Help with understanding Process Controls

#1
We have an upcoming audit and I've been asked to respond to the following question:

Are process controls properly implemented(e.g. capability studies performed, proper sample sizes and frequency, control limits recalculated, etc)?

I am unsure what ISO requirement this relates to(I'm familiar with ISO 9001 requirements) and I'm not familiar with most of the terminology here so hoping someone can help me to better understand how this applies to our business so I can respond.

A bit of background first(this may answer the question), we manufacture electronic devices. Our contract manufacture solders all the components and performs 100% inspection via AOI and 3D X-Ray. Upon receipt we do an incoming inspection using AQL level 2, this is the only time we do any sampling. All programming is followed by a final test(verify all features are working and correct software is installed) which is performed on 100% of product prior to shipment(if the product fails final test the product can not ship - our ERP system won't let us as we log only passing serial numbers and only print a serial number for products that pass), then a final inspection by a 2nd person takes place where again 100% of products are inspected prior to pack and shipment.
 
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John Predmore

Trusted Information Resource
#2
Welcome to Elsmar.

The first section of ISO 9001 you should look over is 8.5.1 Control of Production and Service Provision.

Your company must have determined what are the appropriate criteria to focus on and the appropriate way to measure and control those. The auditor will assess the effectiveness of those controls by looking at production records and customer feedback.

You did not say who is asking you about proper implementation. Once your company decides to do capability studies, inspection sampling and control charts, yes, it is important that those planning and control activities be implemented correctly. You probably need to ask a more specific question for somebody here to have enough information to give you a specific response. If you want to know generally what these terms mean and how they are used, may I suggest the search function on this website.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
What standard are you trying to satisfy? You say you are familiar with 9001, is there a different standard you are unsure about?
 
#4
The question asked you was a little vague. I assume that you need to satisfy the requirements of ISO 9001:2015, then the process control is to ensure that the organization determines the processes needed for its quality management system in accordance with ISO 9001: The following requirements should be considered:
——you should determine the inputs required and the outputs expected from its process;
——when determining the sequence and interaction of these processes, the links with the inputs and outputs of the previous and subsequent processes should be considered;
——to make sure that process is effective, the process control criteria and methods should be determined and applied by you;
——you should determine the resources needed for processes, such as people, infrastructure, environment for the operation of the processes;
——you should assign the responsibilities and authorities for its processes by first determining the activities of the process and then determining the persons who will perform the activities;
——you should ensure that any actions needed to address risks and opportunities associated with the processes are implemented;
——you should consider the performance date obtained through the review of criteria established for monitoring and measuring; analyze and evaluate this data, and implementing any changes needed to ensure that these processes consistently achieve their intended result;
——you can use the results of analysis and evaluation to determine the necessary actions for improvement; improvements can be made at the process level or at the quality management system level.
 

optomist1

A Sea of Statistics
Super Moderator
#5
Hi Newbie Quality,

"Are process controls properly implemented(e.g. capability studies performed, proper sample sizes and frequency, control limits recalculated, etc)?"

A bit of an understatement here but the above sentence is so important and broad in required content, if not immediately, soon I would seek out APQP, MSA, SPC, etc., training. This training is inavaluable...and in many cases one subject provides the foundation for others, and the benefits are near and long-term. As per the above Elmar posters, some of this needs to be bounded by the field you and your firm are in...hope this helps
 
#6
Welcome to Elsmar.

The first section of ISO 9001 you should look over is 8.5.1 Control of Production and Service Provision.

Your company must have determined what are the appropriate criteria to focus on and the appropriate way to measure and control those. The auditor will assess the effectiveness of those controls by looking at production records and customer feedback.

You did not say who is asking you about proper implementation. Once your company decides to do capability studies, inspection sampling and control charts, yes, it is important that those planning and control activities be implemented correctly. You probably need to ask a more specific question for somebody here to have enough information to give you a specific response. If you want to know generally what these terms mean and how they are used, may I suggest the search function on this website.
heard hard
 
#7
We have an upcoming audit and I've been asked to respond to the following question:

Are process controls properly implemented(e.g. capability studies performed, proper sample sizes and frequency, control limits recalculated, etc)?
What type of audit is this? I'm wondering who would be asking a question which looks like a requirement turned into a question. I don't think this question is based on ISO 9001
 

John Broomfield

Staff member
Super Moderator
#8
Look for evidence of effective:

A. Planning and preparation so every member of the process team knows what is required.
B. Monitoring and provision of competent people and capable equipment.
C. Mistake proofing so activities cannot be done the wrong way.

Evaluate the evidence and ask what often goes wrong; compare with what you hear and see. Follow up on what doesn’t sound right or looks odd.
 
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