ISO 9K2K documentation (records) for small scale tool rooms or job shops

N

Net123

#1
My company is in the process of ISO 9000:2000 certification. We make assembly tooling, we will also put in controls (PLC’c, I/O’s Computers, software, logic etc) on automation equipment designed by other companies. Along with this we also service/repair/trouble shoot existing (older) machines in the market. The nature of our work is that of a job shop, we work on a ‘project’ basis. The core business-system of handling the projects varies greatly, (size of a project ~ $500 - $750K standard deviation being very large). When I look at it with the ISO 9K lenses it’s a very complex system, but in reality it isn’t there are only 30 employees who change many hats during the course of the day.

All the people involved in operations and the management (also the owners) are very committed to making quality products, (it just translates into survival for smaller corporations like us). The management is very supportive of my efforts and wants to implement the quality system hand in glove to their business system. I am however finding it increasingly challenging to develop a system of records that satisfy all the requirements of the standard and not translate into loads of paperwork and unnecessary documentation that we do not really use.

With this background I would really appreciate any one giving some ideas/tips or a sample quality manual that addresses small scale job shops or tool rooms.

Second part of the problem (which is a little more specific), I have trouble with the ‘service’ process. When our engineers go out and service some one else’s machines. There is no spec or definitive ‘process’ that they use every time, (each job is different and the ways in which service is carried out is dependant on number of factors: mostly common sense). I have a very loose service procedure and for now service personnel generate a service report which I use as a quality record (IMO, it hardly is); we had started customer satisfaction survey after every service, but stopped it after reports from our feild service guys that clients were getting irritated at large number of surveys. Any suggestions on how to handle service/repair of machines as a process that satisfies ISO 9K requirements in this type of setting?

:thanks: and sorry for the long post :bonk:
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
Welcome to the Cove! bigwave-d2.gif

There's nothing to apologize for in the length of your post. It's always best to describe the situation fully to get the most pinpointed responses.

Documentation is often a "sticking point" with small organizations. The first problem is they wrongly assume their system has to match some giant multinational. The entire point in ISO9001:2000 is to create an "appropriate" process which fits customer requirements and still remains usable and profitable for your organization.

I am however finding it increasingly challenging to develop a system of records that satisfy all the requirements of the standard and not translate into loads of paperwork and unnecessary documentation that we do not really use.

With this background I would really appreciate any one giving some ideas/tips or a sample quality manual that addresses small scale job shops or tool rooms.
In terms of "loads of paperwork" - what do you see as the requirement for just ONE CUSTOMER ORDER? Based on that, you can consider a customer-order based system which includes ONLY the information pertinent to that specific order. Often, the bulk of this paperwork is merely a copy (or the original) of what you supply to your customer with the order.

When we kept "hard copy" files for a similar operation, we had a fiberboard multi-section file folder with clasps to hold punched pages of documents. One section contained all correspondence from the customer, including the purchase order. Another section included technical details of the customer requirements. Another section contained correspondence and other information of dealing with OUR suppliers for this particular product. Another section contained internal information on scheduling of machines, personnel, tooling, for the product. Last section included Quality documentation and shipping and billing data. We also had one "Miscellaneous" section where we kept anything that didn't fit in the other sections.

If a customer had five products, each product had its own folder. Sometimes we had to duplicate purchase orders which ordered multiple products. We only shipped and billed product by product, regardless if 5 different products went to the same customer on the same day, there were 5 separate invoices. The upside of this is that customer cannot deny payment of the other four if only one shipment is in question.

Obviously, modern computer systems allow an organization to sort documents in any way it chooses and avoid creating hard copies as often as possible.

The essence of basing the sorting on a product-by-product basis is that you keep information sorted according to the way you actually deal with things in your shop - on a product-by-product basis. If you get a request for a similar product from a different customer, you can use the file for reference.

Similarly, when the second part of your situation arises:
Second part of the problem (which is a little more specific), I have trouble with the ‘service’ process. When our engineers go out and service some one else’s machines. There is no spec or definitive ‘process’ that they use every time, (each job is different and the ways in which service is carried out is dependant on number of factors: mostly common sense). I have a very loose service procedure and for now service personnel generate a service report which I use as a quality record (IMO, it hardly is); we had started customer satisfaction survey after every service, but stopped it after reports from our feild service guys that clients were getting irritated at large number of surveys. Any suggestions on how to handle service/repair of machines as a process that satisfies ISO 9K requirements in this type of setting?
the simple fact in your situation is that EVERY service call is different. However, there are certain "phases" to each service call which are the same, only the details differ:
often service organizations create forms and checklists with plenty of white space to add details (think about the checklist a service writer works with at an auto dealer's service bay - folks come in for everything from a routine oil change to massive accident damage, but the service writer manages to put everything on the same form.) If each service call is treated as a stand-alone event (which it is), then each deserves a separate file folder, just like a product folder.

offtopic-d2.gif It is important to note that most computer-based documentation systems are based on hard copy systems. The advantage to computer-based systems is the relative ease of storage and retrieval. The data entry can be easy or hard depending on personnel and availability of equipment. PDAs or notebook computers can help employees in the field, while judicious placement of terminals in production areas will allow personnel to retrieve data for reference as well as enter data based on activity.

Let's take up the topic of electronic document management in another thread, though. It's fascinating, but not necessarily the ONLY solution to your problem as stated.
 
Thread starter Similar threads Forum Replies Date
J Engineering having a hard time defining Objectives - ISO 9k2k 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Management Representative Requirements - ISO 9k2k Clause 5.5.2a interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
P Process Audit Worksheets for ISO 9k2k - Marketing Analysis Process Audits and Layered Process Audits 2
W Re: Training for ISO 9K2K General Auditing Discussions 15
D Is ISO 9001:2000 (9k2k) HARDER than the 1994 Version? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G ISO 9k2k 8.2.3 General Auditing Discussions 21
R QS Shop upgrading to ISO 9K2K QS-9000 - American Automotive Manufacturers Standard 1
K TS 16949 & ISO 9K2K BENEFITS QS-9000 - American Automotive Manufacturers Standard 1
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3

Similar threads

Top Bottom