WRITING EFFECTIVE STANDARD OPERATING

PROCEDURESBeth Thompson

Shealy Consulting, LLC.October 23, 2019

DO YOUR SOPS LOOK LIKE THIS?

…OR THIS?!

DHEC PUBLICATION!

SCDHEC SAYS SOP’s….• Are written instructions on how to perform a

specific analytical method and/or task in the field or laboratory.

• Are used to explain how to collect a sample and preserve it to maintain the sample integrity.

• Must explain all aspects associated with an analysis.

DURING AUDITS YOU WILL LEARN THAT SOP’S ALSO…

• Should be available for every activity performed on a regular basis in the laboratory

• Must be available for every certified parameter• Must actually represent what is being done in the

laboratory• Must be signed and implemented by analysts

responsible for the procedure

PARADIGM SHIFT:

STANDARD OPERATING PROCEDURES SHOULD ACTUALLY

MAKE LIFE EASIER!

THE ‘WOW, LIFE IS EASIER!’ TEST

When asked a method question, do you refer the analyst to the SOP? Does the analyst quietly resolve the issue and

continue workingDoes the analyst return to your office holding

the SOP and looking more confused than ever?

BEFORE YOU START:

Think:• What is the new method

number?• What QC elements are

required?• Is all of my equipment

information up-to-date?• Do I need any new

equipment or supplies?• What template do I want to

use? Standardize it.

TECHNICAL METHOD SOPS

• Scope and Applicability• Summary of the Test Method• Definitions• Health and Safety• Interferences• Sample Handling, Preservation, and Storage

TECHNICAL METHOD SOPS

• Instrumentation and Equipment• Reagents, Standards, and Consumables• Standard and/or Reagent Preparation• Instrument Calibration and Standardization• Sample Analysis Procedure• Quality Control

TECHNICAL METHOD SOPS

• Data Reduction, Validation, and Reporting• References• Waste Management• Revision History• Tables, Diagrams, Flowcharts, Validation Data

From SCDHEC, Procedures for Chain-of-Custody SOP Development, and Common Field Parameter Measurements, March 2018

COVER PAGE

• PARAMETER NAME• EPA APPROVED METHOD REFERENCE• SOP VERSION AND EFFECTIVE DATE• AUTHORIZED SIGNATURE• CONTROL INFORMATION

SCOPE AND APPLICABILITY

• Identification of the method• Correct EPA or Standard Method numbers• Applicable matrix or matrices• Limits of detection

SUMMARY OF THE METHOD

• Provide a brief explanation of the procedure• Include when the method is used

DEFINITIONS

• Define common abbreviations• Define acronyms• Define terms specific to the analysis• Define QA/QC terms

HEALTH AND SAFETY

• Very important!• Can refer to a general safety plan, but include

specifics for this method.• Include method-specific chemical warnings• Include method-specific PPE to be used• May want to include the requirement for analysts

to locate and read the applicable chemical SDS (Safety Data Sheets)

• Explain what could happen if safety procedures are not followed.

INTERFERENCES

• Include any matrix characteristic that may impact or prevent a successful analysis

• Include preventative measures or treatments for interferences.

• Anticipate problem areas and common issues.• Include physical or chemical properties of the

sample.

SAMPLE HANDLING, PRESERVATION, AND STORAGE

• Include any information that is necessary to maintain the integrity of the sample

• Include holding times and container types• Include thermal preservation, if required• Include storage conditions• Refer to chain-of-custody procedures, if needed

INSTRUMENTATION AND EQUIPMENT

• Include all instrumentation necessary to perform the analysis.

• Specify the manufacturer and model number of all instruments.

• Include routine maintenance requirements• Include troubleshooting for problems• Include instructions for repairs that analysts

can perform• Include instructions for notifying the person

responsible for handling more serious repairs

REAGENT AND STANDARD CONSUMABLES

• List all reagents that may be used• Include purchasing information for reagents• Include approved reagent substitutions• List all standards, including purchased standards

and chemicals required for preparing them in-house

• Note if standards should come with a Certificate of Analysis (COA) to support traceability

STANDARD AND/OR REAGENT PREPARATION

• Include detailed instructions to prepare reagents• Include reagent expiration criteria• Include standardization procedures for reagents

and the frequency performed• Include detailed instructions to prepare

standards• Include standard expiration criteria • Include storage criteria for both reagents and

standards

INSTRUMENT CALIBRATION PROCEDURES

• Include calibration instructions• Include calibration verification

instructions• Include calibration frequency• Include acceptability criteria• Include instructions for performing

corrective actions if calibrations or calibration verifications are out-of-range.

