Management Review

Alice June

Management Review meeting involving key decision makers in the laboratory especially in Government laboratories has been illusive and yet getting their involvement is the key QMS sustainability and actual accreditation of the labs. Please share ways and ideas on how we can achieve this to ensure their involvement in the MR

Janet Scholtz

To Alice

This is a difficult situation but there are a few ideas. The main thing is to get the top management to understand their role and what the requirements from them are in the standard.

a) The quality manager should be reporting to the person who makes the decisions - see clause 4.1.2.7 (b) needs to have a meeting with the laboratory management to explain their role, you may want to do a presentation explaining clause 4.1 and 4.2 and then how the MRM fits in and you can use the Burnett model to show them where they fit in. You have to be persistent in your approach.

b) You could send them for training on the requirements of the standard - if there is a process where managers go on training you can use that process. I do find that the training suppliers for ISO 9001 usually have a top management course, which may be useful if not specific to ISO 15189.

c) Set up MRM output meetings with the top managers so that they dont have to sit through a whole meeting e.g do the review and then take the decisions that they are required to make to them for action. If you have time, then do quarterly reviews or 6 month reviews.

d) There is also CLSI guidelines that talk to leadership in QMS. I am not sure if you have access to these documents.

Ritu Shrivastava

1. You could present major output requiring top managers attention at their meeting involving lab manager
2. Send the output as a memo/bulletin to management stating what the issues are, what is required and responsible person(s) with a duplicate signed as evidence of receipt
3. Work with top management to include periodic meeting in monthly activity calendar

Philemon Pickson Ndhlovu

I agree with Janet and Kingston in this summary:

• there has to be commitment and understanding from management on MR. clauses 4.1 and 4.2 are indeed essential for their participation during this process.
• Just sending them a report for their action would work to our disadvantage because they could easily treat it like any other request through their office and they do receive tonnes of requests from all departments
• In cases where top management are continuously engaged and give apologies to attend MR meetings, there was a novel idea to boost their participation even when not physically being at one place. EMAILS THREADS.
• The laboratory will prepare a quality based on 4.15.2 and circulate to all officer bearers mentioned in the laboratory MR SOP. The comments and responses are discussed in the email thread. Decisions arrived at tasked to personnel with resource needed and timeframe allocated. This achieves both traceability and due decision making process after evaluating and analyzing the aggregate data from the quality report.

Thank you

Philemon Pickson Ndhlovu

with the inception of zoom and other tele conferencing platforms, the options could be explored further.

However, the laboratory reserves the right to comply to 4.13 control of records of electronic in nature, access, indexing storage, ease of retrieval incase they may be needed for reference or tendered as evidence during audit.

Nyalieba Andrew Thok Gol

Thanks Alice for brining up a very serious point, am facing it very difficult with the government hospital that I support , The hospital management is not sporting the lab at all in the terms of QMS implementation, though we haven't Started the Management Review Meetings yet because we are still developing the QMS documents.

Janet Scholtz

To Nyalieba

My advice is to document the Hospital Management involvement into your process for MRM when you develop that.

I would also see if you can have a hospital management meeting every 3 months or even 6 months while you are implementing the QMS. Just focus on the items they need to assist with.

Philemon Pickson Ndhlovu

on suitability of procedures, the records needed are the updated master-list to see which documents are current and approved? or the review of specific/ departmental documents to ensure unintended use of obsolete documents?