Creating an Audit Schedule & Revamping QMS

Joeem

Involved In Discussions
#1
I've been given the responsibility to revamp our current quality system and also need to create a new audit schedule. We currently have about 30 Procedures, over 50 Work Instructions and over 100 forms, which in turn all need to be audited. I've heard from many people that I need to create more of a process oriented system, which could reduce the amount of controlled documents, but i'm afraid to get rid of things that might be important.

I'm very new at this, so any advice would help.
 
Elsmar Forum Sponsor
#2
Hello Joeem, and welcome to the Cove :bigwave:
I've been given the responsibility to revamp our current quality system and also need to create a new audit schedule. We currently have about 30 Procedures, over 50 Work Instructions and over 100 forms, which in turn all need to be audited. I've heard from many people that I need to create more of a process oriented system, which could reduce the amount of controlled documents, but i'm afraid to get rid of things that might be important.

I'm very new at this, so any advice would help.
Well... What can I say? I am anything but new at this, and I still reap great benefits from the hints and tips provided by the collective knowledge found here. :applause:

Anyway: Could you tell us a bit about how your QMS and audits are currently set up before we start? If your system becomes more process oriented, it should be reasonably easy to adapt the audit system to fit it.

If people have noted that you ought to move towards a more process oriented system I suppose you are getting feedback of some kind, but what kind of assistance can you expect from the rest of the organization? As for being afraid to get rid of things that may be important, it may not come to a need to get rid of anything but perhaps to present it in another way.

/Claes
 
#3
I've been given the responsibility to revamp our current quality system and also need to create a new audit schedule. We currently have about 30 Procedures, over 50 Work Instructions and over 100 forms, which in turn all need to be audited. I've heard from many people that I need to create more of a process oriented system, which could reduce the amount of controlled documents, but i'm afraid to get rid of things that might be important.

I'm very new at this, so any advice would help.
You don't say if your system complies with ISO 9001 or is registered. That would help us.
 
Last edited by a moderator:

Joeem

Involved In Discussions
#4
My system does comply with ISO 9001. We just had a ISO surveillance audit to be certified to ISO 9001 2008, which we have 4 CAR's to answer. 1 CAR is to complete the Current Audit Schedule by the end of June.
 

Joeem

Involved In Discussions
#5
Well, we have a procedure for each section of the AS9100. then More work instructions than what seems necessary. There could be up to at least 5 or 6 work instruction per procedure (section of the AS9100) which have the same 3 digit number that the procedure has with a different dash number(QP-4.13; WI-4.13-001), which tells you that that work instruction belongs or should be connected to that procedure. Although, if you look at most of the work instructions, they will lead you to somewhere else in the system, (to another section of the AS9100). To go with the Work Instructions, there are forms, which follow the same numbering scheme. In the work instructions and procedures, my quality manager started something which references any procedure, work instruction, or form that is mentioned or may have something to do with that document. If it is referenced in there, I would have to audit it.

THe Table of Contents shows all of these documents in a spreadsheet which shows the rev of the document, who owns it, whether its uncontrolled or not. The last person created the audit schedule from this, which basically only put an extra column in there with dates of when it was audited.

I hope that helps in describing how my QMS is run?
 
#6
My system does comply with ISO 9001. We just had a ISO surveillance audit to be certified to ISO 9001 2008, which we have 4 CAR's to answer. 1 CAR is to complete the Current Audit Schedule by the end of June.
Yes, you have a big challenge on your hands. However, you don't have to audit all these documents - you should be auditing process - and, in addition, sorting this all out doesn't need an audit to correct it.

Could you post the exact content of the ncs you were written? Completing the audit schedule seems a bit 'thin'...leave out any sensitive details but don't paraphrase. I'd also be concerned that your auditor hasn't brought this situation - not doing process audits - to your attention earlier.
 
M

misty1628

#7
I had the same job to do when I began working for my current company. There were about 20 procedures that were 3 to 7 pages long! Waste of time and paper. I got rid of all but 8 procedures. The only reason I have 8 is to satisfy TS requirements. Work instructions were out of hand as well. They are needed but I made sure they were going to be used before I would write them. There is no point to having a ton of procedures and work instructions if they are not used or value added. When I was wondering whether or not to write a procedure or work instruction, I asked myself "Who is going to USE it?", "Is it required by the standard?", "Is it helpful to the operator or operation of the company or QMS?".

I have been doing this for awhile and have several 3rd party audits with -0- non-conformances. I still look to this site for ideas though. There is always something new to learn or new ideas to consider.
 
#8
I had the same job to do when I began working for my current company. There were about 20 procedures that were 3 to 7 pages long! Waste of time and paper. I got rid of all but 8 procedures. The only reason I have 8 is to satisfy TS requirements. Work instructions were out of hand as well. They are needed but I made sure they were going to be used before I would write them. There is no point to having a ton of procedures and work instructions if they are not used or value added. When I was wondering whether or not to write a procedure or work instruction, I asked myself "Who is going to USE it?", "Is it required by the standard?", "Is it helpful to the operator or operation of the company or QMS?".

I have been doing this for awhile and have several 3rd party audits with -0- non-conformances. I still look to this site for ideas though. There is always something new to learn or new ideas to consider.
Welcome and thanks for sharing your experiences!

May I ask if your management team were any part of the decision to reduce the amount/content of documentation?
 
