{"id":1015,"date":"2020-02-10T16:21:06","date_gmt":"2020-02-10T05:21:06","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=1015"},"modified":"2020-07-29T14:30:51","modified_gmt":"2020-07-29T03:30:51","slug":"controlled-documentation-identifying-what-goes-into-a-policy-a-sop-and-an-oi","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2020\/02\/10\/controlled-documentation-identifying-what-goes-into-a-policy-a-sop-and-an-oi\/","title":{"rendered":"Controlled Documentation. Identifying what goes into a Policy, a SOP and an OI"},"content":{"rendered":"

The following is an article I placed on LinkedIn<\/a> and was written as part of my Developing My Writing While Helping Others<\/em> series.<\/p>\n

I am a microbiologist with over 15 years\u2019 experience in the pharmaceutical realm.\u00a0 I have a strong interest in regulatory compliance, documentation and developing others.\u00a0 Recently I have been working closely with data security.\u00a0 I have an arty streak, have developed and delivered training and have an affinity for computers.\u00a0 I ride bicycles\u2026a lot.<\/p>\n

Controlled Documentation.\u00a0 Identifying what goes into a Policy, a SOP and an OI<\/p>\n

Introduction<\/h1>\n

Within a regulated environment, there are multiple levels of documentation.\u00a0 The purpose of such documentation is to ensure work is carried out in a legal, regulatory complaint and consistent manner.\u00a0 These documents must be clear, not open to interpretation and justified in their content.\u00a0 There are three levels of controlled documentation.\u00a0 Policies, Standard Operating Procedures (Procedures) and Operator (or work) Instructions.\u00a0 Each type of document serves a specific purpose and needs to contain relevant information.\u00a0 Here I discuss the three levels of documentation and identify the purpose of each and the information each should contain.<\/p>\n

The Three Types of Documentation<\/h1>\n

Within a controlled documentation system, a hierarchy of documents is advantageous.\u00a0 In the companies I have worked for, there have typically been three.\u00a0 Policies, Standard Operating Procedures and Operator (or work) Instructions.\u00a0 Each document has a specific purpose and contains specific information.<\/p>\n

The Policy<\/h2>\n

A high level document that generalises what goes on. \u00a0\u00a0These documents contain regulator information (or references to the information), internal polices, rules and principles and why they are in place.<\/p>\n

The Standard Operating Procedure (SOP)<\/h2>\n

This document describes overarching areas, such as Bacteriology, the Viable Environmental Monitoring Program, Site Validation, and Sterility Testing.<\/p>\n

A SOP details a series of tasks that takes place over time with an identifiable goal.<\/p>\n

As an example, a bacteriology SOP would bring together everything to do with this subject including plating, identification, maintaining a culture collection with the aim (perhaps) to allow staff to identify and maintain microbes.<\/p>\n

The language in this document should be clear and not open to interpretation.<\/p>\n

The Operator Instruction (OI)<\/h2>\n

This is the lowest level of documentation and describes a specific process that usually can fit on a page or two and has a specified outcome.\u00a0 Examples based on the subjects listed in the SOP section above include for Bacteriology: Perform a Gram Stain, for the Viable Environmental Monitoring Program: Operation of the MAS100 Air Sampler, for Site Validation: Validate A New Incubator and for Sterility Testing:\u00a0 Sanitise the Isolator with Hydrogen Peroxide.<\/p>\n

Using the Perform a Gram Stain example, this would detail the step by step process for taking a colony off a plate and staining it using the Gram stain method.<\/p>\n

What Information goes in each document<\/h1>\n

A policy explains the reasons behind a process.<\/p>\n

A SOP provides the who, what, where when and order of something. If a process takes more than a day (generally) then a SOP is the appropriate document to write.\u00a0 A SOP might be used by more than one person at a time.<\/p>\n

An OI is more time limited than a SOP and the task the OI details is normally conducted by a single person at a time.\u00a0 Steps that may be generalised in a SOP are specifically stated within a OI.\u00a0 Do this.\u00a0 Do that.\u00a0 Do this other thing.<\/p>\n

Document Structure<\/h1>\n

Like any well planned writing, a logical structure is important.\u00a0 All documents should have a header and footer containing such information as writer, verifier and approver, approval and expiry dates, document number, title, page number and total pages.<\/p>\n

A policy could be set out as follows:<\/p>\n

Purpose, Background, Roles and Responsibilities, Overview, Listing of related polices, Glossary, References.<\/p>\n

A SOP could be set out as follows:<\/p>\n

Purpose, Who uses the policy, EHS considerations, Before you begin, Procedure, Additional information, Glossary, References.<\/p>\n

An OI could be set out as follows:<\/p>\n

Purpose, Who uses the OI, Before you begin, Overview, Instructions.<\/p>\n

Other Considerations<\/h1>\n

Templates<\/h2>\n

Useful for providing consistency of format and providing examples of acceptable content. A template ensures consistent document structure and formatting of titles, headings, body and table content.<\/p>\n

Scheduling and Planning<\/h2>\n

Used alongside document validity dates.\u00a0 Enable the documentation controller and users to proactively schedule document review and update. Planning is important so the document is updated without rushing (i.e. the week before it is due to expire).<\/p>\n

Who Writes the Documents<\/h2>\n

The subject matter expert (SME) is the best writer.\u00a0 Don\u2019t be afraid of delegation however. A technical writer can be used provided the document is written in consultation with the SME.<\/p>\n

Who Reviews and Approves Documents<\/h2>\n

The reviewer should be a peer or someone in the management chain for the writer as they should also have knowledge of the process being documented.\u00a0 The reviewer looks for content accuracy, correct grammar and correct references.\u00a0 Ideally, the writer does the review and a verifier is used to confirm the work of the reviewer.\u00a0 This reduces work for both the writer and the verifier as the document does not have to keep going back and forth between the two.<\/p>\n

The Approver will ideally be the manager of the department responsible for the process being documented.<\/p>\n

Change History<\/h2>\n

It is very important to track changes and document the reasoning behind changes.\u00a0 Helps an auditor to identify and approve changes.\u00a0 In my view, this section can never contain too much information.<\/p>\n

Training<\/h2>\n

Staff need to be trained to follow SOP’s and OI’s and when a significant change to a SOP or OI is made, your staff need to be trained in the changes.<\/p>\n

Standard Procedure for Documents<\/h2>\n

In order to produce consistent documentation with sensible content in a consistent format, procedure for doing this is helpful and within a regulated environment, a necessity.<\/p>\n

Conclusion<\/h1>\n

You will now be familiar with the three main types of controlled documents: Polices, SOPs and OI\u2019s, when they are suitable for use and what sort of information each type of document should contain.<\/p>\n

\u00a0Appendix<\/h1>\n
\"\"<\/a>

Summary table of the types of information that goes into a SOP and an OI<\/p><\/div>\n

Did you find this informative or useful? Please consider a small donation so I can expand and improve on what I deliver.<\/strong><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series. I am a microbiologist with over 15 years\u2019 experience in the pharmaceutical realm.\u00a0 I have a strong interest in regulatory compliance, documentation and developing others.\u00a0 Recently I have been working closely with […]<\/p>\n","protected":false},"author":1,"featured_media":1044,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,5,17],"tags":[29],"class_list":["post-1015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-advice-provided","category-documentation","category-how-i-benefit-you","tag-documentation"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/comments?post=1015"}],"version-history":[{"count":9,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1015\/revisions"}],"predecessor-version":[{"id":1194,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1015\/revisions\/1194"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media\/1044"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=1015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=1015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=1015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}