AOAC Food Program Guideline Changes 2018 · 2019. 4. 16. · (AOAC 7.7.2)Pre-Accreditation: The laboratory shall have successful proficiency testing or interlaboratory comparison

AOAC Food Program Guideline Changes 2018

Roger BrauningerA2LA Program Manager

April 11, 2019

A Better World Through Accreditation 2019 by A2LA

Summary of Changes

History/philosophy of revisionWhat was taken outWhat was addedWhat was moved around Notes


History/Philosophy of Revision Strawman group formed in spring 2017 A2LA had some staff members/ assessors who were part of the CASCO

working group. May 2017 CASCO released DIS 17025, May 2017 Strawman group started working on identifying necessary

changes to ALACC Decided to focus on making changes complementing the risk-opportunity

approach of 17025:2017 Opportunity to incorporate previous FAQs


What Was Taken Out

No requirements were removed unless 17025:2017 addressed them Examples: 6.2: Ensuring competency of analysts and ongoing evaluation of

analyst competency 6.6: Ongoing vendor evaluation

Exception: some record-keeping requirements in section 6.3


What Was Taken Out

Appendix A: Ongoing uniformity and stability of temperature controlled chambers

for storage (refrigerators, freezers), temperature controlled chambers for testing (ovens, furnaces, incubators, water baths, autoclaves)

Appendix B: Records for autoclave runs which do not contain media or reagents

(ex. decontamination runs)


What Was Added

4.1.2: Schedule for refresher training on impartiality/conflict of interest 6.2.3: For DS and Pharma, qualified person must

review/investigate complaints, define qualifications needed 6.4.4: CRMs and Media cannot be used past expiry VRB, VRBG, BS


What Was Added

7.2.1.5: Required performance Matrix applicability, LOD, precision

7.3.1: When not responsible for initial sampling, state in report that samples analyzed as received 7.4.1: Procedures for compositing 7.5.1: Clarification of records required


What Was Added

7.7.1: For enumeration assays, a quantified control material shall be used Method precision by evaluating QC material over time

Duplicate CRM/RM, positive samples, matrix spikes, LCSs can be used

7.7.2: Ongoing PT Chemical Scope


What Was Added

7.11.2: Only DS and Pharma electronic records and signatures must meet requirements of 21CFR part 11

8.4.2: Method validation and verification records shall be retained for at

least as long as the method is in use Procedure to periodically confirm access to back up records, records

of the confirmation, records stored separate location from originals


What Was Added 8.8.1: Internal audits of LIMS shall be conducted at least once per

accreditation cycle Pre-Accreditation - Internal audits shall be completed for all parts of

the quality system for which the lab wants to become accredited Schedule and scope of audits determined on risk based assessment

8.9.1: Management review shall include a review of nonconforming work, customer and personnel feedback and complaints for trends


What Was Added

Appendix A: Equipment Balances shall be calibrated when moved to different location or

after repair Chromatographic systems (GC, IC, LC) verify detector response at

least once per batch Uniformity and stability after non-routine maintenance of

temperature controlled chambers Verify temperature at least twice daily, min 4 hr apart for

temperature controlled chambers used for testing


What Was Added

Appendix A: Equipment (cont) Reference temperature sensing devices/systems calibrated every 2

years instead of annually Water quality attributes monitored (pharma)

Dependent upon use


What Was Added

Appendix B: Microbiology Control organisms shall be checked for purity, enumeration and

demonstration of biochemical or other biological characteristics as appropriate for their application

Appendix C: Chemistry Acceptance criteria shall be defined in the method for calibration

curves, calibration checks, standard preparations, quality control samples, blanks, spikes, matrix spikes and duplicates


What Was Added

Appendix D Pharmaceutical Analysis New

Proficiency testing Evaluation and use of MU


What Was Added

Appendix E: Dietary Supplement Laboratories New

Documented plan for participation in interlaboratory testing or justify alternative plan for monitoring data

Fully documented chain of custody Equipment qualification


What Was Moved Procedure for subdividing, compositing, homogenizing to ensure a

representative test portion is taken for testing moved from sampling (old 5.7, new 7.3) to handling test items (old 5.8, new 7.4)

7.5.1 Technical records now included all records required for audit trail that were dispersed throughout the document

Procedures for use of handwritten signatures moved from reporting (old 5.10, new 7.8) to control of data and information management (old 5.4.7, new 7.11)

Qualification of water for lab use moved from environmental conditions (old 5.3, new 6.3) to equipment (old 5.5, new 6.4)


What Was Revised (AOAC 7.7.2) Pre-Accreditation: The laboratory shall have successful proficiency testing or interlaboratory comparison results to qualify each test method for which the laboratory wants to become accredited (see AOAC note).

