The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this says more about the quality of the SOPs in the organisation than the usefulness of well documented procedures.
The hidden costs of poor documentation are significant:
- Key personnel are involved in writing, reviewing and training each procedure
- Operators are out of operations when they undergo training so the down time should have a return in both quality and efficiency
- Administration costs for documentation include distribution, recall, retention and destruction
‘Clause 4.2: Documents should be designed, prepared, reviewed and distributed with care.’
PIC/S Guide to Good Manufacturing Practise for Medicinal Products (PIC/S Guide to GMP)
It is in a company’s interest to ensure their procedures not only ‘tick a compliance check-box’ but provide valuable business tools for training, business sustainability, and evidence for 3rd party audits to demonstrate control of complex business processes.
1. Tabulate, bullet and number
‘Clause 4.4: Documents containing instructions should be laid out in an orderly fashion and be easy to check.’ PIC/S Guide to GMP.
No-one likes to read a slab of dense text. Format your procedures so that information is easy to read and reference.
- Tables are a quick way for writers to sort complex data into easy to reference format.
- When the order of events are critical use numbers.
- Use bullets to help break down information so key points are laid out methodically.
2. Watch-out for indented numbering
2.1 I suspect it comes from academic papers but indented numbering is the nemesis of well formatted SOPs.
2.1.1 When incorrectly formatted, indents creep across the page and steals line length making documents disjointed and difficult to read.
126.96.36.199 By using tables and numbered bullets you can achieve the same quick reference result.
3. Does your SOP template guide the writer and end-user?
‘Clause 4.30: Clear operating procedures should be available for all major items of manufacturing and test equipment.’ PIC/S Guide to GMP.
Standardised format helps documents become clear, user friendly reference tools. End users learn quickly when every document is written in the same structure and style, and they have the confidence that they can consistently locate the information they are looking for in their documents.
Well designed templates also reduce the opportunity for document authors to change formatting to suit their personal preferences and spend time ‘tweaking’ styles.
Do your SOP templates contain standardised headings for:
- Roles and responsibilities
- Process overview
- Terms and Abbreviations
- Reference section including prompts to reference the underpinning codes and standards
- Change history
4. Write for the end-user
‘Clause 4.4: The style and language of the document should fit with their intended use.’ PIC/S Guide to GMP.
If the process describes ‘Set-up of the XYZ’ then Step 1 is what your end-user wants to see up-front!
I recently reviewed an SOP in which the process description did not start until page 7. The first 7 pages were used as a platform for the document authors to demonstrate their back-ground knowledge. Use training documents for extra information if the SMEs feel it is relevant, or even an article in the company newsletter, but stay focused on when, where and how the SOP will be used.
Write for the user, not yourself.
5. Test drive your SOPs
‘Clause 4.3: Documents should have unambiguous content…’ PIC/S Guide to GMP.
Considering the cost of preparing, reviewing and administrating SOPs, finding out in training that the SOP has a fundamental process flaw is too late.
If the document writer does not routinely perform the process then the process should be ‘test driven’ by the people who perform the activity prior to final approval. This check allows the logical flow of the document to be trialled by the people who will do the process routinely.
6. Embrace white space
In an attempt to reduce page numbers some companies reduce font sizes, margins and paragraph spacing so they can get more text per page. The result of this cost saving strategy is unreadable SOPs that cannot be used in situ because the writing is too small and key information lost.
7. Have a clear document hierarchy
Clause 4.1: ‘Relationships… need to be stated…’ PIC/S Guide to GMP.
The relationship of SOPs, instructions, forms and lists should be clearly indicated within each document so that users can understand how associated documents are related to each other and where to access process or instructional information. This relationship may be achieved via a numbering system or simply through a statement such as ‘Overriding SOP ABC.’
8. Make the most of the Document Change History
This is one of those hot discussion points: How much information should go into the Change History within the document?
The Change History within the document should:
- Allow all users to quickly summarise the scope of the change but should not replace the need to read the document in its entirety.
- Ideally reference the change control number so that anyone wanting to trace the full change justification back to the original change request.
- Identify when a change in a past version may have occurred therefore which version may need to be retrieved from archival.
9. Write in ‘active language’
Clause 4.4: ‘Standard Operating Procedures, Work Instructions, and Methods should be written in an imperative mandatory style.’ PIC/S Guide to GMP.
Imperative words are verbs used to give instructions, commands, warning or direction.
Look at the bulleted actions above, the placement of the underlined verbs at the beginning of the instruction makes the use of the verbs in these sentences imperative. How does this help the reader? By providing clear, unambiguous instructions people know what is required of them. By making instructions mandatory the opportunity for deviation is reduced.
In the above bulleted list the use of the word ‘ideally’ makes the instruction non-mandatory, leaving it open for readers to decide if they want to add the change control number or not. If this was an SOP ‘ideally’ would be deleted.
10. Join the global Plain Language movement
Most people think they write well however companies full of poorly written procedures indicates otherwise. Communicating in plain language is the art of saying what you mean clearly. Good writing means your readers can:
- take in information in one reading
- comprehend written instructions effortlessly because information is laid out logically, clearly and concisely.
To learn more about good writing skills check out this great website including, before and after examples of Plain Language in action (you will even see the FDA showcased!).