Auditing Incoming Materials (Store) - No Procedures nor Inspection carried out.

J

joebrown

#1
Hi it's Joe Brown again. I would like to thank all who gave a reply to my first question. The input was very usefull.

I have another one.

I am in the process of carrying out an audit on our incoming materials Dept. (stores) The company I work for do not have any written instructions and they do not inspect any product, the components go straight into storage and when required are issued to the shop floor.

How do I audit a process when there is no work instruction or procedures and they do not carry out any incoming inspection.


:thanx:
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Stores - incoming materials

Hi it's Joe Brown again. I would like to thank all who gave a reply to my first question. The input was very usefull.

I have another one.

I am in the process of carrying out an audit on our incoming materials Dept. (stores) The company I work for do not have any written instructions and they do not inspect any product, the components go straight into storage and when required are issued to the shop floor.

How do I audit a process when there is no work instruction or procedures and they do not carry out any incoming inspection.
Sounds like the audit is complete, and the finding is that there there are no documented requirements. :D

It's not clear if this is an ISO 9001 question, or if some other (or no) standard is involved. You say your company has no written instructions--does this apply just to your stores situation, or the company in general?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Stores - incoming materials

Thread moved from the 'Elsmar Forum Policies' forum.
 
J

joebrown

#5
Re: Stores - incoming materials

Sounds like the audit is complete, and the finding is that there there are no documented requirements. :D

It's not clear if this is an ISO 9001 question, or if some other (or no) standard is involved. You say your company has no written instructions--does this apply just to your stores situation, or the company in general?
My company is approved to ISO 9001 :2000. They have very little written instructions in place. Apart from the 6 required in the ISO standard.
Just need some guidance on how to conduct an audit.
:thanx:
 
J

joshua_sx1

#6
Re: Stores - Incoming Materials

…perform the combination of document & process audit…

…and as long as those “very little” written instructions that your company has are sufficient, suitable and effective to your operations… I don’t see any reason why you need to have bulky written instructions… in fact, if your “little” written instruction is already enough and effective (as your company is already an ISO 9001:2000 certified), it is the most ideal one…
 

Jim Wynne

Staff member
Admin
#7
Re: Stores - incoming materials

My company is approved to ISO 9001 :2000. They have very little written instructions in place. Apart from the 6 required in the ISO standard.
Just need some guidance on how to conduct an audit.
:thanx:
Have a look at the link in Sidney's post, if you haven't already. In the absence of documentation, you still have to determine what the requirements are, and the way to do that is by talking to management about what's expected. From the document Sid links to:
The auditor should request information on the auditee's operating processes and subsequently ask questions, record answers and observe staff at all levels (including administrative personnel, process owners and operators), to confirm that the actual working status conforms to the descriptions given.

Thereafter, the necessity for any documentation should be evaluated in the light of the observed need for consistency, and the role that any documentation could play in avoiding any significant, identified risks.
 

Randy

Super Moderator
#8
Ask multiple people about what is supposed to happen and then verify whether or not it is through observation.

Evidence can be acquired through interview, observation and review of documentation and records.....Auditing 101
 
#9
Joe:

It's basically very simple. You ask the manager responsible for the process what happens (what's the process?) - make lots of notes! Then you go and ask the people who perform the process what happens (show me!) and you verify one 'story' against the other, you check records to see if they can prove it's happening as described and, don't forget, that it's effective.......
 
C

CliffK

#10
I am in the process of carrying out an audit on our incoming materials Dept. (stores) The company I work for do not have any written instructions and they do not inspect any product, the components go straight into storage and when required are issued to the shop floor.
Andy pretty much nailed the right answer...

I would say it in a slightly different way.

Clause 7.4.3 says, "The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements."

Your questions should be:
- Since there's no inspection, what is the planned method of ensuring purchased product meets specified requirements?
- Does the available evidence show that the planned method is working?

Available evidence could be failure rates on the factory floor or at the customer. What does the service department say about product reliability?
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
S ISO 9001:2015 Internal Auditing Internal Auditing 8
H Auditing Santa's workshop General Auditing Discussions 0
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
F AS9100D Internal auditing requirements Internal Auditing 11
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
Richard Regalado ISMS Auditing Guideline V2 (based from ISO/IEC 27001:2013) IEC 27001 - Information Security Management Systems (ISMS) 7
S ISO 9001:2015 - Internal Auditing - Audit to the Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom