A colleague in Canada reports that new Canadian blood safety standards (CSA Standard Z902, still in draft) require that there be criteria for when a change to an SOP should cause an SOP to have an updated version number. The inquiring Canadian wants to know if any colleagues have criteria for when an SOP's version number should be changed versus merely making a minor change without a version number adjustment? Does anyone know of a website or reference where such criteria can be found? According to the Canadian, the draft CSA Standard implies that some revisions do not require a change in version number. If so, how would colleagues handle minor changes, while maintaining document control?

The following responses were received.

1. A technologist and blood bank supervisor in Los Angeles reports that based on the limited information given, it appears that the draft Canadian standard requires only that there be criteria for when a change to an SOP should cause that SOP to have an updated version number. It does not appear that a specific set of definitions be followed. Thus, he is of the opinion that it can be left completely up to the discretion of a laboratory to define what they consider requires a version change, such as not updating the version number for a minor SOP change versus updating a version number with a major change in an SOP. Once defined, it obviously follows that the lab must abide with what they have written and update version numbers accordingly. At the Los Angeles colleague's facility, a major change requires an updated version number whereas a minor change does not. Below are examples from their SOP as to what constitutes a minor vs. major change.

Minor Change:

• Correction of a typographical error
• Change in stocking levels of blood products, reagent or supplies
• Change in the content of an SOP that does not significantly influence the performance of a process or assay, or the safety, potency, or purity of blood products.

Major Change:

• Critical change of a test (e.g. change in testing methodology
• Change in the content of an SOP that significantly influences the performance of a process or assay or the safety, potency, or purity of blood products
• Change to fulfill regulatory or compliance requirements.

ADDENDA June 11, 2003

2. A colleague in Cantabria, Spain reports that he fully agrees with the criteria proposed by the colleague in California, including the concept that every center should be able to define what is a major or minor change. He reports that when his center became ISO 9002 certified, they had to standarize their procedure for SOP changes. In order to minimize version numbers, save paper, and time the following system was applied:

• When major changes in SOP are needed (new reactives, new machines, radical changes in the practice), they create a new edition.
• Tiny changes (misspelled words) are corrected by hand and signed.
• For other changes, they include in every SOP a "modification page", a blank page placed after the SOP title page. Changes are included in this page when they become necessary and a stamp "see changes" is put in the main text of the procedure, where the text should be changed. Changes have to be reviewed and approved the same way as the SOP. Yearly revisions of the SOP are also included in this page, stating whether changes are made or not.
• Only when the modification page is full, a new edition is made, the changes are included in the text and the modification page is blank once again.

This has saved us a lot of paper, time and work.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator