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Developing QA/QC Documentation.

Developing QA/QC Documentation.

(OP)
As a senior project manager I am aware of the generalities of modern QA/QC practice. However until now I have always had experienced QA/QC personnel available... not only to do the physical inspections and audits, but also to prepare the initial processes and procedures. I am now in a position where I need to hire personnel to develop these documents from scratch. Anybody got any ideas where I can seek ideas to help me determine exactly what I want / need. Its a bit difficult to write a job description, when I even know what I want.

RE: Developing QA/QC Documentation.

QC supervisor position would require something like this

Responsible for all aspects of quality related to monitoring the process involved in manufacturing, including receiving, packaging, and shipping products manufactured at this facility.
Responsibilities of this job include:
• Inspect/test incoming components for compliance and collect samples for retention
• Complete and collect all necessary batch record documents for review
• Ensure proper cGMP compliance to ensure good product quality
• Ensure that all bulk components are available and released for packaging.
• Interface with QA, Operations, Production and Personnel Supervisors and Maintenance Mechanics with any quality issues and concerns
• Contribute to the ongoing effort of improving packaging quality and process improvement
• Oversee rework/resinspections


This of course implies to Quality Control position. Quality Assurance will be something like

Responsible for leading daily QC personnel, including but not limited to bulk materials, packaging components, finished goods evaluation/analysis and in-process batch adjustments.
Responsibilities of this job include:
• Interact with management, vendors, consultants and customers to assure quality and compliance
• Perform and participate in cGMP and/or regulatory quality audits
• Develop response and corrective action reports and monitor corrective actions
• Coordinate and review internal investigations performed on product and customer complaints
• Create, review, and modify all Master Manufacturing Records
• Approve changes requested for internal documentation
• Understand and enforce all GMP processes
• Understand and enforce all customer specifications and procedures

These can differ obviously based on demands and requirments. These were sort of ecamples- You can ask for more or less. In my opinion resumes can be hammed up a bit but during interview you can ask questions to make sure person is ready for the task he/ she is hired for.
Good Luck


RE: Developing QA/QC Documentation.

miningman,
Definitely more info required.
Are you the Owner / Client or are you the Contractor ?
I presume the industry is mining ?
If you are the Owner / Client your most important documents will be the various Project Specifications (which basically list all the things the Contractor has to comply with).
The complexity of these documents will be based on the industry - mining will be a lot less stringent than oil & gas for instance.
These are usually witten by Engineers - then the QA/QC personnels role is to enforce the requirements of these specifications.

If you are the Contractor then you have numerous procedures to be documented.
As an example:
Visual Inspection Procedure
Welding Procedure Specification Register
Welding Procedure Specifications
Welder Qualification Register
Welder Qualifications
NDT Procedures (RT, UT, MT, PT) - usually supplied by NDT subcontractor
Fabrication Procedures
Blasting & Painting Procedures - usually supplied by Painting / Blasting subcontractor
Dimensional Control Procedure
Material Control and Handling Procedure
Welding Consumable Control Procedure

This is just a basic list, different industries have different processes which will govern what is required.

The most important document from a QA/QC perspective for Owner / Client & Contractor is the ITP (Inspection & Test Plan).
A poorly written ITP can break a project - conversely a well written one can greatly assist in a successful project.
Written by the Contractor it is then submitted to the Owner / Client for review and it generally bounces backwards and forwards until all the issues are sorted out and agreed upon.
Obviously the Owner / Client want as much Inspection / Testing done for their quoted price as they can get.
Whereas the Contractor wants to do as little Inspection / Testing as possible for that same quoted price.
Finding a happy medium where both parties are satisfied goes a long way towards a harmonious project.
Good luck,
Cheers,
DD

RE: Developing QA/QC Documentation.

(OP)
Thanks guys , that helps. Yes I'm an owner, Y
  • es its mining but its more like heavy surface industrial construction. early work will be erection of a major shop repair facility. Any other suggestions gratefully received.

    RE: Developing QA/QC Documentation.

    Hire a QA consultant to advise you in your recruiting process? The guys that go around helping folks prepare for ISO 9000 certification etc.? Some of them supply drafts of the complete suite of generic process templates etc.

    However, then you are back to picking one that isn't just selling snake oil.

    Posting guidelines FAQ731-376: Eng-Tips.com Forum Policies http://eng-tips.com/market.cfm? (probably not aimed specifically at you)
    What is Engineering anyway: FAQ1088-1484: In layman terms, what is "engineering"?

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