Lean Documentation 1: GLP, GCP, GMP, SOP, too many documents ?
SummaryPharmaceutical companies are renowned for exhaustive pages of regulatory reports and documentation procedures. An enormous amount of effort goes into creating and maintaining these documentations, usually by people for whom it is only a small part of their job. Another problem is that complexity exists in such documents and may be due to an excess of information or to inappropriate structure. Again, historically there may have been a drive to put every little detail into the procedures, in t
Documentation is the backbone of the pharmaceutical industry – the taken-for-granted support for GLP, GCP, GMP and many other regulations. We have to document what we do, how we do it, the expected result, the actual result, what went wrong, what we did about what went wrong, what we change, how we know the change was effective, and so on. An enormous amount of effort goes into creating and maintaining this documentation, usually by people for whom it is only a small part of their job. Yet, among all of today’s initiatives to streamline operations, it is extremely rare to find any effort being put into improving and streamlining the documentation, particularly in the manufacturing sector. Why is this? I believe that the common view is that the amount of effort required to re-create documentation isn’t justified by the perceived return – it’s simply a business decision.
But think about this. Inefficiencies can be introduced into an otherwise lean business by considering documentation as a necessary evil and failing to realise its potential as a business improver. And almost every FDA Warning Letter that follows a site inspection cites ‘failure to follow procedure (or protocol)’. The common response is to ‘retrain’. But it’s as likely to be the document itself that’s at fault as the individual or their training programme.
The common issues I see with documentation are as follows:
• there’s simply too much – too many SOPs, too many memos;
• it’s too complex, so is difficult to follow (instructions/protocols) or to find the required information (records);
• the format is inappropriate;
• it’s poorly managed, usually because the control systems are cumbersome.
Let’s look at each of these more closely -- how do they affect compliance and, ultimately, your business?
Too many documents
It’s obvious, isn’t it? The more documents you have, the more time you have to spend managing them: filing, retrieving, updating, reviewing, approving, etc. It’s sometimes the case that, historically, those with a keen interest in compliance have driven the generation of documentation to cover every eventuality, with the misconception that this means they have more control over their quality systems. But the reverse is true. The more documentation there is, the more difficult it becomes to keep under control or to extract the required information.
If you can reduce the number of documents to a more manageable quantity, you free up your staff for other activities and you reduce the chance of losing control.
Complexity in documents may be due to an excess of information or to inappropriate structure. Again, historically there may have been a drive to put every little detail into your procedures, in the hope that it will ensure that your end users follow them to the letter. But, again, the more detail you include, the more likely it is that, at some point, a user won’t be doing exactly what is required. It’s a very easy hit for an auditor. Even if the end user’s activity is perfectly acceptable in terms of the result, if s/he is not following your SOP to the letter, you’re in trouble.
The other problem with long or complex documents is that they are daunting. No-one wants to trawl through pages of dense prose to find the information they need, so users will skim-read the material and will therefore miss important information – this is a common cause of the ‘failure to follow procedure’ so often observed. And it won’t be resolved by retraining.
If your users have to record information, for example during qualification or batch production, they are less likely to make a mistake if the document (paper or electronic) is formatted in such a way as to make it entirely clear:
• what information is required
• the required format of the information
• where information is missing.
This may seem obvious, but there are a number of formatting subtleties that can make a big difference to the usability of the document; some of these will be covered in a future Field Report.
What about physical format? How big is the document? Very bulky documents are difficult to handle and are more likely to become damaged. Is paper suited to the work environment or will parts of the document be illegible after a few days’ use? Is the information all in one place or spread across several documents? If you are serious about your documentation, these questions are as important to your business as an efficient and compliant process.
Do your document management systems work? Are they efficient and well-controlled? If not, are you going to admit it? A site was proud of its SOP management system: apparently it had been praised by auditors. But actually it was extremely cumbersome with multiple points at which there was opportunity for human error, and hard copy control was labour-intensive. The system was holding the site back, and it wasn’t helped by the excessive number of SOPs they were managing. (Incidentally, their batch records were extremely well managed: it is possible to have both good and bad systems on one site!) If your document management systems work well, document control and information retrieval will not be the rate-limiting steps in your process improvements. A well-oiled system will support, not detract from, your other activities.
Although your documentation may seem perfectly adequate for the job, there are several factors that could be adversely affecting your business. The problem is that few sites have either the required skill sets to produce high-quality documentation, or the budget: it’s rarely seen as a high priority. I hope that some of the points in the article may persuade to look at your documentation from a new perspective; I also hope that subsequent articles will help you to start making changes.
This is the first in a series about “Lean Documentation” but watch this space for the latest reports from the PharmiWeb Field Reporters in a wide variety of topical subjects…”
To see the next feature in the series by Joanna Hills follow these links:
Lean Documentation - System Analysis Part 1
Lean Documentation - System Analysis Part 2