PROCEDURE

• Step-by-step • Be specific• Don’t be too specific• Get analyst input about what is really happening• Must actually be followed by the analysts!

DON’T RELY ON MIRACLES!

QUALITY CONTROL

• Check three parts of the Standard Methods 22nd

Edition for all required QC elements.• Check the SCDHEC Manual, 2018• Include frequency of QC elements• Include acceptance criteria for QC elements• Include Corrective Action Plan for Out-of-Control QC

DATA REDUCTION, VALIDATION, AND REPORTING

• How are sample results to be reported (units and decimal places)?

• List instructions for computer software to be used, if needed

• List instructions for entering data into a system• Include mathematical steps to be followed• Include simple calculations, don’t assume anything• Include QC calculations• List reporting procedures

RECORD OF REVISIONS

REVISION #

REVISION DATE SECTION REVISION PROMPTED BY

1 8/8/2011 1.2, 7.5, 9.3, 10.2

Daily calibration should be on 0.05 ppm and 0.1 ppm standards, not 0.5 and 1.0 ppm standards.

Quality Manager

2 01/01/13 Title Page,References

Method references revised to SM4500ClG-2011

Standard Methods 22nd Edition

2 01/01/13 ALL Revised sections to comply with TNI 2009 TNI 20092 01/01/13 10, 11 Added QC as required by Standard Methods

22nd EditionMUR II, DHEC

3 02/01/13 10 Daily check on 1.0 ppm standard instead of 2.0 ppm standard

Better reflection of our range

4 04/06/13 7, 10, 11 Changed standard from potassium permanganate to traceable HACH chlorine standards

Quality Manager

5 10/11/13 11 Removed unnecessary QC elements SCDHEC 20136 04/07/14 Title Page Technical Director and Quality Manager

updatedTechnical Director

REFERENCES

• All references that may be helpful for conducting the test method.

• Instrument manuals.• Other SOPs for support activities• Standard Methods references or other

procedures that were used to create the procedure.

WASTE MANAGEMENT

• Does the method have any modifications that help to prevent negative environmental impact?

• Do any of the waste products generated in the method require special disposal procedures?

• How do you dispose of extra sample? Do you need approval from local sanitary sewer systems?

• What to do with broken mercury thermometers?

STRAIGHT FROM LAB CERTIFICATION…

Not following procedures in your SOP will be a finding!

SOP APPROVAL AND CONTROL

SOP REVIEW/VALIDATION

• Have the draft SOP tested by analyst other than the original writer before the SOP is finalized.

• Have someone not directly involved in the method review it as well.

SOP REVIEW/VALIDATION

• Have all analysts read new or revised SOPs and sign an SOP Agreement log prior to the effective date of the SOP revision, or BEFORE they perform analysis again.

• Having the analyst sign the SOP as a part of the IDOC should be a requirement.

SOP REVIEW/VALIDATION

• Have analysts and management review the SOP on a periodic basis, e.g. yearly– Ensure that the policies and procedures remain current– Determine whether the SOPs are even needed– Make sure the laboratory is actually doing what the

procedure says

SOP REVIEW/VALIDATION

• Have an SOP control logbook (electronic or paper) to keep up with the most recent revision and to be sure all old revisions are replaced.

• Each copy you print is a controlled document, and needs to be listed in your logbook.

• Uncontrolled copies may be distributed to DHEC, etc., but also need to be listed in your logbook.

NUTS AND BOLTS

• Whenever procedures are changed, SOPs must beupdated and re-approved.

• Hand corrections may be added until the revision is updated.

• If the SOP describes a process that is no longer followed, it must be withdrawn.

• You can’t just stop doing a step or change a procedure!

• Have an SOP for creating and publishing SOPs!

THE WELL-PREPARED ANALYST!

Beth Thompsonbthompson@shealyconsulting.net

www.shealyconsulting.net