Definition of Action Item - Action Items In Management Review

M

michael riley

#1
:) Hey everyone,
The external auditors tell us that we have to track our action items as evidence of continouous improvement and management review.These action items must be dated and show completeion in a timely manner.What is happening is that everyone is calling everything an action item. I fear that after a month or two focus will be lost and action items will not be updated and there will be 100 action items open when the external auditors come in.
My definition of an action item in reference to TS 16949 and management review is : :an issue that is systemic to the Quality System (such as records not being kept or not having a proper training process) or an issue that could affect customer requirements such as delivery compliance.
I do not believe that action items are day to day issues such as units having mechanical problems or production flow is disrupted due to a issue at a unit up stream. Day to day operational issues are just that day to day normal things. I feel we have to be careful of what we call action items.
So my question(s) are What is the definition of an Action Item and has anyone else has this problem.
Thanks Mike:thanx:
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
The action item will be, for each item's person assigned to it, from an area within normal control. That means production for the production manager, etc.

Items should be based on mission, policies and objectives. They should be developed by reviewing and considering, among other things, internal and external audit reports, appeals and complaints, continuous improvement requests, and matters arising from peer evaluation processes etc..

Spreadsheets can be used to track the items, owners, schedules and milestones; and to thus indicate attention and progress. Minutes from management review meetings can show the more detailed progress.

In the early process of defining action items it may help to chart the various problems and try to establish if there are relationships between them. Management members may then discover some of their action items can be combined as steps in a larger project.

All in all management needs to learn to ask the 5-whys to boil down causes of the problems so action items aren't symptoms, but the actual problems.

Does this make sense?
 

RoxaneB

Super Moderator
Super Moderator
#3
riley said:
The external auditors tell us that we have to track our action items as evidence of continouous improvement and management review.These action items must be dated and show completeion in a timely manner.
Not only does it demonstrate Continual Improvement and that Management Review is being done, but it demonstrates Management Commitment. It shows that there is an interaction at the Review and it's not just one person talking. It shows that there is a conscious decision - and hopefully willingness - to adjust, revise and improve the system.

riley said:
What is happening is that everyone is calling everything an action item. I fear that after a month or two focus will be lost and action items will not be updated and there will be 100 action items open when the external auditors come in.
Define "everything", please.

If there are 100 action items to be done, my concern is that there are ongoing and systematic lapses in your system...that people may not be fulfilling their responsibilities. If there are 100 action items, that should be a trigger for an agenda topic at your next Management Review to discuss why there are so many items.

riley said:
My definition of an action item in reference to TS 16949 and management review is : :an issue that is systemic to the Quality System (such as records not being kept or not having a proper training process) or an issue that could affect customer requirements such as delivery compliance.
I do not believe that action items are day to day issues such as units having mechanical problems or production flow is disrupted due to a issue at a unit up stream. Day to day operational issues are just that day to day normal things. I feel we have to be careful of what we call action items.
So my question(s) are What is the definition of an Action Item and has anyone else has this problem.
I agree that the day-to-day issues do not need to be action items generated from your Management Review, but things like results from Internal Audits not being addressed, Opportunities for Improvement that have been generated, and so on are areas where action items can be generated. As are aspects that are key to your Business System and company philosophies that are monitored and actions that need to be taken (everything from updating monthly results to addressing an outside-of-the-control-limits result).

Basically, use the agenda and Management Review requirements as the sources for your action items.
 

Sambasi

Involved - Posts
#4
The discussions in Management Review Meeting are based on the agenda and action points coming out during discussions are somewhat broad. The responsible persons have to work out their own action plan individualy to complete them.These are not day to day kind of issues(unless a kind of fire fighting in the same area often which affects operations or system maintenance) but aim at improvements.

The format for recording "Minutes of management review meeting" may include columns for (i)S.No. (ii)Points Discussed/Action Points (iii)Responsible (iv)Target Date(v)Date of completion(vi)Remarks . The MR,whille reviewing the minutes(monthly or quarterly) may update the date of completion and record the reasons, if any for deley, against each action points.
 
