Evidence of Continual Improvement

C

C Emmons

#1
During the last couple of audits our auditor has pushed for evidence of continual improvement suggesting that he would like to see some kind of log with ongoing progress notes, dates etc. The problem I have is trying to control 20 different managers at 20 different facilities into keeping the logs/notes. Just does not happen. I am looking for suggestions and or input as far as how other companies are handling this?
 
Elsmar Forum Sponsor
#2
Quality Objectives

This is in the ISO9001:2000 forum so you must have Quality Objectives. (At the risk of sounding like Jim Wade, you should have Quality Objectives whether you are ISO or not). Read 8.5.1. Present your positive trends for the measurables in your Quality Objectives to show you are observant of your Quality Policy. Show your audit results (Findings, corrective action, finding of acceptable corrective action). You must have a documented procedure for CA/PA. Show your actions that support 8.5.2 a-f and 8.5.3 a-e. Finally, show your management review I/O (evidence of 5.6.2 and 5.6.3). Hopefully, there are objectives, responsibilities and due dates set here. If you are meeting the intent of the sections listed above the answers to your auditors questions are in the standard. Show them the standard and how you meet it. Do not create yet another paperwork system to show an auditor and depress your 20 managers. (Now I really sound like JW!).
 
#3
I would suggest some type of simple database (we use Access) that could be used by all the different managers to record their CI activities. This would standardize the reporting and help facilitate the sharing of best practices.
 
G

Groo3

#4
I can't say that our system is anything like yours, but hopefully this will help by showing you another perspective. Only our Site and one manufacturing building down the road are covered under our registration. We use a "canned" software package (IBS / QSI System 9000A / System 14000 Integrated) at my facility which helps us with compliance to the ISO-9001 / 16949 / 14000 requirements (though we are not yet registered to 16949 nor 14000), and helps us centralize, manage and control a lot of information in a few locations.

To document continuous improvements, we review the efforts of all our Departments at our Management Review meetings. Improvement efforts as well as measures against our goals and objectives, and any resulting Actions... these efforts are recorded in our Management Review database (MR meeting minutes and Actions).

Other continuous improvement efforts are recorded in our Change Management and Preventive Actions databases.

As for suggestions? with 20 managers at 20 locations, you may want to have a central system that each of those 20 managers can enter their notes in... Either make it easier for these individuals to provide you with information, or find the information elsewhere? Are they not providing you with information because they don't understand why you need to have it? If so, further explaination / training may help to get that information flowing? Periodically, we provide our Leadership Team with a full day or two of training on the ISO-9000 Standards. We typically see more cooperation as a result of that training.

One last thing which may ensure they would update their logs / notes would depend on who the boss is? :frust: have you / can you make it part of their jobs to provide you with that information? are their raises / reviews conditional on how well they communicated their logs / notes? When faced with that brick wall - if all else fails, I either go above the wall or around it...
 

howste

Thaumaturge
Super Moderator
#5
8.5.1 only specifies what "tools" should be used for continual improvement. There is no requirement to have logs of notes showing activities and such (other than records of corrective & preventive actions). To me, evidence of continual improvement is not shown by tracking use of the tools, but by the results.

If it's been done right, top management has determined objectives that are key to the success of the business. The best evidence of continual improvement is a trend in the right direction for the objectives showing that the business is improving.
 

Wes Bucey

Quite Involved in Discussions
#6
C Emmons said:
During the last couple of audits our auditor has pushed for evidence of continual improvement suggesting that he would like to see some kind of log with ongoing progress notes, dates etc. The problem I have is trying to control 20 different managers at 20 different facilities into keeping the logs/notes. Just does not happen. I am looking for suggestions and or input as far as how other companies are handling this?
I'm not quite sure what you define as "continual improvement" in your organization. Here's what my Quality Manual says on the subject:
8.5.1 Continual improvement

We have documented procedures to define the activities involved in improvement of any process including corrective and preventive actions which apply to actual or potential nonconformance.

