September 10, 2012
In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.
Reasons for performing
In order to understand the reasons for performing Management Review it is worth pointing out a shift in emphasis in pharmaceutical Quality Management System (QMS) thinking. Thinking that has existed in many other industries for nearly 2 decades. This is the fact that the QMS should be owned by Top Management and not the Quality Assurance (QA) Manager or QA Department. It is the role of Top Management to lead an organisation, provide a vision, be clear on its direction and control the resources needed to achieve these objectives. Coupled with the fact that a QMS today should be aligned with business needs then Management Review is Top Management’s chance to review their QMS. One of the QA Manager’s roles is to operate the QMS on a daily basis and provide feedback on its performance to Top Management.
Where has it come from?
Management Review is not new to the general quality world. It was a requirement of ISO 9001:1994 and even standards before this. So it has been around for some time. It is also a requirement of later versions of ISO 9001, including the year 2000 and current 2008 versions. It is not currently (September 2012) a formal requirement of USA GMP (21 CFR 211) or EU GMP (Chapters and Annexes). It does though exist in more recent pharmaceutical Quality Management publications, namely the FDA’s Quality Systems Approach to GMP (published in September 2006) and ICH Q10 Pharmaceutical Quality Systems (June 2008). *
* Note – for a time ICH Q10 was expected to become Annex 21 of EU GMP, coupled with updates to some chapters, especially Chapter 1 on Quality Management. An update to EU GMP Chapter 1 is due in January 2013 and this does have the requirement for Management Review, therefore making it a GMP requirement in Europe. Recently both Annex 20 (Risk Management) and Annex 21 (Quality Management) have been moved to a newly created Part 3 of EU GMP. God only knows why!
What should be discussed?
Whilst both the FDA and ICH documents cover the need for Management Review I believe it is clearly described in the better worded FDA document. Going off at a tangent I do believe that ICH Q10 is one of the most poorly structured, muddled and unclear GMP document I have ever read! If you agree – drop me a “comment” at the end.
So what is expected to be discussed at Management Review?
The following is a copy from the FDA guidance document (from this point called their Quality System Model). My comments are in italic.
- The appropriateness of the quality policy and objectives [Are these still suitable for the organisation?]
- The results of audits and other assessments [What audits have you had or have you done? Any areas of concern? Any areas to praise? Anything to learn?]
- Customer feedback, including complaints [What do your customers think of you? Note – complaints is not the only thing that you should consider!]
- The analysis of data trending results [What data do you have on process performance and product conformity? Any positive or negative trends?]
- The status of actions to prevent a potential problem or a recurrence [How are we doing with closing down any Corrective Actions and Preventive Actions?]
- Any follow-up actions from previous management reviews [Actions outstanding from previous reviews]
- Any changes in business practices or environment that may affect the quality system (such as the volume or type of operations) [A great chance to be PROACTIVE! Let’s not wait for the “XXXX to hit the fan” (problems – if your English is not that great). Is anything going to change soon? New shift patterns, new equipment, new customers, etc. Think about the impact of these on the QMS and business now!]
- Product characteristics meeting the customer’s needs [Are we giving the customer what they want? Not only product of the right quality, but are we giving them what they want and when they want it?]
Outcome of Management Review
There is no point having any meeting if it achieves nothing! There needs to be action following Management Review. This is where it really can work. Outputs should include the following, again with my comments in italic.
- Improvements to the quality system and related quality processes [From the information that has been discussed – where are there areas where worthwhile improvements can be made?]
- Improvements to manufacturing processes and products [Are there any improvements that can be made to our processes and products?]
- Realignment of resources [Here is the beauty of Top Management performing these reviews – as they control the resources! In order to make the improvements stated above then what resources are needed to achieve these?]
Who should attend?
Well it’s pretty simple – Top Management should attend. For most sites this is the Senior Management Team who report to the overall head of the site. In other words, the Site Head along with the heads of (for example) Production, Quality Control, Quality Assurance, Human Resources, Finance, Research and Development, Information Technology, Planning, Engineering and so on. These are the people who run an organisation, who own the QMS and have the authority and resources to make changes as necessary.
[Note – I think in the USA these people are normally called Presidents or Vice-Presidents. We don’t have a lot of these here in the UK – what with us having a Monarchy and all that (joke)].
How often should they occur?
This is a very good question. ISO 9001, the source of Management Reviews, doesn’t state this. There is a brilliant sentence in the FDA’s Quality System Model that states two things. Firstly “when developing and implementing new quality systems, reviews should take place more frequently than when the system has matured”. This is very logical – more frequent reviews when underdoing changes and development of the business and system. There is also the following statement “outside of scheduled reviews, the quality system should typically be included as a standing agenda item in general management meetings”. This also beats ISO – no mention of this in ISO 9001. Here the idea of a range of reviews becomes an option, perhaps discussing certain aspects of the QMS at different levels and parts of the organisation at different times. This would certainly suit large and more complex organisations. What no standard states is a precise frequency, say every month, every quarter or every year. It is up to the organisation. From my own experience I don’t like to see Management Review performed just once a year – this is too long for it to really make a difference. I would also not want to see meetings for meetings sake. I am normally happy for a Management Review meeting between every 1 and 3 months. This generally allows time to gather useful data, take actions between reviews and even hopefully see the results of these actions at the next review.
I hope that you have found this useful. If you want to know more about our courses on GMP and Quality Management then visit our web-site. I have brought a bit of humour (or humor) into this – I hope it does not offend, it is not intended to.
Add any comments on this post, ICH Q10, the FDA’s Quality System Model and your thoughts on Management Review below.