Document Control & Change Control: Periodic Reviews & Retraining
Document Control - 16 March 2016
Our previous blog in the Document Control Series covered the various and incremental ways companies choose to do document reviews and change control, and the strengths, weaknesses and future predictions for the evolution of each;
This blog discusses our current thinking, as it has evolved from 15 years working with clients on periodic reviews of controlled documents, along with the accompanying re-training requirements.
Periodic Reviews of Standard Operating Procedures (SOPs)
Although the periodic review of controlled documents, such as SOPs, is not a regulatory requirement, it is certainly a very common and recognized best practice in the Life Sciences industry. It is also a fact that Regulatory Investigators will immediately question the robustness of a quality system that has not updated its procedures in several years.
The most common review period used by companies in the Life Sciences industry ranges from two to three years. Most companies recognize the value of a specific periodic review requirement.
It is important to note that the periodic review requirement is also generally applied to other controlled documents, such as Work Instructions or SOPs. Periodic reviews must be documented, even if the content of the document itself does not change.
"To manage [periodic review requirements], a periodic retraining curriculum should be established for each position in the company... and list the major SOPs/controlled documents."
I can’t emphasize enough how important the company’s culture, and the example that supervision and management sets, is in ensuring the quality of the end products. These factors, along with the results of internal audits, external audits, inspections and the trends seen from root cause analysis performed for deviations, are all indicators of the quality system performance and the quality culture of the company.
All of the above factors can be used to determine and justify the frequency of SOP review and employee training. For example, if the root cause trend analysis mentions ‘not following the procedure’ or ‘procedure is incorrect or lacks sufficient detail or clarity’, then I think you should look at your SOP system and employee training system. They might need a CAPA!
Regarding Training & Periodic Reviews
When a controlled document, such as an SOP, is revised, the need for retraining of employees who have the SOP listed in their training curriculum should be determined, based on the change, and then documented. For example, spelling, grammar, formatting or minor wording changes (all cosmetic changes) would not require retraining of employees. The revision number of the SOP would change, but retraining would not be required.
For certain positions in the company, frequent retraining and recertification should also be required; these are the jobs that have the most potential to impact the quality of the products. It is important to understand that this retraining and recertification requirement is different than the general requirement as described in the previous paragraph.
Philippe Gaudreau’s passion for process automation led him to found SOLABS in 1999. Since that time, he has become a subject matter expert in electronic document control and training management and regularly lends his expertise to SOLABS’ clients.
To manage this, a periodic retraining curriculum should be established for each position in the company. The periodic retraining curriculum should list the major SOPs/controlled documents, even if the SOPs/controlled documents have not changed, and GMP topics that should be reviewed every year with the employees. Some curriculums will be short and others will be quite extensive. For example, an operator in a cleanroom might have to go through a comprehensive recertification program, while a material handler in the warehouse might only have to attend a GMP refresher classroom course. This assures that employees remain sufficiently familiar with CGMPs directly related to their duties, and the specific job requirements that have the most potential to impact the products’ SISPQ as required by the regulations.
By adopting the above recommendations, companies will have a training system that is compliant and efficient—where it relates to training on controlled documents. Employees will feel that their training is adding value and is important in helping ensure the quality of the products they develop or manufacture. The periodic review itself is important, but the training details arising from it are even more so.