by: farzad dadgari soil and environmental specialist swhisa

By:

Farzad Dadgari

Soil and Environmental Specialist

SWHISA

SOP is a clearly written set of instruction or methods detailing the procedures for carrying out a routine or recurring task or study.

SOPs are used to describe both administrative and technical tasks.

As a management tool SOP:Provides a foundation for training new

employees by establishing operating procedures;

Serves as a continuity tool where regular personnel are absent, enabling others to carry on the function;

Helps maintain QC by providing detailed step-by-step guidance to personnel in carrying out a certain procedure;

Describe study methods that are adequate to ensure the quality and integrity of the data generated in the course of study; and

Provides a documented, historical record of an organization’s operating procedures during specific period of time.

As an administration tool it can be used to:

Decide where in an organization a procedure should be carried out;

Decide what material and personnel resources are required; and

Outline the manner in which procedures are to be carried out.

Review your procedures & decide what should be explained in SOP. Seek input of personnel who have experience in the procedure;

Collect info on the procedure from references. Contact other organizations performing similar functions and request for their SOPs (if they have one) and modify it to suit your lab’s needs;

Assemble all blank forms and other documents you will need to reference in the SOP; Assign the SOP a number and title for ID and referencing;

Write a draft of the SOP, following the guidelines provided in this presentation;

Review the draft SOP for technical adequacy & administrative accuracy. Make sure SOP is written clearly and is easy to follow;

The SOP should answer the question: who, what, when, where, and how:

Submit the draft SOP for peer review & supervisory approval;

Incorporate proposed changes in final version, sign and date the final version. File a copy.

Follow the format for administrative and technical SOPs, provided in the handout;

Divisions of SOP (paragraphs, sections, chapters), figures and tables should be numbered for ease of referencing;

If SOP is longer than 10 pages, a table of content should be prepared;

Content of SOP should be:Clear, concise, and thorough,

especially when listing step-by-step procedures;

Assume person using the SOP has no previous knowledge of the procedure;

Greatest enemy of a good SOP is vagueness and imprecision. SOP is of no use if no one can understand who should do what;

Include only those steps that needs to be followed within immediate organization;

Be comprehensive, but do not include irrelevant matters; and

Be positive in your presentation.

Only include appendixes (at the end of document) that are necessary to finish additional or supplemental material, say sample contract or list of references;

Provide glossary only if the SOP has more than 15 abbreviations;

Use illustrations only when they are essential and contribute to a cleared understanding of the subject matter and reduces the writing part of the SOP.

When a number of SOP is prepared, incorporate them into an SOP manual;Place individual SOPs in a large

binder, sorting it into chapters by subject matter;

Arrange chapters in a logical sequence, say administrative in one and laboratory procedures in another;

Develop a ToC in front of the binder;

Place the SOP manual with other references such as QA/QC manual , analytical and technical guidelines;

Maintain a historical registry for laboratory procedures;

The supervisor must maintain a historical file of obsolete laboratory methodologies and SOPs and revisions for future reference;

At least one copy of discontinued procedures should be filed in a binder and kept close to SOP manual;

Record the following info and attach to the SOP cover:

This SOP/ laboratory methodology was in effect for the period of ….. (original effective date) through (date when SOP was removed from service). This SOP was replace by SOP … (give the SOP number, effective date and title of new SOP).

Supervisor should review the SOPs at least once a year to ensure the procedures are up-to-date, reflecting the change in work environment;

If no changes are needed, the reviewing person should sign and date a cover sheet and attach it to the file copy of the SOP;

If procedures change. Rewrite the section. Newly added material should be

identified by asterisk;If a paragraph is withdrawn (rescinded),

delete the body of the paragraph but keep its original numbering and title in its original place in the text.

Mark the paragraph with an asterisk and write “withdrawn” or “rescinded” in parenthesis after the title;

Prepare a memo to transmit the revised SOP to the users, indicating the number of changes and the number f changed pages;. Attach the memo to the file copy of the SOP.

If changes are extensive, revise the entire SOP and follow steps for preparing a new SOP.

One person should be mandated in the laboratory to:Assign SOP numbers for identification

purposes;Know how many copies of SOPs exist for

good control, management, and revision;Verify that all collected SOPs in the lab:

Are updated and evaluated for being up-to-date, at least annually;

Concise cover sheets to allow the supervisor to review the SOPs.