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An Independently Prepared Second Source Lot Reference Material – Where Did This Come From and What Does It Really Mean?
Oral Presentation
Prepared by J. Konschnik1, J. Fisher2, R. Vitale3, L. Dupes4, J. Parr5, R. Knake6, C. Gunning7
1 - RESTEK Corporation, 110 Benner Circle, Bellefonte, PA, 18623
2 - RESTEK Corporation, 110 Benner Circle, Bellefonte, PA, 18623
3 - Environmental Standards, Inc., 1140 Valley Forge Rd., Valley Forge, PA, 19482
4 - Environmental Standards, Inc., 1140 Valley Forge Rd., Valley Forge, PA, 19482
5 - Catalyst Information Resources, 210 S. Lamar St., Weatherford, TX, 76086
6 - A2LA, 5301 Buckeystown Pike, Suite 350, Frederick, MD, 21701
7 - A2LA, 5301 Buckeystown Pike, Suite 350, Frederick, MD, 21701
Contact Information: joe.konschnik@restek.com; 302-838-5796
ABSTRACT
For years environmental laboratories throughout the US have been required to verify the calibration standards they use for their instrument initial calibration using an independently prepared second source lot reference standard. The description of this second source lot is contained in various national and state-published standards and quality assurance program manuals. Laboratories are audited for compliance to such written standards; however there is ambiguity in terms of what a “second source lot” means. The definition of second source is typically determined by the auditors representing accrediting bodies, state regulatory agencies, or federal program quality assurance manuals. Since the interpretation is left to the auditing professional based on the information available and to a large extent, their own professional opinion, the definition may vary from one auditor to another, or among different programs for the same laboratory. This creates confusion for the laboratory and complicates the quality assurance procedures they must follow in order to remain compliant with multiple program requirements.
This presentation will provide an overview of the origin of the second source requirement and examine the published statements describing it. Viewpoints of the auditors, accrediting bodies, laboratories and reference standard manufacturers will be included with the intent to raise awareness of the ambiguity of current definitions and proposed universal definitions of what a “true independent second source lot” reference standard represents. Also presented is an actual case study where a reference standard manufacturer either procured, or attempted to procure independently manufactured raw material sources for organic compounds used in the manufacture of Certified Reference Materials. Their findings will be shared with regard to the impacts on the quality and cost of their reference standards manufacturing processes, and the products themselves.
Oral Presentation
Prepared by J. Konschnik1, J. Fisher2, R. Vitale3, L. Dupes4, J. Parr5, R. Knake6, C. Gunning7
1 - RESTEK Corporation, 110 Benner Circle, Bellefonte, PA, 18623
2 - RESTEK Corporation, 110 Benner Circle, Bellefonte, PA, 18623
3 - Environmental Standards, Inc., 1140 Valley Forge Rd., Valley Forge, PA, 19482
4 - Environmental Standards, Inc., 1140 Valley Forge Rd., Valley Forge, PA, 19482
5 - Catalyst Information Resources, 210 S. Lamar St., Weatherford, TX, 76086
6 - A2LA, 5301 Buckeystown Pike, Suite 350, Frederick, MD, 21701
7 - A2LA, 5301 Buckeystown Pike, Suite 350, Frederick, MD, 21701
Contact Information: joe.konschnik@restek.com; 302-838-5796
ABSTRACT
For years environmental laboratories throughout the US have been required to verify the calibration standards they use for their instrument initial calibration using an independently prepared second source lot reference standard. The description of this second source lot is contained in various national and state-published standards and quality assurance program manuals. Laboratories are audited for compliance to such written standards; however there is ambiguity in terms of what a “second source lot” means. The definition of second source is typically determined by the auditors representing accrediting bodies, state regulatory agencies, or federal program quality assurance manuals. Since the interpretation is left to the auditing professional based on the information available and to a large extent, their own professional opinion, the definition may vary from one auditor to another, or among different programs for the same laboratory. This creates confusion for the laboratory and complicates the quality assurance procedures they must follow in order to remain compliant with multiple program requirements.
This presentation will provide an overview of the origin of the second source requirement and examine the published statements describing it. Viewpoints of the auditors, accrediting bodies, laboratories and reference standard manufacturers will be included with the intent to raise awareness of the ambiguity of current definitions and proposed universal definitions of what a “true independent second source lot” reference standard represents. Also presented is an actual case study where a reference standard manufacturer either procured, or attempted to procure independently manufactured raw material sources for organic compounds used in the manufacture of Certified Reference Materials. Their findings will be shared with regard to the impacts on the quality and cost of their reference standards manufacturing processes, and the products themselves.