We implement elimination of causes to the degree appropriate to the magnitude of problems and proportionate with the risks encountered.
(This simply means we sometimes make a value judgement whether the scope of the project is small enough to make it cost effective to simply screen out non-conforming parts rather than invest a large capital amount in equipment or facilities to cure the root problem.)


We maintain records of these activities and notify customers as required.


Are we talking apples and apples or apples and oranges? Perhaps if you have a clear definition of what your organization terms continual improvement activities, the logs might not be so voluminous or burdensome for staff to maintain. If you don't keep a record of the activity, how do you evaluate what worked or didn't work in the past?
 
#7
howste said:
8.5.1 only specifies what "tools" should be used for continual improvement. There is no requirement to have logs of notes showing activities and such (other than records of corrective & preventive actions). To me, evidence of continual improvement is not shown by tracking use of the tools, but by the results.

If it's been done right, top management has determined objectives that are key to the success of the business. The best evidence of continual improvement is a trend in the right direction for the objectives showing that the business is improving.
My point exactly (only better stated). Don't create a new process (a logbook) to prove this to an auditor. The positive RESULTS and TRENDS are your best evidence of continal improvement. You should have them already!
 
M

M Greenaway

#9
Our external auditor merely asked to name a couple of improvment intitiatives that had been done over the past year !

Could have been anything, from re-carpeting reception to buying a piece of plant.

I find a lot of people see these requirements of ISO9001 in isolation to each other. For example they set objectives, they measure process performance but not against objectives, they then quote examples of continuous improvement not related to process measures or quality objectives - is it me or is this bleedin daft !!
 
Thread starter Similar threads Forum Replies Date
Q Process Approach & Continual Improvement Clauses and Evidence of its Effective Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Anerol C What can I show as evidence of Continual (Continuous) Improvement? Preventive Action and Continuous Improvement 81
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Informational Critical Thinking and the Process of Evidence-Based Practice Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
qualprod Evidence of a talk or phone call in approvals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Clinical evidence for Class II medical devices in EU and US EU Medical Device Regulations 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
R Timeframe for IATF 16949 certification to accumulate evidence of conformance of systems? IATF 16949 - Automotive Quality Systems Standard 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
E ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 8.1.3 Management of change - Evidence of HIRA and related things Occupational Health & Safety Management Standards 3
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
mikinnear Evidence - Class IIb Disinfectant Sanitiser EU Medical Device Regulations 2
G FAI Objective Evidence AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Interested parties requirements - Evidence of control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J MDR and Creative Clinical Evidence Other ISO and International Standards and European Regulations 2
B IATF 16949 Cl. 9.2.2.1 - Internal audit program - Types of evidence Internal Auditing 1
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF 16949 Cl. 7.1.6 - Organizational Knowledge - What evidence to have? IATF 16949 - Automotive Quality Systems Standard 1
D No evidence of certain processes on our scope being audited at our remote location IATF 16949 - Automotive Quality Systems Standard 4
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
R What kind of Objective Evidence - AS9100 Cl. 7.1.6 - Organizational Knowledge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
O ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Type of evidence for Mandatory procedures 4.4.2 A ad 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
L AIs the R&R study a training evidence considered ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Audit Ethics and Practices regarding Evidence Internal Auditing 18
S Evidence of Competence, Training and Awareness Training - Internal, External, Online and Distance Learning 5
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Chennaiite Audit Objective Evidence - the holy **** Imported Legacy Blogs 1
J Evidence of ISO Training for all Employees Training - Internal, External, Online and Distance Learning 27
K Evidence for Language Knowledge of Employees Professional Certifications and Degrees 9
S What would be the evidence for trained/competent inspectors? Quality Manager and Management Related Issues 4
Q Closing Out a Corrective Action - Strictly what is an Evidence? Nonconformance and Corrective Action 8
T Safety and Effectiveness of Medical Device - What evidence needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Clause 7.4.1.2 - Evidence of annual assessments for all non-TS Suppliers IATF 16949 - Automotive Quality Systems Standard 16
W Inspection Records Content and Acceptance Evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom