Roles and Responsibilities - Quality Manager, Lab Manager and Technical Manager ?

[Ajit Basrur]

Within a laboratory, how would you define the roles and responsibilities for a

1. Quality Manager

2. Laboratory Manager, and

3. Technical Manager

What is the practise for small laboratories - is there a single person fulfilling all these 3 roles ?

[Phiobi]

At my company we have a small lab within our core business of manufacturing.

The technical manager is responsible for the implemenation of procedures

The lab manager is responsible for the day to day running of the lab and writing procedures

The Quality Manager (Me) is responsible for ensuring, through pier review, that all documentation, systems, equipment and people comply to the relevant regulations (ISO/AS/NADCAP)

Although the quality manager may not have the technical skills required to over see the whoel system they do tend to have an eye for mistakes and the ability to ask 'stupid' questions that lead to serious answers

[SteveK]

All I would say – is it depends. As picked up in other threads, should ideally separate out e.g. QA from QC from Technical etc, but in the dim and distant past I was a Technical Manager, who happened to run a lab (mainly physical testing) and had a regulatory (QA) function (e.g. writing/controlling Technical Files – as well as writing SMs, SOPs, Specifications etc for transfer into QC). We were a small device orientated setup in a much larger pharma function. Sometimes you have to wear many hats.

[Ajit Basrur]

In Reply to Parent Post by SteveK

All I would say – is it depends. As picked up in other threads, should ideally separate out e.g. QA from QC from Technical etc, but in the dim and distant past I was a Technical Manager, who happened to run a lab (mainly physical testing) and had a regulatory (QA) function (e.g. writing/controlling Technical Files – as well as writing SMs, SOPs, Specifications etc for transfer into QC). We were a small device orientated setup in a much larger pharma function. Sometimes you have to wear many hats.

Actually I do - during last audit, the auditor asked me who are these 3 persons and to that I replied that I am

[David Liew]

Ajit,

Seem like you are one person running the lab. How you configure to check your own work effectively?

[Hershal]

In Reply to Parent Post by Ajit Basrur

Within a laboratory, how would you define the roles and responsibilities for a

1. Quality Manager

2. Laboratory Manager, and

3. Technical Manager

What is the practise for small laboratories - is there a single person fulfilling all these 3 roles ?

Your challenge is not even close to being unique. I see this all the time in small labs and single-person labs. If you are dealing with ISO/IEC 17025:2005 the roles of the technical and quality managers with respect to the quality and technical operations is somewhat defined, and some things specifically directed.

The biggest thing in those instances is that you are CLEAR when you are wearing the technical or quality hat. Single person labs have the biggest challenge obviously in this regard, but it can be managed.