Last edited:

Helmut Jilling

Auditor / Consultant
#5
riley said:
...What is happening is that everyone is calling everything an action item. I fear that after a month or two focus will be lost and action items will not be updated and there will be 100 action items open when the external auditors come in....

So my question(s) are What is the definition of an Action Item and has anyone else has this problem.
Thanks Mike

As in everything, a little balance may be called for. It is useful to consider why this requirement is in the standard. Then, it provides guidance as to how to proceed. It might be useful to consider these action items to be more like Continual Improvement projects. Little items should just be done. It is not worth the time and effort to track everything.

For example, a reminder that the coffee supplies are low and need to be reordered certainly does not need to be tracked as an action item.
 
#6
Vital few, trivial many..........

riley said:
:) Hey everyone,
The external auditors tell us that we have to track our action items as evidence of continouous improvement and management review.These action items must be dated and show completeion in a timely manner.What is happening is that everyone is calling everything an action item. I fear that after a month or two focus will be lost and action items will not be updated and there will be 100 action items open when the external auditors come in.
My definition of an action item in reference to TS 16949 and management review is : :an issue that is systemic to the Quality System (such as records not being kept or not having a proper training process) or an issue that could affect customer requirements such as delivery compliance.
I do not believe that action items are day to day issues such as units having mechanical problems or production flow is disrupted due to a issue at a unit up stream. Day to day operational issues are just that day to day normal things. I feel we have to be careful of what we call action items.
So my question(s) are What is the definition of an Action Item and has anyone else has this problem.
Thanks Mike:thanx:
Is exactly the way to go, Mike!

As with most things in life, there should be some priority to doing things. A principle idea from an effective management review is to identify and then make assignments for a few items which need correction or improvement. That way you won't overwhelm the whole system and it's people with 'busy work' Just as you said.....

I know, you just needed validation!:agree1:

Andy
 

Wes Bucey

Quite Involved in Discussions
#7
From my point of view:
Management Review (in terms of ISO conformance) is typically the review of an internal audit, so it probably would not have items like low coffee supplies or lightbulb replacement on the agenda (which typically have someone assigned to do those things on a regular basis) UNLESS the function of replacing lightbulbs was not being accomplished. If the lightbulbs aren't being replaced, the ACTION ITEM would be to "train" or "remind" someone to perform the function. (Think of this as the difference between a "corrective action" and a "correction" where a correction on a machine might be to replace a broken tool bit and the corrective action would be to add a step to the process to check for broken tool bits on a regular basis.)

During the Management Review, managers look at each item on the agenda and decide one of the following:
  1. Leave as is, no action required
  2. Determine Corrective Action to fix a nonconformance, assign someone to be responsible and grant authority to perform the task and set a review date to determine if the nonconformance is permanently eliminated by the Corrective Action.
  3. Set up a study to determine if a process currently conforming can be improved or made more efficient, assign one or more folks with responsibility and authority to conduct the study and try experiments and a target date to report
 

Jim Wynne

Staff member
Admin
#8
Wes Bucey said:
During the Management Review, managers look at each item on the agenda and decide one of the following:
  1. Leave as is, no action required
  2. Determine Corrective Action to fix a nonconformance, assign someone to be responsible and grant authority to perform the task and set a review date to determine if the nonconformance is permanently eliminated by the Corrective Action.
  3. Set up a study to determine if a process currently conforming can be improved or made more efficient, assign one or more folks with responsibility and authority to conduct the study and try experiments and a target date to report
You provide a good generic example of a management review process; it's the way that most, I think, would agree that things should happen.

I have to wonder, though, if something important isn't being missed. Why should people have to wait for a management review meeting in order to get permission to fix a problem? I think the whole Deming 85/15 thing needs to be rethought; many problems don't get solved at the point of attack because the people best qualified to fix them can't get permission to do it.
 