(AOAC 7.7.2) Ongoing: The laboratory is required to demonstrate competence through the participation in proficiency testing based upon the scope they have (see AOAC note):

4/16/2019 17


What Was Revised/Clarified (AOAC 7.7.2.) for a Biological scope:The laboratory is required to participate in one proficiency testing event each year for each method on the scope.

(AOAC 7.7.2.) for a Chemical Scope:The laboratory is required to participate in one proficiency testing event each year for each method on the scope unless it can provide evidence in the form of additional justification showing the similarity of process between each of these methods.

4/16/2019 18


Notes Lots of new notes to help the laboratory understand the

requirements, how to apply them, and considerations to make the lab more defensible Ex. method validation, corrective actions,


FAQSWe did not account for every interpretation needing

explanation

Questions can be submitted to TDLM for interpretation

https://www.aoac.org/AOAC_Prod_Imis/AOAC/PUBS/ALACC/FAQs/AOAC_Member/PUBSCF/ALACCCF/ALACC_M.aspx?ALACCCCO=FAQs&hkey=0c0a5d71-d332-4985-93b3-a43afadf322e

https://www.aoac.org/AOAC_Prod_Imis/AOAC/PUBS/ALACC/FAQs/AOAC_Member/PUBSCF/ALACCCF/ALACC_M.aspx?ALACCCCO=FAQs&hkey=0c0a5d71-d332-4985-93b3-a43afadf322e


FAQSRequirement:In the ALACC Appendix A: Equipment table“ Temperature-controlled chambers used for testing.” ..monitored for temperature at least twice daily during its period of use. Includes ovens, incubators, water baths, etc.

Question:Does a heating block fall into that category? They are turned on at time of use only.

Answer:The philosophy in this section was that equipment left on all day needs to be monitored for temperature at least twice daily during its period of use. Essentially the same philosophy is meant for those pieces that are being used for a much more limited period of

time. However a single measurement might suffice for heat block (or possibly a measurement before and after usage if

the lab feels it necessary to demonstrate that the environmental condition was appropriate The number of measurements being dependent on the relative risk of the temperature not being at the desired set

point while it is in use for its function.


FAQSRequirement :Section 8.8.1: Internal audits of laboratory information management systems shall be conducted at least once per accreditation cycle.

Question:What information is required to satisfy this requirement?

Answer:The laboratory is required to audit the acquisition, transfer and data storage process in the LIMS, along with permissions for access to the various data to ensure only authorized personnel can access the different parts of the LIMS.


FAQSRequirementSection 6.4.4. of the Guidelines states “that reagents, reagent solutions, sample solutions, and internal reference materials [including certified reference materials (CRMS) used as internal reference materials] shall not be used past their expiration date without recorded verification that they are still suitable for use. Media and CRMS cannot be used beyond their expiration date. Note: Expired CRMs can be qualified as Reference Materials (RMS).”

QuestionWhen can an expired CRM be used?

ANSWER:A CRM is an RM characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides: 1) the value of the specified property, 2) its associated uncertainty, and 3) a statement of metrological traceability. When A CRM expires it loses a link to its uncertainty and traceability but still may be sufficiently homogeneous and stable with respect to one or more of its specified properties. Thus, a CRM that has passed its expiration date can still be used as a QC or as an RM if it is used in a manner that does not require the application of these two lost attributes as long as it is evaluated and re-qualified for suitability.


Summary

Revision was a group effort between industry, accreditation bodies and

persons from federal and state testing bodies

Removed some clauses to complement philosophy of ISO/IEC 17025:2017

Moved other clauses to new corresponding location in new std

Added specific requirements back to in lock in some “important” activities

Added some new areas related to DS and Pharma

Added many notes


Questions / Comments


Contact InformationRoger Brauninger5202 Presidents Court

Suite 220Frederick, MD 21703

301 644 3233

[email protected]

www.A2LA.org

2018 by A2LAAll rights reserved. No part of this document

may be reproduced in any form or by any means without the prior written permission of A2LA.

A Better World Through Accreditation

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AOAC Food Program Guideline Changes 2018 · 2019. 4. 16. · (AOAC 7.7.2)Pre-Accreditation: The laboratory shall have successful proficiency testing or interlaboratory comparison