualified analyst with one in training. Training is also conducted in QA Meetings every other month, at which time regulations, new or updated SOPs, and other QA issues are covered. Training is also conducted on specific instrument or analytical specialties during both in-house and external seminars. Efficacy of Training is established on an annual basis for elements of an analyst's curriculum, based on a review of the analyst's data, including performance during third-party proficiency testing. Training documentation is explained in SOP 140.

D) Document Control.

The manner in which controlled documents, including test methods, are reviewed, revised, distributed, and tracked is explained in SOP 101. Laboratory data is recorded on controlled worksheets or bound laboratory notebooks, issued by QA.

E) Customer Complaints.

See SOP 190. Any complaint which expresses serious concern over the quality of our data, or significantly questions a result is logged into a complaint database and an investigation conducted. We attempt to resolve the conflict with the client. Complaints are trended by QA and reported to management.

F) OOS and Laboratory Investigation Policy.

See SOP 2230. An OOS investigation is conducted if the client has supplied a material specification with the analytical request or indicates that a sample result is out-of-trend or aberrant.

Out of control QC or system suitability parameters do not require an OOS investigation. These are handled separately through data review procedures and corrective action forms, per SOP 2160.

G) Traceability.

Test measurements are traceable to primary standards through the use of NIST traceable weights and measures, traceable secondary standards, and the use of primary standards from NIST, USP, USEPA, USGS, etc..

H) Non-Conformances (Deviations) and Corrective/Preventative Actions (CAPA)

Non-conformances (deviations) from methods or SOPs are documented in the raw data package and identified in the report, including an impact assessment or justification. Planned deviations require client pre-approval. Unplanned deviations most commonly result from use of test methods that have not been validated in the client's particular sample matrix, resulting in unexpected interferences. Laboratory errors are documented, corrective and preventative actions identified, and a root cause analysis performed per SOP 270 . CAPAs are tracked to completion and trend analyses are performed by QA. Management is updated regularly on evolving trends and timeliness of NCR/CAPA closure.

I) Record retention.

Raw data is stored for seven (7) years. We realize that this is not sufficient for many of our clients, however it would be difficult to track the data retention requirements for every product, industry, and client. Therefore we recommend that clients order a GMP data package in order to archive the raw data associated with testing themselves. This data package includes copies of all hard copy raw data, complete explanations of sample preparation and analysis, and documents the independent QA audit of the raw data. Complete raw data packages are provided at an additional cost.

J) Method Validation.

Not all methods and SOPs have been validated in each potential matrix. Methods from compendial sources such as USP, ACS, and EPA may not require full validation. Instead they generally require demonstration of system suitability or another form of initial demonstration of performance (method qualification). Methods which are developed by our laboratory or a client may be validated on the client's product or material in accordance with USP and ICH 2Q (R1) or qualified per USP upon request. See SOP 2220 for minimum validation requirements. FDA requires non-compendial methods for in scope GMP work to be validated or transferred for each matrix. Contact us for a price quote and for assistance in developing a protocol.

K) Sample receipt, storage, and disposal.

Upon sample receipt, the Analytical Request Form or Chain of Custody is reviewed, samples are uniquely identified, and samples are then stored according to label requirements or EPA protocols per SOP 1500. If any discrepancies are noted in the condition of the sample, its container, or with the request for analysis, the client is contacted immediately. Samples are stored separately from standards and reference materials. Refrigerators, freezers, and room temperature storage areas used for GMP materials have been mapped and are continually monitored with calibrated thermometers, per SOP 1510. Samples are kept in storage for 30 days after the report is mailed. The report will include a post card for the client to return with sample disposal or return instructions.

L) Contamination Controls.

SOP 240 describes our procedures in detail for housekeeping, security, and pest control. We also have formal programs in place for glassware cleaning (SOP 2800 and SOP 7820).

M) Change Control.

SOP 220 describes our procedures in detail for change control. Impact assessments are performed by QA and notification of clients is performed when appropriate. Specific SOP or standard method versions may be requested by our clients on the Analytical Request Form accompanying samples; client notification will occur if the requested version is not our current version. Validated, client/matrix specific test methods require client notification before implementation of changes.

N) Data Integrity and Part 11 Compliance.

Analytical instrument computer systems have been validated to ensure compliance with data integrity expectations of the FDA and requirements of 21CFR Part 11 per SOP 2250 .