Helmut Jilling

Auditor / Consultant
#9
Wes Bucey said:
From my point of view:
Management Review (in terms of ISO conformance) is typically the review of an internal audit, so it probably would not have items like low coffee supplies or lightbulb replacement on the agenda (which typically have someone assigned to do those things on a regular basis) UNLESS the function of replacing lightbulbs was not being accomplished. If the lightbulbs aren't being replaced, the ACTION ITEM would be to "train" or "remind" someone to perform the function. (Think of this as the difference between a "corrective action" and a "correction" where a correction on a machine might be to replace a broken tool bit and the corrective action would be to add a step to the process to check for broken tool bits on a regular basis.)

During the Management Review, managers look at each item on the agenda and decide one of the following:
  1. Leave as is, no action required
  2. Determine Corrective Action to fix a nonconformance, assign someone to be responsible and grant authority to perform the task and set a review date to determine if the nonconformance is permanently eliminated by the Corrective Action.
  3. Set up a study to determine if a process currently conforming can be improved or made more efficient, assign one or more folks with responsibility and authority to conduct the study and try experiments and a target date to report

Actually, all the companies I am familiar with do much more in management review, than to review the audits. The list of ISO 9001 agenda inputs is much broader as well. Most of my clients use it as a business review of the system and their performance levels. They review all their metrics, etc.

The rest of your comments I agree with.

I also agree with Jim's comment, that audit results should not wait until a management review for consideration. Most of my clients review audits right after they take place, with the affected departments. At the management review, they review audit results as they pertain to the processes being reviewed.
 
#10
Well yes, but........

hjilling said:
Actually, all the companies I am familiar with do much more in management review, than to review the audits. The list of ISO 9001 agenda inputs is much broader as well. Most of my clients use it as a business review of the system and their performance levels. They review all their metrics, etc.

The rest of your comments I agree with.

I also agree with Jim's comment, that audit results should not wait until a management review for consideration. Most of my clients review audits right after they take place, with the affected departments. At the management review, they review audit results as they pertain to the processes being reviewed.
The results of audits isn't simply the details of the non-conformities found and, surely, they should be addressed at the time of the audit.

I've seen many management reviews where folks are forced to sit a listen to the audit manager/MR reviewing individual 'findings' of the audits, done since the last management review..............wow, no wonder no-one wants audits or to attend the meeting!:yes:

In these cases, something's missing from the 'results of audits' that management can understand. So, my recommendation is to treat this report out as an analysis of trends from the audits and what requirements are affected (by conclusion). So, if the metrics of product and process show overall good performance, then the 'results of audits' should confirm to management that the documented qms is being followed, and that the metrics can be 'trusted'. If not, the audits will have revealed what needs to be fixed.........

Any other kinds of report out on audits is just dull!:rolleyes:

Andy
 
Last edited:
Thread starter Similar threads Forum Replies Date
K Definition Correction, Corrective Action and Preventive Action - Definition of terms Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 28
M Definition Immediate Corrective Action - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 11
Hershal Definition Preventive Action - Definition - How does YOUR organization define PA? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
C Definition CAR - Corrective Action Request - What is the Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Definition Containment Definition - The first action taken when a nonconformance is identified Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
R Preventive Action (PA) Examples - Seeking Examples, not Definition Nonconformance and Corrective Action 11
M Definition Aviation - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
S Importer definition EU Medical Device Regulations 0
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
J Definition Defect Mapping - Here is my definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
F MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
S Definition of "servicing activities" - Spinal Implants ISO 13485:2016 - Medical Device Quality Management Systems 4
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
C Function definition for DFMEA FMEA and Control Plans 1
W Key functional characteristic definition - Tolerances and Deviations Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Waiver - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
M Informational MHRA guidance – Assistive technology: definition and safe use Medical Device and FDA Regulations and Standards News 0
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 15
Pancho Definition Quality Assurance Program - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 14
G Medical Device "Immediate Container" Interpretation of Definition US Food and Drug Administration (FDA) 2
S Definition of Convenience Kit for a Combination Product US Food and Drug Administration (FDA) 0
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Definition of "Sensitive Products" Clause 8.5.4 (c) in AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Marc Definition Jidoka - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Marc Definition DFMEA (Design FMEA) - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
J Definition of repackager v. manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
C Informational CFR 21 Definition for Data or Raw Data Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5

Similar threads

Top Bottom