Identifying Processes thru Work Instructions

O

old and gray

#1
Processes

I have read many, many theads on processes. My question before I do alot of unnecessary work is " our system was built on work instructions for the people performing their jobs." These work instructions describe what is being done by those people performing ther jobs. For example, our purchasing department orders material based on the product and availability of the product. Their work instructions say the must order from an approved supplier base, have the supplier appproved, and accept product bases on quality and delivery.

These work instructions are for all people who are involved in processing our products.

My question is, are these work instructions that we have for all people performing their jobs good enough to satisfy the ISO standard for identifying our processes?
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
Re: Processes

Originally posted by old and gray
My question is, are these work instructions that we have for all people performing their jobs good enough to satisfy the ISO standard for identifying our processes?
I would definitely say no. From ISO 9001:2000 4.1:

The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
From ISO 9001:2000 4.2.2:

The organization shall establish and maintain a quality manual that includes... a description of the interaction between the processes of the quality management system.
A list of work instructions would certainly not meet these requirements. The work instructions are methods of controlling the actual processes.
 
N

noboxwine

#3
Welcome Aboard Old & Gray

I agree with howste. Sounds like you may have pieces of it, but needs some more work. Take a look at the myriad of models that are probably available in the Cove ( I am link and attachment challenged so you're on your own). I can send you one of my own on a PM if you'd like. Have a day
 
Last edited by a moderator:

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Sorry, old and gray, I gotta agree with the others. You could, if you wanted, show sequence, interaction, and measures via text, (most use flowchart-type charts for at least part of the job) but I don't think work instructions would do this adequately on their own. As nobox said, there are several different examples here on the Cove to give you ideas as we went thru this question in great detail not long ago. Depending on your registrar, this might not have to be too detailed and complex. Some elect to do great and very complex diagrams while others have gotten along with much simpler diagrams. Create something that meets YOUR needs first, then tweek if required to get the registrar's blessing. JMO.
 
Thread starter Similar threads Forum Replies Date
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Y Identifying measurable processes: How not to lose the forest behind the trees? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Process Auditing - Identifying/Monitoring "Key" Processes Sufficient? Process Audits and Layered Process Audits 5
R Identifying Outsourced Processes - Training, Calibration, Consulting - TS-16949 IATF 16949 - Automotive Quality Systems Standard 2
D Identifying Business System Processes IATF 16949 - Automotive Quality Systems Standard 2
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
T "Indication for Use" Identifying Specific Procedures US Food and Drug Administration (FDA) 2
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Audit NC - Not identifying our Customer Specific Requirements - TS16949 (7.3.6.3) General Auditing Discussions 7
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
V Identifying Significant Factors - Regression Analysis vs Correlation vs ANOVA vs DOE Quality Tools, Improvement and Analysis 7
F Requesting Help in Identifying Ford Suppliers Supplier Quality Assurance and other Supplier Issues 6
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
A Identifying the Clean Room Requirements for a Medical Device in US and EU ISO 13485:2016 - Medical Device Quality Management Systems 3
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
F Identifying Calibration on Small Tools (Measurement Equipment) General Measurement Device and Calibration Topics 2
C Identifying Response Times for CAPAs (Corrective and Preventive Actions) Nonconformance and Corrective Action 2
J Need help identifying nonconformities in internal audits Internal Auditing 2
A Identifying trends in QMS Nonconformities Quality Manager and Management Related Issues 1

Similar threads

Top Bottom