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.
 
Elsmar Forum Sponsor

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?
 

lanley liao

Involved In Discussions
#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.
 
Thread starter Similar threads Forum Replies Date
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
michellemmm Need help in understanding "Equipment performance in any attitude!! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
G Help in understanding my Gage R&R results on a pH meter Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
K Verification of Purchased Product - Help Understanding Clause 7.4.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Need help understanding Ford's Phase 0 PPAP APQP and PPAP 1
B Help understanding the ISO/TS 16949 Clauses IATF 16949 - Automotive Quality Systems Standard 3
E Contract manufacturer seeking help understanding ISO 13485 Validation requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 8
A Nonconformity help IATF 16949 - Automotive Quality Systems Standard 5
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
A Help needed with locating conector Design and Development of Products and Processes 0
Y CER: can "state of the art" help to make up for literature search on equivalant devices? EU Medical Device Regulations 1
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
B Can someone help me explain P-Value with a simple word please? Capability, Accuracy and Stability - Processes, Machines, etc. 11
M Help on formulating a LP minimization problem Manufacturing and Related Processes 2
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
M Thanks for the help Coffee Break and Water Cooler Discussions 0
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Burn out - Tips to help combat QC burnout Career and Occupation Discussions 19
Emran.mi Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2

Similar threads

Top Bottom