M

misty1628

#9
Some of it. When I re-wrote the procedures and other items I wanted to keep, I had management approve it. If they questioned me about obsoleting the enormous amount of procedures and instructions, I told them what I said on this site. What's the point of a procedure and/or instruction if it will not be used. Another point I should make too is that some of the forms I created for record purposes also serve as an instruction in some cases. Example is our inspection forms for the operators. It lists on the inspection form what gage to use and how often to check the part. The operators already know how to use the gages or were trained so there would be no need for "Gage Instructions".
 

Joeem

Involved In Discussions
#10
I don't want to sound stupid, since i'm new at this, but what does TS stand for? I work for an aerospace company, which needs to comply with ISO 9001:2008 & AS9100B. that's all i really know for sure. I know I need to try and slim our system down to a more process friendly system, but it's really hard with a q.m. who wants a quality procedure or work instruction for EVERYTHING. I'm so overwhelmed, since i have to do my first job along with this one, and I don't know how to fix the problem we are in now. ANY tips or advice would be helpful.
 
Thread starter Similar threads Forum Replies Date
V Creating an ISO 14001 Internal Audit schedule Internal Auditing 13
S Scheduling or Creating a Global Audit Schedule - Examples General Auditing Discussions 5
N Creating an Internal Audit Schedule Internal Auditing 48
Marc Creating an Internal Audit Program That Works for Your Organization Internal Auditing 0
B Creating an Audit Mechanism (System/Plan) General Auditing Discussions 3
N ISO 9001 based Audit Schedules: Creating and Maintaining - Template wanted General Auditing Discussions 5
M Problem creating a specification for "Final product audit" Customer and Company Specific Requirements 4
S Creating a Quality culture! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Y Creating Equipment qualification protocol Qualification and Validation (including 21 CFR Part 11) 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
L Hazardous Waste - Tips for creating standardized training Miscellaneous Environmental Standards and EMS Related Discussions 2
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
8 Creating Flow and Pull Game Lean in Manufacturing and Service Industries 6
B Main responsibility for Control Plans - creating and maintaining FMEA and Control Plans 15
shimonv Creating a new commercial product based on a modification to an existing product Other US Medical Device Regulations 4
R Creating WIs for a Heavy Civil Engineering Services company Document Control Systems, Procedures, Forms and Templates 19
M Creating a Plant Level Value Stream Map Process Maps, Process Mapping and Turtle Diagrams 1
T IMDS - Creating an MDS out of material and a made item? RoHS, REACH, ELV, IMDS and Restricted Substances 4
D How do I go about creating document logs and registers with the MS Excel Excel .xls Spreadsheet Templates and Tools 2
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Creating together Standard Definition for Prevention and Detection FMEA FMEA and Control Plans 1
M Creating change / Forcing change within a Company Lean in Manufacturing and Service Industries 7
A Creating a policy to evaluate the Third Party Security IEC 27001 - Information Security Management Systems (ISMS) 4
S Creating goals and objectives with targets and measurables for self-evaluations Management Review Meetings and related Processes 2
L Creating a xlsx Customer Complaint file to track Complaints Excel .xls Spreadsheet Templates and Tools 2
S When creating a 510k, which Guidance Document Wins? Other US Medical Device Regulations 9
P GS1 NHRN AIs - Creating Barcodes for Human Product Other ISO and International Standards and European Regulations 4
O Creating a Tool to Track & Verify Mistake Proofing Devices Document Control Systems, Procedures, Forms and Templates 5
B Any suggestion on creating the best paper plane that can hit a target perfectly? Coffee Break and Water Cooler Discussions 2
P Creating a PPAP document for my Suppliers APQP and PPAP 1
L Any recommendations on software for creating hierarchical workflows ? Misc. Quality Assurance and Business Systems Related Topics 2
AnaMariaVR2 Creating Global Giants from a Culture of Israeli Start-Ups Coffee Break and Water Cooler Discussions 0
R Creating a c-chart spreadsheet to use in my department Excel .xls Spreadsheet Templates and Tools 5
R Inspection Database Picker - Creating an Inspection Report Document Control Systems, Procedures, Forms and Templates 1
P Problem with creating VSM current map Lean in Manufacturing and Service Industries 3
G Creating an Organization Chart - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
C Creating a Multiple Table SQL (Structured Query Language) Query in Minitab Using Minitab Software 10
C Resources for creating Process Validation Procedures Qualification and Validation (including 21 CFR Part 11) 5
A Customer Profiles - Creating a Customer 'Profile' for our Top 10 Customers Document Control Systems, Procedures, Forms and Templates 2
M Creating an Index for our Documents - Imaging Millions of Paper Records Document Control Systems, Procedures, Forms and Templates 13
P Creating a Traceability Database with Microsoft Access Document Control Systems, Procedures, Forms and Templates 7
V Creating a Cosmetic Inspection Specification for Powder Coated Painted Finished Parts Manufacturing and Related Processes 7
I Difficulty in creating a Quality Manual Quality Management System (QMS) Manuals 4
L How can you capture many positions held without creating a lengthy resume Career and Occupation Discussions 4
Miner Intro to MSA of Continuous Data - Part 10: Creating gauge families Imported Legacy Blogs 10
E Manufacturing Planning - Creating Improvements Misc. Quality Assurance and Business Systems Related Topics 7
R Creating Quality System and using it before it is complete ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom